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November 2021

Medical products

Intensify actions to fight substandard and falsified medical products. Urgent appeal to “false breakers”

“Health is not a hoax – Fight the fakes” is the slogan for this year’s Fight the Fakes week. The aim is to highlight how substandard and falsified medicines pose serious risks to human health and have disastrous consequences for the well-being of communities and the socio-economic stability of each country. They deserve much more attention in international fora.

Fight the Fakes Alliance invites organizations and individuals around the world to become fake busters for this year’s Fight the Fakes week, December 6-12, and to help raise awareness of the dangers involved.

Sometimes substandard and falsified drugs can have tragic consequences. They are contributing to the development of the second global health emergency after COVID-19: antimicrobial resistance and drug-resistant infections. They create mistrust in drugs, health professionals and health systems and block the socio-economic development of a country. The problem is most acute in low- and middle-income countries, with estimates suggesting that up to 1 in 10 medical products are either substandard or falsified.

Since the start of the COVID-19 pandemic, diagnostic tests, personal protective equipment (PPE), potential therapies and vaccines have been found to be falsified across the world. The World Health Organization (WHO) has issued several medical product alerts related to COVID-19 vaccines and treatments over the past two years, while the Infectious Disease Data Observatory collects hundreds of reports from the field public on substandard and falsified COVID-19 medical products. and COVID-19 vaccines.

As the rollout of COVID-19 vaccination accelerates, criminals are capitalizing on shortages or barriers to access, but also waves of vaccine hesitation. It may also accelerate the spread of counterfeit products that are unrelated to COVID-19, proving a flourishing global business of substandard and falsified medical products, without regard for the health impacts.

About Fight the Fake Alliance

The Fight the Fakes Alliance (aka “Fight the Fakes”) is a non-profit, multi-party association that aims to raise awareness of the dangers of falsified and substandard medicines. He gives voice to those who have been personally affected and shares the stories of those working to end this threat to public health. He seeks to build a global movement of organizations and individuals who will shed light on the threat these so-called drugs pose to patient safety and health systems and to achieving universal health coverage. The diverse members of Fight the Fakes share the belief that coordination among all stakeholders working along the medical supply chain is essential if we are to tackle this threat to global health.




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Medical products

Medical Products Supply Chain Weekly Review – FDA Approves Pfizer and Moderna Booster for All Adults | Alston & Bird

Over the past week, the FDA cleared the Pfizer and Moderna booster injections for all adult age groups, while the CDC’s Advisory Committee on Immunization Practices (ACIP) also recommended the Moderna vaccine booster. for all adults. Pfizer has submitted an Emergency Use Authorization (EUA) application for its oral treatment with COVID-19. President Biden signed the Infrastructure Investments and Jobs Act and the Executive Order for its implementation. The FDA has issued updated guidelines for manufacturers of SARS-CoV-2 tests. Please see details of these and other supply chain developments below:

  • On November 15, the President signed the Law on Investment in Infrastructure and Employment (IIJA) and a decree to facilitate its implementation. IIJA Amends Homeland Security Act 2002 to Allow Secretaries of Homeland Security, Health and Human Services (HHS) Departments, and Veterans to Transfer Personal Protective Equipment (PPE) and Equipment medically necessary for the national stock under a production contract during a public health emergency declared by the secretary of the HHS. In general, the Secretary of Homeland Security, at the request of the Secretary of HHS, is authorized to transfer to HHS, for reimbursement, excess PPE or medically necessary equipment possessed by the Department of Homeland Security (DHS). The DHS Secretary must determine whether the requested personal or medically necessary protective equipment is surplus equipment and certify that the transfer of such equipment will not have a negative impact on the health or safety of officers, employees or subordinates. treating DHS. The IIJA is also amending the Public Health Services Act to allow the Secretary of HHS, in coordination with the Secretary of DHS, to sell drugs, vaccines (and other biologicals), medical devices, or supplies. within the national stock to a federal agency, nonprofit, state, or local, tribal, or territorial entity. Products sold must be within one year of expiration or determined to be no longer needed in inventory due to advances in medical or technical capacity. The IIJA also includes a subtitle “Make PPE in America Act” which requires the development of a short-term (three-year) and long-term strategy for the national production of PPE. An Infrastructure Implementation Working Group has been established to oversee the implementation of the law. The working group will be co-chaired by Mitch Landrieu, White House Infrastructure Implementation Coordinator, and Brian Deese, Director of the National Economic Council.
  • On November 15, the FDA updated its policies regarding COVID-19 test review expectations and released several policies that provide guidance to manufacturers. The FDA’s goal is to ensure that the tests are reliable and accurate. The update included the following:
    • The FDA has re-issued the “Policy for Testing for Coronavirus-2019 Disease During Public Health Emergency (Revised),” which applies to tests that use diagnostic and serological methodology. Manufacturers can submit EUA requests for home and point-of-care testing, high-volume laboratory molecular diagnostic testing, high-volume laboratory and point-of-care antibody testing, and funded testing by the US government agency. All other types must use traditional pre-market channels.
    • The FDA has published the “Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing”. This EUA applies to certain SARS-CoV-2 serial use nasal swab tests, which are used in testing programs by schools, workplaces or community groups. Testing should be performed in a single CLIA certified laboratory.
    • The FDA reissued the EUA, “Laboratories that have developed a molecular test (LDT) for coronavirus disease 2019 (COVID-19)”. In its review of current policies and the changing needs of the pandemic, the agency is prioritizing serial use testing and has updated its conditions for authorizing molecular-based laboratory-developed tests. Additional tests may be permitted.
    • The FDA has issued guidance on its “Viral Transport Media Enforcement Policy During Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” Due to the increase in serial testing, there is a need to increase the availability of transport media for clinical specimens. The FDA created this guide to support this effort and provide a standard for media manufacturers. The guide specifically provides criteria for commercial manufacturers on validation, agency notification and labeling expectations. Additional guidance and expectations are included for manufacturers of alternative media types and saline transport media.
  • On November 16, Pfizer announced the submission of an EUA application for its COVID-19 oral antiviral drug, Paxlovid (ritonavir). The medicine is intended for home use in high-risk patients to prevent hospitalization and death. According to an interim review from the Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients (EPIC-HR) trial, a phase 2/3 study, Paxlovid demonstrated a relative risk reduction of 89% (risk reduction absolute 6.2%) of hospitalization and death in participants 18 years and older at high risk for disease progression. Recruitment for the trial was discontinued upon recommendation of the Data Oversight Committee based on interim analysis data. Trials for standard risk patients and post-exposure prophylaxis are still ongoing. On the same day, Pfizer agreed to license Paxlovid to the Medicines Patent Pool, a United Nations-backed entity, to provide access to the drug to low- and middle-income countries. On November 18, Pfizer announced an agreement with the US government to supply 10 million courses of Paxlovid, subject to regulatory clearance from the FDA.
  • On November 16, the Center for Devices and Radiological Health (CDRH) updated the Medical Device Development Tools program documents landing page. The program is voluntary and supports sponsors in the development and evaluation of their medical devices with the aim of facilitating the review of CDRH. The program’s tools are evaluated and approved by the FDA and must be capable of producing scientifically plausible results.
  • On November 17, the White House COVID-19 response team announced that the administration was planning to provide funding to increase vaccine production. The Department of Health and Human Services is in contact with manufacturing companies that can increase their vaccine production. The goal is to add at least one billion doses to the national supply through investments in infrastructure and training.
  • On November 19, the FDA cleared the Pfizer and Moderna vaccines for use as a booster dose in all age groups 18 years and older. The agency based its decision on data from ongoing clinical trials and real-time results from vaccine use. The authorizations relate to a booster dose at least six months after the end of the initial series. The CDC ACIP then met and unanimously recommended that the Moderna vaccine be allowed for people 18 years of age and older. The committee’s decision has been forwarded for approval to CDC director Dr. Walensky and the FDA.

[View source.]

