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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

Global Generic Drugs Industry To 2026 – North America Has Dominated Overall Market And Expected To Maintain Dominance

DUBLIN, November 09, 2021– (BUSINESS WIRE) – The report “Generic Drugs Market – Growth, Trends, COVID 19 Impact and Forecast (2021 – 2026)” has been added to ResearchAndMarkets.com offer.

The global generic drugs market is valued at around USD 263 billion in 2020 and is expected to register a revenue of USD 385 billion in 2026, with a CAGR of 6.58% over the forecast period.

Companies mentioned

  • Mylan NV

  • Abbott Laboratories

  • Abbvie (Allergan)

  • Teva Pharmaceutical Industries Limited

  • Eli Lilly and company

  • STADA Arzneimittel AG

  • GlaxoSmithKline Plc.

  • Baxter International Inc.

  • Pizer Inc.

  • Sandoz International GmbH

  • Sanofi

  • Sun Pharma

Key market trends

Injectables segment is expected to gain significant share of the studied market during the forecast period

Tablets, capsules, pills are not the only way to deliver the drug into the body, the injectable is another way to deliver the drug, and this is considered to be the most efficient way because of the bioavailability of the drug by this route is higher than the other routes. Nowadays, new advances are occurring in this segment of injectables. This way, the drug takes less time to react.

Recent developments in needleless injectors have contributed to its growth. For example, Bespak Europe Limited works closely with its biopharmaceutical partners to develop a personalized device for the needs of specific patient groups. Additionally, the prevalence of diabetes, cardiovascular issues, cancer, and several other chronic conditions will help injectables grow further during the forecast period.

Moreover, based on the application segment, Cardiovascular Drugs contribute more to generate the overall revenue of Generic Drugs, as the cases of cardiovascular diseases are increasing year by year around the world, especially heart failure, heart failure, High blood pressure, high cholesterol, angina, strokes and a few others are also involved. The increase in cardiovascular cases is due to lack of physical exercise, eating habits which mainly contain fat and sugar, other reasons are also involved. As the cardiovascular cases increase, the demand for their treatment will also increase so that the market will experience significant growth during the forecast period.

North America has dominated the overall market and is expected to retain its dominance

North America holds the maximum share of revenue generation from generic drugs. The reason for this high turnover is due to the presence of many players in the countries of North America and they continue to focus on the introduction of new products and the market as well as on the state prescription model. United, which consists mainly of brand name generic drugs. . Hence, the global generic drugs market will tend to grow here during the forecast period.

Asia Pacific has shown the fastest growing trend in the global generic market due to the increased awareness of people related to any disorder, the increase in population can also be attributed to the increase in the demand for generic drugs. Countries like India, China in Asia-Pacific contribute more than other nations.

India is the main supplier of generic drugs to the United States and European countries. According to the recent FDA report, there are around 40 major generic pharmaceutical companies in India. India has many pharmaceutical companies which manufacture a large number of generic drugs, for example Alkem Laboratories, Sun Pharma, Aurobindo Pharma Limited, several others are also present. Hence, the global generic drugs market will tend to increase during the forecast period.

Main topics covered:

1. INTRODUCTION

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS

4.1 Market overview

4.2 Market drivers

4.2.1 Growing prevalence of chronic diseases

4.2.2 Increase in the geriatric population

4.2.3 Increase in health spending

4.3 Market restrictions

4.3.1 Strict government regulations

4.3.2 Adverse drug reactions

4.4 Porter’s five forces analysis

5 MARKET SEGMENTATION

5.1 By route of administration

5.2 By application

5.3 By distribution channel

5.4 Geography

6 COMPETITIVE LANDSCAPE

6.1 Company profiles

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

For more information on this report, visit https://www.researchandmarkets.com/r/hpxgga

See the source version on businesswire.com: https://www.businesswire.com/news/home/20211109005860/en/

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