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Generic drugs

Medkart: Generic Medkart Retail Chain Raises Rs 40 Crore In Series A Cycle

Medkart, the Ahmedabad-based generic drug retail pharmacy chain, said on Tuesday it had raised Rs 40 crore in its Series A cycle from Alkemi Growth Capital and Insitor Partners with the participation of angel investors , including Prashant Poddar and other UAE professionals and former CEOs of IIFL Asset Management.

Medkart, founded by Ankur Agarwal and Parsharan Chari, is an omnichannel pharmacy that helps people lower their medical bills through access to the best quality generic drugs at the most affordable rates.

Founded in 2014, Medkart provides generic medicines certified by WHO GMP in its network of more than 75 stores in more than 22 cities.

Medkart says it cuts medical costs by up to 85% and has saved more than Rs 200 crore for its clients to date.

The company said it has a loyal base of over 600,000 chronic disease patients and derives 80% of its revenue from loyal customers.

The company has so far focused on building a robust supply chain and improving final delivery to customers.

During its founding years the company was started up, quickly achieved a positive unity economy, and gradually expanded its operations across Gujarat and Rajasthan. More recently, she has embarked on building online channels to add a more personalized experience to the customer.

Speaking about fundraising, Ankur Agarwal, Co-Founder, said, “Every year 6 crores of Indians are plunged into poverty due to medical expenses. Considering that drugs are a basic need especially for chronic patients, we aim to disrupt the way drugs are consumed in India. As a technology company, we always aim to serve our customers no matter which channel they are comfortable with. ”

Mumbai-based investment bank Radix Capital Advisors acted as exclusive financial advisor to Medkart.

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Medical supplies

New UPS Healthcare facility to help distribute temperature-controlled medical supplies

New UPS Healthcare facility to help distribute temperature-controlled medical supplies

UPS Healthcare is opening a new facility in Louisville with cold chain capabilities to expand the global delivery of temperature-controlled healthcare supplies, according to Louisville Business First. The new distribution center, 6204 New Cut Rd., Is located near UPS Worldport. “We strive to make sure that all of our buildings are truly the same in terms of process quality,” said Warren Olson, vice president of UPS Supply Chain Solutions. “We have a global quality system, so when you walk into a facility in Louisville, Ky., Or walk into a facility in Singapore, the only thing you should notice that is different is the accent of the people who take you on a visit. “The building will be used to house and distribute health products, including pharmaceuticals, medical devices and biologicals at room temperature, said Olson. Cold chain refers to supply chains to temperature controlled, which means that a product is produced, stored and distributed at the same time low temperature range. The cold chain capabilities of the center allow it to store temperature controlled devices in coolers and freezer, with temperatures of 20 to 25 degrees Celsius and -20 degrees Celsius, respectively. The total number of employees at the facility is undecided, but UPS Healthcare is currently hiring 400 positions, including entry and management levels. Olson said facilities of this size typically house 250 employees. The cold chain packaging center is now operational, but the rest of the facility is expected to begin operations by the first quarter of 2022. You can read more about the details in the full Louisville Business First file. . article here.

UPS Healthcare is opening a new facility in Louisville with cold chain capabilities to expand the global delivery of temperature-controlled healthcare supplies, according to Louisville Business First.

The new distribution center, 6204 New Cut Rd., Is located near UPS Worldport.

“We strive to make sure that all of our buildings are truly the same in terms of process quality,” said Warren Olson, vice president of UPS Supply Chain Solutions. “We have a global quality system, so when you walk into a facility in Louisville, Ky., Or walk into a facility in Singapore, the only thing you should notice that is different is the accent of the people who take you on a tour. “

The building will be used to house and distribute health products including pharmaceuticals, medical devices and room temperature biologicals, Olson said.

The cold chain refers to temperature-controlled supply chains, which means that a product is manufactured, stored and distributed in the same range of low temperatures. The centre’s cold chain capabilities allow it to store temperature-controlled devices in coolers and a freezer, with temperatures of 20 to 25 degrees Celsius and -20 degrees Celsius, respectively.

The total number of employees at the facility is undecided, but UPS Healthcare is currently recruiting 400 positions, including entry and management levels. Olson said facilities of this size typically house 250 employees.

The cold chain packaging center is now operational, but the rest of the facility is expected to start operating by the first quarter of 2022.

You can read more about the details in the full Louisville Business First article here.

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Medical products

Precision Medical Products Launches Most Durable Portable Compression Device on the Market

ROCKLIN, Calif., November 19, 2021 / PRNewswire / – Today, Precision Medical Products (PMP) announced the release of the latest version of its Circul8 Pro® device, a powerful and portable on-the-go deep vein thrombosis (DVT) prevention product. Now with over 20 hours of battery life, the Circul8 Pro® is the most durable portable battery-operated compression device on the market.

“Our company continues to innovate and raise the bar of standards of care as we position ourselves as the clear leader in DVT prevention,” said the CEO of Precision Medical Products. Jeremy Perkins.

The device from Precision Medical Products exceeds guidelines recommended by industry experts for the prevention of perioperative DVT, such as the Association of Perioperative Registered Nurses (AORN). The AORN recommendations are based on a study by the American College of Chest Physicians, whose guidelines recommend 18 hours of use of DVT prevention devices. Patients using the Circul8 Pro® will be equipped with a device that allows ease of movement without the need for constant recharging.

“Our 20+ hour battery makes patient compliance easy, paving the way for the best possible outcome,” Perkins concluded.

In addition to the latest version of Circul8 Pro®, Precision Medical Products’ existing range of offerings include the CIRCUL8® brand and VenaOne®, a mobile DVT prevention system for hospital use. The Circul8 Pro® and VenaOne® are self-contained and wireless, allowing maximum mobility. PMP also offers PreVent®, the only remote DVT prevention and monitoring solution available.

About precision medical products: Since launching as a self-funded startup in 2010, Precision Medical Products has been helping patients recover from surgery, using its innovative DVT prevention products, programs and offerings. Precision Medical Products was recognized on Inc. 5000’s list of America’s fastest growing companies and received a variety of innovation awards for its patented products.

SOURCE Precision Medical Products

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Medical supplies

MedX Health Corp. and Al Zahrawi Medical Supplies LLC Announce Distribution Agreement for State-of-the-Art Teledermatology Screening Platform in United Arab Emirates

MISSISSAUGA, Ontario – (COMMERCIAL THREAD) –MedX Health Corp. (“MedX” or the “Company”) (TSX Venture Exchange: MDX) and Al Zahrawi Medical Supplies LLC (“Al Zahrawi”) are pleased to announce a Memorandum of Understanding between the companies on a two-phase commercialization pilot and distribution agreement for MedX’s industry-leading DermSecure® screening platform in select clinics UAE Oncology and Dermatology (“UAE”) starting this month.

The three-month pilot project will involve around 1,000 patients at four dermatology and oncology clinics in Abu Dhabi and Dubai. Upon successful completion of both phases, the MedX DermSecure® screening platform will become more widely available in clinics and healthcare facilities in the United Arab Emirates. As the largest distributor of medical devices in the Gulf Cooperation Council (GCC) region, the partnership with Al Zahrawi positions MedX for continued growth in other Middle Eastern markets including Saudi Arabia, Qatar, Oman and Bahrain. This initiative is the latest in a series of recently launched commercialization pilots in Europe and the Middle East as part of MedX’s global commercialization strategy, building on ongoing pilots in the Netherlands, Italy and Turkey. Other pilot marketing projects are planned in the coming months.

“At Zahrawi, we are passionate about providing the highest quality products and services to healthcare facilities and CCG laboratories,” said David Fawzy Yassa, Director of Business Development at Al Zahrawi. “MedX’s teledermatology platform meets these high standards, with a proven ability to improve patient outcomes in dermatology. We look forward to working with MedX to bring the platform to more patients in the UAE market and other GCC countries. ”

Teledermatology is a subspecialty of dermatology that provides safe and effective virtual care – patient screening and assessment – eliminating the need for in-person appointments with a dermatologist. Unlike other teledermatology screening tools available, MedX’s DermSecure® screening platform features high-resolution image capture technology for moles, lesions and other skin conditions, providing a comprehensive dermatological assessment. and virtual by a certified dermatologist in just 72 hours.

MedX’s leading telemedicine platform enables healthcare professionals to quickly and accurately assess suspicious moles, lesions and other skin conditions through its image capture technology, SIAscopy®, and its imaging system. Cloud-based secure patient management, DermSecure®, which transmits and stores patient data throughout the assessment process. MedX’s SIAscopy® is the only technology that captures five images, including four spectrophotometric images 2mm below the skin’s surface.

Sylvain Desjeans, CEO of MedX, said: “This pilot is an important step in growing MedX’s global presence, particularly in countries in the GCC region. In this time of rapid growth for our business, we look forward to working with trusted partners like Al Zahrawi to expand our global footprint and further improve patient outcomes. ”

Naman Demaghlatrous, Managing Director of MedX for Europe, Middle East and Africa, added: “Our pilot in the United Arab Emirates is an important foothold in the GCC region – it represents the first of six. markets that we want to enter in the Middle East. Following the success of this pilot project in the United Arab Emirates, we will be looking for other similar opportunities in Saudi Arabia and other GCC countries in the coming months. ”

According to Omnia Health, melanoma of the skin is of growing concern in the United Arab Emirates as one of the most common malignancies in men, with an incidence rate of 14.5%.1 The World Health Organization estimates cancer rates in the Middle East will double by 2030.2 Early and rapid detection of melanoma is essential to improve patient outcomes.

About MedX Health Corp. :

MedX, headquartered in Ontario, Canada, is a leading medical device and software company focused on skin health with its SIAscopy® telemedicine platform on DermSecure®, using its SIAscopy® technology . SIAscopy® is also integrated into its SIAMETRICS®, SIMSYS® and MoleMate® products, which MedX manufactures in its ISO 13485 certified factory. SIAMETRICS®, SIMSYS® and MoleMate® include hand-held devices that use patented technology using light and its transfer to visualize up to 2mm below moles and suspicious lesions in a painless and non-invasive way, with its software then creating real – time images allowing doctors and dermatologists to assess all types of moles beauty or lesions in seconds. These products are authorized by Health Canada, the United States Food and Drug Administration, the Therapeutic Goods Administration and the European Conformity for use in Canada, United States, Australia, New Zealand, European Union , Brazil and Turkey. Visit https://medxhealth.com/.

About Al Zahrawi Medical Supplies LLC:

Zahrawi Group is a leading company dedicated to contributing to the markets of UAE, Saudi Arabia, Qatar, Bahrain and Oman by providing high quality products and services to hospitals, clinics, laboratories and analytical industries. The Zahrawi Group is constantly expanding, progressing and contributing to the prosperity of the people and the economy of the region. Zahrawi Group represents a wide range of internationally renowned healthcare and laboratory manufacturers, such as Medtronic, Agilent Technologies, Dako, Sakura, BD, Sysmex, Cepheid, Hitachi, Sebia and many more. The Zahrawi group continues to show sustainable growth year on year with a turnover of 583 million Dhs in 2020. Visit https://www.zahrawigroup.com/.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

This press release may contain forward-looking statements, which reflect the Company’s current expectations regarding future events. Forward-looking statements involve risks and uncertainties.

____________________________

1 https://insights.omnia-health.com/medical-specialities/skin-cancer-growing-public-concern-uae

2 https://www.thenationalnews.com/uae/uae-doctors-highlight-skin-cancer-risk-1.891696

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Medical products

Recbio Receives Pharmaceutical Production License From Jiangsu Medical Products Administration For Production Of COVID-19 Vaccine

TAIZHOU, China, November 16, 2021 / PRNewswire / – Jiangsu Recbio Technology Co., Ltd. (“Recbio”), a biopharmaceutical company specializing in the research, development and commercialization of innovative vaccines capable of combating widespread diseases with significant burdens, recently announced that the company has received the Pharmaceutical Production License (scope: COVID-19 recombinant two-component vaccine [CHO cell]) issued by the Jiangsu Medical Products Administration (JSMPA). It indicates that the Recbio production plant in Taizhou, Jiangsu Province, China (Taizhou facility) qualified to manufacture COVID-19 two-component recombinant vaccine [CHO cell] (ReCOV), which means that Recbio has taken another important step towards a vaccine business with a full industry chain spanning research, production and commercialization.

The newly constructed state-of-the-art production facility has been designed in accordance with current Good Manufacturing Practices (cGMP) standards. With a total GFA of over 17,000 m², the Taizhou factory has an annual production capacity of over 100 million doses, which can quickly be expanded to 300 million doses per year.

Over the past 10 years, new adjuvants have been gradually applied in the vaccine industry and have brought about profound changes to the industry. Recbio is one of the few companies with commercial production capacity for new adjuvants that have been approved by the FDA for human use. As a result, the vaccines developed by the company not only have peak performance, but also do not depend on any particular adjuvant supplier. Equipped with a novel adjuvant BFA03 developed in-house and AS03 benchmarking, ReCOV demonstrated excellent immunogenicity, safety and tolerability in the phase I clinical study in New Zealand. In particular, the titer of neutralizing antibodies induced by ReCOV was not lower than that induced by international general public mRNA vaccines. ReCOV is expected to apply for an EUA (Emergency Use Authorization) in the first half of 2022.

About the two-component COVID-19 recombinant vaccine (ReCOV)

In May 2020, Recbio, in collaboration with the Jiangsu Provincial Center for Disease Control and Prevention (“Jiangsu CDC”) and Taizhou Medical New & High-tech Industrial Development Zone, jointly developed a two-component recombinant COVID-19 vaccine (ReCOV). Under the leadership of Professor Fengcai Zhu from Jiangsu CDC, the R&D team thoroughly optimized the vaccine using protein engineering and new adjuvant technologies so that ReCOV shows promising safety and strong immunogenicity against SARS. -CoV-2 and variants of concern such as Delta. A series of comprehensive advantages such as better cross-protection against emerging variants, easy production scale-up, cost advantages, global accessibility, good preparation stability, as well as a storage and transport at room temperature is becoming a new, very competitive second-generation COVID-19 vaccine.

About Recbio

Recbio is an innovative vaccine company founded in 2012. With the vision of “Becoming the leader in innovative vaccines in the future”, Recbio’s mission is to “Protect human health with the best vaccines in its class”. It has established three major cutting-edge technology platforms, including a platform for novel adjuvants, a protein engineering platform and an immunoassessment platform. Recbio has a high-value vaccine portfolio comprising HPV vaccine candidates, COVID-19 vaccine candidates, shingles vaccine candidates, influenza vaccine candidates, adult tuberculosis vaccine candidates, and more. The core scientific team has more than 20 years of experience in the development and commercialization of innovative vaccines. For more information, please visit https://www.recbio.cn/.

Forward-looking statements

This press release may contain certain forward-looking statements which are, by their nature, subject to important risks and uncertainties. The words “anticipate”, “believe”, “estimate”, “expect”, “intend” and similar expressions, with respect to Recbio, are intended to identify certain of these forward-looking statements. Recbio does not intend to regularly update these forward-looking statements.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Recbio regarding future events at the time these statements are made. These statements do not constitute a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Recbio’s control and are difficult to predict. Therefore, actual results may differ materially from information contained in forward-looking statements due to future changes or developments in our business, Recbio’s competitive environment and political, economic, legal and social conditions.

Jiangsu Recbio Technology Co., Ltd.

Investor survey:
E-mail: [email protected]
Phone. : + 86-0523-86818860

Media investigation:
E-mail: [email protected]
Phone. : + 86-0523-86818860

SOURCE Jiangsu Recbio Technology Co., Ltd.

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Medical products

Medical Products Supply Chain Week Review – November 2021 # 2 | Alston & Bird

Last week, the president chose Dr. Robert Califf to be the commissioner of the FDA. Congress passed the Infrastructure Investment and Jobs Act. New vaccination requirements have been issued by OSHA and CMS for some employers. In addition, the State Department has updated its rules for passengers entering the United States. Please see details of these and other supply chain developments below:

  • On November 4, the Department of Labor’s Occupational Safety and Health Administration (OSHA) announced a new Temporary Emergency Standard (ETS) that requires companies with 100 or more employees to develop a vaccination policy. against COVID-19. Requirements include that companies check the immunization status of each employee, require proof of vaccination, and keep records. Additionally, unvaccinated employees would be subject to weekly testing, early notification of a positive COVID-19 diagnosis, and a quarantine strategy. Employers have 60 days to comply with all of the requirements. In the meantime, lawsuits have been filed with the United States’ Courts of Appeals for the Fifth, Sixth, Seventh, Eighth, Eleventh and DC Circuits to review the legality of the order. While the Fifth Circuit has granted an emergency motion to suspend the OSHA HTA, cases will be consolidated and transferred to one circuit through a lottery system. The complainants argue that OSHA does not have the specific legislative authority to establish this rule and is in violation of the doctrine of non-delegation. For more information, see Alston & Bird’s Labor and Employment / Healthcare advisory, “What You Need to Know About OSHA’s ETS for Employee Vaccination Requirements” .
  • On November 4, the Centers for Medicare & Medicaid Services (CMS) issued emergency regulations requiring the full immunization of some health facility staff by January 4, 2022. The agency’s data collection determined that these requirements have not led to a critical shortage of personnel from the widespread resignation of essential personnel. For any non-compliant entity, CMS has committed to use its executing authority to take further action.
  • On November 6, Congress passed the Infrastructure Investment and Jobs Act. The law will provide funding for large infrastructure projects to “strengthen our supply chains and avoid the disruptions that have caused inflation.” The 10-year plan provides for $ 17 billion in funding for the modernization of port infrastructure and $ 25 billion in funding for US airports. The bill awaits the president’s signature.
  • On November 9, Pfizer and BioNTech submitted a request to change their Emergency Use Authorization (EUA) for the booster dose of the COVID-19 vaccine. The amendment would allow the booster dose to be authorized for all persons 18 years of age and over. The claim is based on data from a Phase 3 clinical trial which demonstrated the booster to be 95% safe and effective.
  • On November 10, the Administration announced action plans to improve the flow of goods through the supply chain and the progress made so far. The amount of cargo that passed through the ports of Los Angeles and Long Beach reached an all-time high. The Administration plans to facilitate the movement of goods by working with key stakeholders to operate the ports 24/7, including removing fees for truckers who collect cargo overnight and on weekends. , reducing rail rates for shipping to ports on weekends and encouraging retailers to use off-peak weekend hours for supply chain activities.
  • On November 12, President Biden will appoint Dr. Robert Califf as FDA commissioner. Califf previously served as commissioner during the Obama administration and is expected to receive bipartisan support. The announcement is expected today.
  • The FDA has issued “Product Specific, Interim and Revised Guidelines” to help manufacturers develop bioequivalence studies to use in their Abbreviated New Drug Application (ANDA) submissions. The guidelines and draft guidelines will apply to the products explicitly listed. The deadline for submitting comments is January 2, 2022.

[View source.]

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Medical supplies

Over $ 1 million in medical supplies to be delivered to rural African villages by Denver organizations

COVID has only made the problem worse and made it more difficult for rural areas to obtain medical supplies. From personal protective devices (PPE) to life-saving supplies to basic durable health goods, global demand has caused serious supply chain problems and rising prices. For rural and poor communities that already suffer from a lack of resources, this often means going without significant medical care and supplies.

“Our medical staff is at the service of patients in Denver every day “, said Shay kerman, COO of Emergency Care Solutions at Denver. “It’s easy to take for granted access to high-quality medical care like we have here, while other places suffer from lack of access to basic medical supplies and life-saving equipment. “

To help meet this need, Urgent Care Solutions and Project CURE have teamed up to send two containers of durable medical goods to Ghana and Senegal. Urgent Care Solutions pays the cost and their team members help collect the supplies and ship them to Africa.

“I saw the need firsthand,” Kerman said. “During my work in Ghana with groups of volunteers providing medical assistance, I saw tiny villages that had limited access to water, let alone medical supplies. “

At November 10e, Dairus and Shay Kerman, along with staff from AFC Urgent Care Denver, helped sort, assemble, pack and ship medical supplies to Project CURE’s nonprofit headquarters in Centenary, CO.

Medical supplies worth millions will be distributed by local health care providers.

“I am very excited about this partnership. Our head office is here in Denver and donations from a local organization like Urgent Care Solutions help us fulfill our mission, ”said Dr. Douglas jackson, President and CEO of Project CURE “Due to COVID, there is an even greater need for medical services and supplies in underserved countries. “

The CURE project provided more than $ 48 million in medical supplies donated in the United States and abroad. Donated medical supplies and equipment are provided free of charge to local health care providers serving remote areas.

About emergency care solutions

Urgent Care Solutions dba AFC Urgent Care has 9 sites serving more than 150,000 patients each year in Denver and Aurore, Colorado. AFC Urgent Care provides prompt and comprehensive medical care with short wait times and reasonable rates.

About the CURE project

Project CURE is the world’s largest distributor of donated medical equipment and supplies. They deliver these supplies to resource-limited communities around the world in more than 135 countries. Project CURE accepts donations from medical supply companies, hospitals, healthcare providers, and consumers.

Linked in the publication

Emergency care solutions in Denver is partnering with Project CURE to send millions of dollars in medical supplies to rural African villages in desperate need. Yesterday, the medical staff and management of Urgent Care sorted, assembled, packed and shipped much-needed medical supplies.

SOURCE Emergency Care Solutions

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Generic drugs

The size of the generic drugs market will exceed approximately US$574.63 billion

Ottawa, Nov. 09, 2021 (GLOBE NEWSWIRE) — According to the new study report released by Precedence Research, titled “Generic drugs market By Drug Type, Brand, Drug Delivery Route, Therapeutic Application and Distribution Channel: Global Opportunities Analysis and Industry Forecast 2021-2030”, the increasing prevalence of chronic diseases, especially cardiovascular disorders, propelled the demand for the generic drug market.

Generic drugs are overwhelming the pharmaceutical industry market with record growth and enduring market trend making it a lucrative field in which to operate.

The report is ready | Obtain Sample Copy report OR any customization requirements @ https://www.precedenceresearch.com/customization/1205

A generic drug includes the same chemical substance as a drug that was previously protected by a chemical patent. After patents on originator pharmaceuticals expire, generic drugs can be sold. It is believed that the medical profile of generics is equal in terms of performance because the active chemical ingredient is the same. The generic drug contains the same active pharmaceutical ingredient (API) as the brand name drug, but it may change in terms of manufacturing technique, formulation, excipients, color, taste, and packaging. The cost effectiveness of generic drugs has contributed to a competitive advantage over branded drugs and is the major factor driving the growth of the market.

The crucial factors responsible for the growth of the market are:

  • The low cost of generics as an alternative to branded drugs
  • A large number of expired brand name drug patents
  • Initiatives by governments and other regulatory bodies around the world

The expiration of brand name drug patents opens up new avenues for generic drug players to enter on the market

The patent expiration of brand name drugs is constantly increasing, providing huge potential opportunities in the drug market. Generic drug manufacturers have constantly focused on developing and launching different innovative drugs as well as formulations such as biosimilars that enhance the market growth. Additionally, government initiatives to promote the manufacture of generic drugs for life-threatening chronic diseases have further propelled the growth of the market in emerging economies especially. Additionally, growing aging populations across the globe that are more prone to various diseases has fueled the growth of the market.

Global generic drugs market size and estimates, by brand, 2021-2027 (USD billion)

Brand segment 2021 2023 2025 2027 CAGR (2021-27)
Branded Generics 200.60 234.66 272.41 313.86 7.75 %
Pure Generics 213.96 230.32 246.06 260.77 3.35 %
Total 414.56 464.98 518.45 574.63 5.59 %

Oral generics seeking benefit due to their most common mode of drug delivery

The major advantages associated with oral generics such as convenience of oral drug administration, patient preference, cost-effectiveness and ease of large-scale manufacturing of oral dosage forms, oral medication is the mode of administration of the most common drugs. About 65% of commercially available generic drugs are taken orally. Oral formulations account for approximately 90% of the global market share of all pharmaceutical formulations for human use, according to current estimates. Oral pharmaceuticals account for approximately 84% of top-selling pharmaceuticals. They are the major contributor to the growth of the market due to the preferred and cheap option. Additionally, they are patient-friendly, especially in geriatric and pediatric populations, and are relatively easy to create compared to their larger molecular rivals.

KEY POINTS OF THE STUDY

  • The oral segment of the route of administration is believed to be growing at a remarkable rate and accounted for the largest share throughout the study period.
  • Branded generics dominate the generic drug market in 2020, but pure generics are expected to overtake branded generics by 2027.
  • The Asia-Pacific region is expected to grow at the fastest CAGR over the forecast period owing to the rapid penetration of local players in the market.
  • North America dominated the generic drug market and is expected to maintain its trend throughout the forecast period.
  • The therapeutic cardiovascular applications segment showed a large revenue share in 2020, while the oncology segment is poised to grow at the fastest rate in the foreseeable future.
  • Retail pharmacy occupies the leading position in the distribution channel segment; however, online distribution is growing at a significant rate during the forecast period.

Asia Pacific region to gain traction in the global generic drugs market due to lower manufacturing cost and highly skilled labor

Asia-Pacific is expected to show significant traction in the market over the forecast period. This is attributed to lower manufacturing costs and highly skilled labor in Asian countries. According to the India Brand Equity Foundation, India has the second highest number of US FDA manufacturing plants outside the United States involved in the manufacture of generic drugs. In addition, the manufacturing cost is 33% lower in India than in the United States, which increases the accessibility of generics in these countries.

Global generic drugs market size and estimates, By Region, 2021-2027 (USD billion)

Region 2021 2024 2027 CAGR (2021-27)
North America 149.46 165.00 178.77 3.03 %
Europe 121.34 136.67 151.47 3.77 %
Asia Pacific 98.08 130.01 168.14 9:40 a.m. %
Latin America 29.99 38.88 49.36 8.66 %
Middle East and Africa 15.69 20.79 26.89 9:40 a.m. %
Total 414.56 491.35 574.63 5.59 %

Asia-Pacific has focused on increasing the supply of medicines at lower prices, even if this requires buying from non-traditional sources, with historically low generic drug use . Therefore, emerging countries such as India and China supplement the growth of the generics market.

In 2019, generic pharmaceuticals and biosimilars saved the US healthcare system $313 billion, including $96 billion in Medicare savings and $48.5 billion in Medicaid savings. Generics fill 90% of prescriptions in the United States for just 20% of the cost, at a time when access to reliable, inexpensive, high-quality prescription drugs is more critical than ever. In 2019, the average primary copayment for generic drugs was $6.97 compared to an average primary copayment for brand name drugs of $56.32. These supporting factors are expected to drive generic drug sales over the next few years.

Browse more health industry research reports @ https://www.precedenceresearch.com/industry/healthcare

Market Competitiveness and Business Prospects

The global generic drugs market is fragmented owing to the presence of several large and small companies spread across the globe. Major market players are adopting new strategies to gain market appeal. The report provides in-depth competitive analysis and profiles of major market players, such as Mylan NV, Abbott Laboratories, ALLERGAN, Teva Pharmaceutical Industries Ltd., Eli Lilly and Company, STADA Arzneimittel AG, GlaxoSmithKline Plc., Baxter International Inc., Pfizer Inc., Sandoz International GmbH and others. Other players operating in the value chain are AurbindoPharma, Sun Pharmaceutical Industries Ltd., Aspen Pharmacare, Fresenius Kabi Ag, Lupin, Novartis, Glenmark, Sawai, PiramalPharma Solutions, Hikma, Cipla, Dr. Reddy’s, Endo, Stada and Mallinckrod, among others.

Main market segments covered:

By type of drug

By brand

By route of drug administration

By therapeutic application

  • Central nervous system (CNS)
  • Cardiovascular
  • Dermatology
  • Oncology
  • Respiratory
  • Others

Key distribution channel

  • Hospitals Pharmacies
  • Retail pharmacies
  • Others

By geography

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa (MEA)

Click here to View full report table of contents

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Precedence Research is a global market research and consulting organization. We provide an unparalleled nature of offering to our customers located all over the world across industry verticals. Precedence Research has expertise in providing in-depth market intelligence as well as market insights to our clients spread across various businesses. We are obligated to serve our diverse customer base in medical services, healthcare, innovation, next-generation technology, semiconductor, chemical, automotive, aerospace and defence, among the various companies present in the world.

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Generic drugs

Generic Drugs Market Size To Exceed US $ 574.63 Billion

Ottawa, November 09, 2021 (GLOBE NEWSWIRE) – According to the new study report released by Precedence Research, titled “Generic drugs market by drug type, brand, drug route of administration, therapeutic application and distribution channel: analysis of global opportunities and industry forecast, 2021-2030 ”, the increasing prevalence of chronic diseases, especially cardiovascular disorders, has propelled the market demand for generic drugs.

Generic drugs are crushing the pharmaceutical industry market with record growth and a sustainable market trend, making it a lucrative area in which to operate.

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A generic drug contains the same chemical substance as a drug that was previously protected by a chemical patent. After the patents on the original pharmaceuticals expire, generic drugs can be sold. The medical profile of generics is considered to be equal in terms of performance because the active chemical ingredient is the same. The generic drug contains the same active pharmaceutical ingredient (API) as the brand name drug, but it can change in terms of manufacturing technique, formulation, excipients, color, taste and packaging. The profitability of generic drugs has contributed to a competitive advantage over brand name drugs is the main factor adding to the growth of the market.

The crucial factors responsible for the growth of the market are:

  • The low cost of generics as an alternative to brand name drugs
  • Large number of brand name drug patents expired
  • Initiatives from governments and other regulatory bodies around the world

The expiration of brand name drug patents to open up new avenues for generic drug players to enter on the market

The expiration of brand name drug patents continues to increase, offering huge potential opportunities in the drug market. Generic drug manufacturers have constantly focused on developing and launching various innovative drugs as well as formulations such as biosimilars which are helping in the growth of the market. In addition, government initiatives to promote the manufacture of generic drugs for deadly chronic diseases have further stimulated the market growth in emerging economies in particular. In addition, the growing aging populations across the world who are more prone to various diseases have fueled the growth of the market.

Global Generic Drugs Market Size and Estimates, by Brand, 2021-2027 (USD Billion)

Brand segment 2021 2023 2025 2027 TCCA (2021-27)
Brand generics 200.60 234.66 272.41 313.86 7.75 %
Pure generics 213.96 230.32 246.06 260.77 3.35 %
Total 414.56 464.98 518.45 574.63 5.59 %

Oral generics seeking an advantage due to their most popular route of drug administration

Major advantages associated with oral generics such as convenience of oral drug administration, patient preference, cost-effectiveness, and ease of large-scale manufacture of oral dosage forms, oral medication is the most common route of administration. more widespread. About 65 percent of commercially available generic drugs are taken orally. Oral formulations account for approximately 90% of the global market share of all pharmaceutical formulations intended for human use, according to current estimates. Orally administered pharmaceuticals make up about 84 percent of the top-selling pharmaceuticals. They are the main contributor to the growth of the market due to the preferred and cheap option. Additionally, they are patient friendly, especially in geriatric and pediatric populations, and are relatively easy to create compared to their large molecule rivals.

HIGHLIGHTS OF THE STUDY

  • The oral segment of the administration route is estimated to grow at a remarkable rate and represent the largest share throughout the study period.
  • Brand-name generics dominate the generic drug market in 2020, but pure generics are expected to overtake brand-name generics by 2027.
  • The Asia-Pacific region is expected to grow at the fastest CAGR during the forecast period owing to the rapid penetration of local players in the market.
  • North America dominated the generic drug market and is expected to maintain its trend throughout the forecast period.
  • The Cardiovascular segment of Therapeutic Applications segment posted significant revenue share in the year 2020, while the Oncology segment was poised to grow at the fastest rate for the foreseeable future.
  • The retail pharmacy holds the leading position in the distribution channel segment; however, online distribution grows at a significant rate during the forecast period.

Asia Pacific region to gain ground in the global generic drug market due to lower manufacturing cost and highly skilled labor

Asia-Pacific is expected to show significant traction in the market during the forecast period. This is attributed to lower manufacturing costs and highly skilled labor in Asian countries. According to the India Brand Equity Foundation, India has the second largest number of US FDA manufacturing plants outside of the United States that are involved in the manufacture of generic drugs. In addition, the manufacturing cost is 33% lower in India than in the United States, which increases the accessibility of generics in these countries.

Global Generic Drugs Market Size And Estimates, By Region, 2021-2027 (Billions USD)

Region 2021 2024 2027 TCCA (2021-27)
North America 149.46 165.00 178.77 3.03 %
Europe 121.34 136.67 151.47 3.77 %
Asia Pacific 98.08 130.01 168.14 9.40 %
Latin America 29.99 38.88 49.36 8.66 %
Middle East and Africa 15.69 20.79 26.89 9.40 %
Total 414.56 491.35 574.63 5.59 %

Asia-Pacific has placed a strong emphasis on increasing the supply of drugs at lower prices, even if this requires purchasing from non-traditional sources, with a historically low rate of drug use. generics. Hence, emerging countries such as India and China are complementing the growth of the generics market.

In 2019, generic and biosimilar pharmaceuticals saved the U.S. healthcare system $ 313 billion, including $ 96 billion in Medicare savings and $ 48.5 billion in Medicaid savings. Generics fill 90% of prescriptions in the United States for just 20% of the cost, at a time when access to reliable, cheap, high-quality prescription drugs is more critical than ever. In 2019, the average primary co-pay for generics was $ 6.97 compared to the average primary co-pay for brand-name drugs of $ 56.32. These supporting factors are expected to drive generic drug sales over the next few years.

Browse more health industry research reports @ https://www.precedenceresearch.com/industry/healthcare

Market competitiveness and business prospects

The global generic drug market is fragmented due to the presence of several large and small companies spread across the world. The main market players are adopting new strategies to gain attractiveness on the market. The report provides in-depth competitive analysis and profiles of major market players such as Mylan NV, Abbott Laboratories, ALLERGAN, Teva Pharmaceutical Industries Ltd., Eli Lilly and Company, STADA Arzneimittel AG, GlaxoSmithKline Plc., Baxter International Inc., Pfizer Inc., Sandoz International GmbH and others. Other players operating in the value chain are AurbindoPharma, Sun Pharmaceutical Industries Ltd., Aspen Pharmacare, Fresenius Kabi Ag, Lupine, Novartis, Glenmark, Sawai, PiramalPharma Solutions, Hikma, Cipla, Dr. Reddy’s, Endo, Stada and Mallinckrod between others.

Main market segments covered:

By type of drug

By brand

By drug administration

By therapeutic application

  • Central nervous system (CNS)
  • Cardiovascular
  • Dermatology
  • Oncology
  • Respiratory
  • Others

Key distribution channel

  • Hospitals Pharmacies
  • Retail pharmacies
  • Others

By geography

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa (MEA)

Click here for See the table of contents of the full report

The study of the full report is ready | Purchase this Premium Research Report @ https://www.precedenceresearch.com/checkout/1205

You can place an order or ask any question, please feel free to contact us at [email protected] | +1 9197 992 333

About Us

Precedence Research is a global market research and consulting organization. We provide an unmatched nature of offering to our customers around the world, in all industry verticals. Precedence Research has expertise in providing in-depth market intelligence as well as market intelligence to our clients across various companies. We are obliged to serve our various clienteles present in companies of medical services, health, innovation, new generation technologies, semiconductors, chemicals, automotive, aerospace and of defense, among various companies present in the world.

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Medical products

Four Bulgarian companies sign agreements for the supply of medical products worth a total of 2.4 million euros with a local hospital

SOFIA (Bulgaria), November 8 (SeeNews) – The St. Ivan Rilski University Hospital in Sofia has awarded four local companies contracts for the supply of medical products worth a total of 4.6 million levs (2, 7 million dollars/2.4 million euros), indicated the contracting authority. .

Ecos-Medica will deliver medical products worth 2.2 million lev to the hospital, while Ka-M Medical has signed a contract worth 1.5 million lev, the hospital said on Friday. hospital in a notice to the public procurement agency.

The hospital also said it signed a contract with Sopharma Trading worth 14,536 levs and another with Blagi worth 67,675 levs,

The contracts provide for the delivery of 164 medical products for surgery, all described in detail in the technical specifications.

Active since 1993, Ecos-Medica is a distributor of endoscopic surgery equipment, sterilization consumables and autoclave systems for the treatment of biohazardous waste.

Ka-M Medical, founded in 1999, is a wholesaler of medical products and consumables, mainly ostomy systems and surgical equipment.

Founded in 2010, the main activity of Plovdiv-based Blagi is the trading of medical devices and goods, in particular surgical equipment and consumables.

Sopharma Trading is a unit of the Bulgarian drug manufacturer Sopharma.

(1 euro = 1.95583 levs)

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Medical products

Medical Products Supply Chain Weekly Review – November 2021 # 1 | Alston & Bird

Last week, the FDA granted EUA for the Pfizer-BioNTech vaccine for children aged 5 to 11. The agency also participated in the launch of the Bespoke Gene Therapy Consortium. The administration organized a global supply chain summit to strengthen cooperation and advocate for the diversification of supply chains. Please see details of these and other supply chain developments below:

  • On October 27, the FDA, the National Institutes of Health, 10 pharmaceutical companies and five nonprofits launched the Bespoke Gene Therapy Consortium (BGTC) to optimize and streamline the gene therapy development process. In particular, the BGTC will streamline regulatory requirements and processes for FDA approval of gene therapies, including the development of standardized approaches for preclinical testing (eg, toxicology studies).
  • On October 29, the FDA cleared the emergency use of the Pfizer-BioNTech vaccine for children aged 5 to 11. The authorization is for a two-dose regimen, and each dose is less than the prescribed dose for persons 12 years of age and older. The vaccine has been shown to be 90.7% effective in preventing COVID-19 in children 5 to 11 years old. Following the decision, the CDC approved the vaccine for use in this population.
  • On October 31, President Biden convened a summit with the European Union and 14 other countries to discuss transnational cooperation to strengthen supply chains. The conversation focused specifically on the diversification of the supply chain ecosystem, covering raw materials, manufacturing of intermediate and finished products, shipping, logistics, warehousing and distribution. President Biden also announced initiatives to address supply chain disruptions, including releasing stocks, funding technical assistance in Mexico and Central America, and a commitment to host future summits on the Supply Chain.
  • On November 3, the administration announced it would release a dashboard to show metrics that track progress and activity at the ports of Los Angeles and Long Beach. The dashboard will provide data on ships at berth awaiting docking, import volume in port and retail stocks. The Administration’s goal is to use the data to help stakeholders assess the health of the supply chain and foster future collaborations.
  • On November 4, the FDA released a draft guideline for industry, Content of Premarket Submissions for Device Software Functions. The guide aims to provide industry with the required information that should be included in a pre-market submission that will help the FDA assess the safety and effectiveness of software functions included in a medical device (SiMD), as well as software that functions as a medical device (SaMD). The guidelines will apply to all types of pre-market submissions, including PMA, 510 (k) and De Novo classification requests. Comments are due in 90 days.
  • The Center for Devices and Radiological Health has released its proposed list of guidance documents to be released in fiscal year 2022. The list includes its priorities (A-List) and guidance documents to be released if resources require it. allow (B-List). The CDRH will also carry out a retrospective review of the guidance documents for the years 1982, 1992, 2002 and 2012.

[View source.]

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Generic drugs

2 US Sun Pharma units to pay $ 85 million in MDL generic drugs

By Hailey Konnath (Nov 5, 2021, 10:04 p.m. EDT) – Two U.S. subsidiaries of Indian drugmaker Sun Pharma have agreed to pay a combined $ 85 million to a proposed class of direct buyer applicants under a large multidistrict dispute over the alleged price. fixing of generic drugs, the companies reportedly disclosed.

Taro Pharmaceuticals USA Inc. will pay $ 67.6 million to settle the antitrust dispute in Pennsylvania federal court, the company revealed Thursday in a filing with the United States Securities and Exchange Commission.

Taro has entered into an agreement with César Castillo LLC, FWK Holdings LLC, Rochester Drug Cooperative Inc. and KPH Healthcare Services Inc. on behalf of the putative class of all …

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Medical products

Medical Product Supply Chain Week in Review – November 4, 2021 – Food, Drugs, Healthcare, Life Sciences

United States: Medical Product Supply Chain Week in Review – November 4, 2021

To print this article, all you need to do is be registered or log in to Mondaq.com.

Last week, the FDA granted an EUA for the Pfizer-BioNTech vaccine for use in children ages 5 to 11. The agency also participated in the launch of the Bespoke Gene Therapy Consortium. The Administration hosted a global supply chain summit to strengthen cooperation and advocate for the diversification of supply chains. Please see details of these and other supply chain developments below:

  • On October 27, the FDA, the National Institutes of Health, 10 pharmaceutical companies and five nonprofit organizations spear the Bespoke Gene Therapy Consortium (BGTC) to optimize and streamline the gene therapy development process. In particular, the BGTC will streamline regulatory requirements and FDA approval processes for gene therapies, including the development of standardized approaches for preclinical testing (eg, toxicology studies).
  • On October 29, the FDA authorized emergency use of the Pfizer-BioNTech vaccine for children 5-11 years old. The clearance is for a two-dose regimen, and each dose is lower than the dose prescribed for people 12 years of age and older. The vaccine has been shown to be 90.7% effective in preventing COVID-19 in children 5 to 11 years old. Following the decision, the CDC approved the use of the vaccine in this population.
  • On October 31, President Biden tenuous a summit with the European Union and 14 additional countries to discuss transnational cooperation to strengthen supply chains. The conversation focused specifically on diversifying the supply chain ecosystem, covering raw materials, manufacturing of intermediate and finished goods, shipping, logistics, warehousing and distribution. President Biden also announced initiatives to address supply chain disruptions, including the release of inventory, funding for technical assistance to Mexico and Central America, and a commitment to host future summits. of the supply chain.
  • On November 3, the administration announcement that it will publish a dashboard to show metrics that track progress and activity at the Ports of Los Angeles and Long Beach. The dashboard will provide data on vessels in berth waiting to berth, import volume in port and retail stocks. The administration’s goal is to use the data to help stakeholders gauge the health of the supply chain and foster collaborations going forward.
  • On November 4, the FDA published Draft Industry Guidelines, Content of Pre-Release Submissions for Device Software Features. The guidelines are intended to provide industry with the required information that must be included in a premarket submission that will help the FDA evaluate the safety and effectiveness of software functions included in a medical device (SiMD), as well as software that operate as a medical device (SaMD). The guidelines will apply to all types of premarket submissions, including PMAs, 510(k), and De Novo filings. Feedback is due in 90 days.
  • Center for Devices and Radiation Health Center for Devices and Radiation Health published its proposed list of guidance documents to be released in fiscal year 2022. The list includes its priorities (A list) and guidance documents to be published as resources permit (List B). The CDRH will also conduct a retrospective review of policy documents for the years 1982, 1992, 2002 and 2012.

The content of this article is intended to provide a general guide on the subject. Specialist advice should be sought regarding your particular situation.

POPULAR ARTICLES ON: US Food, Drugs, Healthcare, Life Sciences

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Medical products

‘Huge economic blow’ as South Ayrshire medical products sites close with 75 jobs cut

Two sites of surgical wholesalers in South Ayrshire will close next year, putting 75 hardworking employees out of work.

Guardian Surgical’s facilities in Girvan and Ayr will close in 2022 with 75 jobs lost over the next four months.

The company – which produces single-use surgical drapes, gowns and tray wraps – announced this week that an internal process is underway as the company grapples with its future.

Now a spokesperson for the company has confirmed that an “extremely difficult decision” has been made due to a loss of key customers, “obstacles in the supply chain and an overall reduction in procedures. routine surgical procedures “.

Girvan’s site at Grangestone Industrial Estate on Ladywell Avenue will see 71 jobs cut while four jobs will be cut at the warehouse at Ayr’s Heathfield Industrial Estate on Whitfield Drive.

Girvan advisor Alec Clark said the news was “a real economic blow”.



Guardian Surgical sites in Girvan and Ayr to close, resulting in 75 job cuts

He said: “It’s not just people’s jobs, it’s a whole skill base that you are losing.

“What I cannot understand is that this is a profitable factory with a skilled workforce, providing quality medical items such as PPE, gowns and masks.

“For me it’s like equating it to McVitie’s factory in Glasgow when the Turkish owners closed it, even though it was a profitable factory and had its roots in Scotland.

“I think we’re in a situation here where this is where you find yourself facing the dangers of having external property and unfortunately that’s the position we find ourselves in.”

Guardian Surgical ran into trouble in April 2016, when staff received an internal memo revealing plans to cut costs by moving operations to China.

However, after a long period of consultation, the company announced in March 2017 that the jobs had been saved.



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Cllr Clark said the South Ayrshire Council’s Economics and Regeneration team are “working in the background” and will be joining Scottish Enterprise, while he also raised the issue with Elena Whitham MSP’s office.

He said: “There was a joint approach before when there was some danger; therefore it is to be reviewed.

“I think we need the direct support of the relevant Scottish government minister here.

“We have been in contact with all the relevant agencies to make sure that we are exploring any alternatives.

“Is there an alternative to continue production here under different auspices? Is there a connection with someone else? Is there a skill set that can relate to another industry – whatever that can retain the workforce, the skills. and plant assets.

“We don’t want to let a skilled workforce be abandoned. We have an asset here and that asset needs to be nurtured and developed and hopefully retained.



Councilor Alec Clark
Councilor Alec Clark

“It is a real economic blow if this is lost, not just for Girvan but the whole region.”

A spokesperson for Rocialle Healthcare said: “After a six-week consultation period, we announced today, with heavy hearts, the closure of our two Scottish sites (responsible for the Guardian Surgical product) in 2022.

“This extremely difficult decision was made due to the continued downturn in site construction and the loss of key customers the company relied on to make the site operation commercially viable.

“With supply chain obstacles and an overall reduction in routine surgical procedures, there has been a significant impact on our order intake and forecasting models.

“As a result, we unfortunately confirm the loss of exactly 75 jobs over the next four months.

“This is a very emotional time for a group of longtime, loyal and committed staff and we will continue to do our utmost to provide support and assistance as we go through this difficult transition. “

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Medical products

Medical Products Supply Chain Week Review – October 28, 2021 – Food, Medicines, Healthcare, Life Sciences

United States: Medical Products Supply Chain Weekly Review – October 28, 2021

To print this article, simply register or connect to Mondaq.com.

Over the past week, the FDA’s Vaccines and Related Biologics Advisory Committee recommended authorization of the Pfizer-BioNTech vaccine for use in children 5 to 11 years of age. The CDC has officially approved the booster dose for Moderna and J&J vaccines. President Biden met with Dr. Robert Califf for the top FDA post. Please see details of these and other supply chain developments below:

  • On October 21, the CDC director approved the Advisory Committee on Immunization Practices (ACIP) recommendations for Moderna and J&J booster doses. The move comes after both vaccines received Emergency Use Clearance (EUA) from the FDA. The indication for the Moderna booster is administration six months after the end of the initial vaccination schedule at two doses for people aged 65 years and over, people aged 18 to 64 years with risk factors for serious disease and those whose profession puts them at risk. risk of exposure. For the J&J booster, the indication is administration two months after a first vaccination for all individuals aged 18 and over. The CDC has also approved FDA clearance to mix and match dosing from different manufacturers.
  • On October 22, President Biden met with Dr. Robert Califf to discuss the possibility of leading the FDA. Califf previously served as FDA Commissioner from February 2016 to January 2017. Califf is the Donald F. Fortin MD Distinguished Professor of Cardiology at Duke University School of Medicine. He is also the founding director of the Duke Clinical Research Institute and a member of the National Academy of Medicine. No official announcement was made.
  • On October 22, the administration announced that investments had been made in the manufacturing supply chain to expand the availability and use of home COVID-19 tests, including rapid tests. More recently, the FDA cleared the Celltrion DiaTrust COVID-19 Ag Home test, which is intended for use as a home test that can be used without a prescription. The FDA has also reissued the EUA for the Quidel QuickVue At-Home OTC COVID-19 test to include home use without a prescription. The Department of Health and Social Services and the Department of Defense have awarded more than $ 500 million in contracts to companies dedicated to this effort. The Authority has pledged to invest $ 3 billion by the end of the year. To date, 419 tests and specimen collection devices have received an EUA; however, only 15 home tests were authorized.
  • On October 26, the FDA’s Vaccines and Related Biologics Advisory Committee recommended granting an EUA for Pfizer-BioNTech’s COVID-19 vaccine for children ages 5 to 11. The two-dose regimen would be a lower dose (10 micrograms per vaccine) than vaccines used in people 12 years of age and older. If the FDA changes the EUA for the vaccine, ACIP will vote on the recommendations at its meeting on November 2-3, 2021.
  • On October 27, the FDA, Health Canada and the UK Medicines and Health Products Regulatory Agency jointly published 10 Guiding Principles for the Development of Good Machine Learning Practices (GMLP). The principles are intended to lay the foundation for international collaborative organizations (such as the International Forum of Medical Device Regulators) to advance the maturation of GMLPs.

The content of this article is intended to provide a general guide on the subject. Specialist advice should be sought regarding your particular situation.

POPULAR ARTICLES ON: Food, Medicines, Health Care, Life Sciences of the United States

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Medical products

Results of medical products actions on November 2: IDXX, STE and more

The latest earnings forecast reflects a stable quarterly performance for the medical industry so far this reporting cycle. According to the industry scorecard, 25.5% of companies in the medical sector, constituting nearly 47.6% of the industry’s market capitalization, reported profits until October 27. Of these, 78.6% exceeded profit estimates and 85.7% exceeded the same for income. Profits increased 19.6% year-on-year to revenues up 12.1%.

This scoreboard reflects the stability in the United States over the gradual reopening of the economy even amid the rise of the Delta variant. However, supply chain disruptions are still significant due to international restrictions in many geographies. In addition, many parts of the international market affected by COVID are still suffering due to declining cash flow and difficult economic conditions.

Overall, the medical sector’s third-quarter profits are expected to rise 19.5% on a sales increase of 12.6%. This compares to second quarter reported profit growth of 32.1% and revenue growth of 21.3%.

Quarterly synopsis of medical products

The dynamic nature of the COVID-19 crisis is rapidly transforming the landscape of the medical products industry. Growth in the collective operations of medical product companies (within the broader medical sector) improved significantly in the second quarter, with the phasing out of restrictions. But the third quarter reporting cycle has so far shown a steep sequential decline in the core business inherited from the companies.

However, thanks to fiscal and monetary stimulus measures and the mass vaccination campaign inside and outside the country, the process of reopening the economy has never stopped. The current reporting cycle shows that hospital visits and core hospital activities slowed temporarily in July and August, but picked up sharply in September.

On the other hand, with the increase in the number of cases, manufacturers of tests, vaccines and therapeutics have seen massive market adoption of their COVID-related health care support products and services in the third quarter. trimester.

Specifically, the third quarter results for medical product inventories so far have shown a temporary decline in baseline activity compared to the second quarter. At the same time, inventories of diagnostic tests, which had seen a slowdown in demand for COVID-19 tests in the second quarter, picked up momentum in the third quarter, in line with industry trends.

Zacks’ medical products business is currently ranked in the bottom 38% (156 out of 254 industries).

Let’s take a look at four medics players who are expected to report their results on November 2.

IDEXX Laboratories, Inc. IDXX: In the third quarter, IDEXX’s Companion Animal Group (CAG) business is expected to have benefited from consistent and healthy organic revenue growth, supported by strong organic growth in recurring CAG diagnostics revenue in the United States. United and internationally. Robust growth in clinical activities in the United States is likely to have contributed to CAG Diagnostic’s recurring revenue gains in the United States. When releasing its second quarter results, the company noted 13% growth in clinical visits to the United States, with strength in the “non-wellness” and “wellness” visit categories. The CAG branch likely benefited from organic growth in revenues from CAG diagnostic instruments, as it did in the previous quarter. (Learn more: IDEXX to Report Third Quarter Revenue: What’s in the Cards?)

Zacks’ consensus estimate for third quarter earnings per share is set at $ 1.88. Revenue is expected to be $ 793.3 million.

IDEXX has the right combination of two key ingredients – a positive winning ESP and a Zacks # 3 (Hold) or better ranking – which increases the odds of a winning winning streak.

The company has + 2.77% ESP revenue and Zacks # 3 rank.

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You can see The full list of Zacks # 1 Rank (Strong Buy) stocks today here.

IDEXX Laboratories, Inc. Price and EPS Surprise

IDEXX Laboratories, Inc. price-eps-surprise | Quote IDEXX Laboratories, Inc.

STERIS plc STE: The Applied Sterilization Technologies (AST) arm of the company likely benefited from increased customer demand for medical devices in the second quarter of fiscal 2022, as it did in the previous quarter. The company expects this branch to remain strong as its major medical device customers continue to benefit from the rebound in procedures and some inventory replenishment. Additionally, demand for COVID-related products and vaccines as well as disposables for bioprocess manufacturing is expected to remain strong, which will benefit the AST arm. (Read More: STERIS to Announce Q2 Revenue: What’s in the Cards?)

Zacks’ consensus estimate for the second quarter of fiscal 2022 is set at earnings per share of $ 1.83. Revenue is expected to reach $ 1.16 billion.

The company has ESP income of 0.00% and Zacks Rank 2 (buy).

STERIS plc Price and EPS Surprise

STERIS plc Price and EPS Surprise

STERIS plc price-eps-surprise | STERIS plc quote

Henry Schein, Inc. HSIC: According to Henry Schein’s August 2021 update, the company has seen increased demand in the global dental and medical markets for the gradual reopening of practices and stable patient traffic around the world over the course of recent months, even in countries with stricter foreclosure rules. This recovery trend is expected to continue throughout the third quarter of 2021, thus increasing the company’s turnover. (Read more: What’s next for Henry Schein in third quarter results?)

Zacks’ consensus estimate for the third quarter is set at 94 cents per share. Revenue is expected to reach $ 2.94 billion.

The company has an ESP on earnings of +1.06% and a Zacks # 2 rank.

Henry Schein, Inc. Awards and EPS Surprise

Henry Schein, Inc. Awards and EPS Surprise

Henry Schein, Inc. price-eps-surprise | Quote from Henry Schein, Inc.

Omnicell OMCL: In recent months, Omnicell has benefited from the strength of its business model and its strategic positioning in the market. In the midst of the pandemic, the corporate healthcare system and retail pharmacy customers have shown greater acceptance of the fully self-contained pharmacy. As a result, demand for Omnicell’s end-to-end automation solutions has grown. The company, in August, said it was on track to meet its five-year target company goal initiated earlier this year. All of these developments are expected to have contributed significantly to the company’s revenue in the third quarter of 2021.

Zacks’ consensus estimate for third quarter earnings per share is set at 91 cents. Revenue is expected to be $ 283.8 million.

The company has an ESP on earnings of 0.00% and a Zacks # 2 rank.

Omnicell, Inc. Awards and EPS Surprise

Omnicell, Inc. Awards and EPS Surprise

Omnicell, Inc. price-eps-surprise | Omnicell Quote, Inc.

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Omnicell, Inc. (OMCL): Free Stock Analysis Report

Henry Schein, Inc. (HSIC): Free Stock Analysis Report

IDEXX Laboratories, Inc. (IDXX): Free Stock Analysis Report

STERIS plc (STE): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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