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December 2021

Prescription drugs

An order for the distribution of fake prescription drugs

MANHATTAN, Kansas (WIBW) – After the RCPD warned residents of the dangers of fake prescription drugs and fentanyl on Thursday, a man was arrested for distributing drugs on Friday.

the Riley County Police Department said officers arrested Austin Dowling, 28, of Manhattan, for distributing controlled substances that caused an overdose in April. The alleged substances – Oxycodone and Fentanyl.

RCPD shows the difference between fake and real Oxycodone(RCPD)

The RCPD said an arrest warrant was issued for Dowling during an April 2021 opioid-related overdose investigation in Manhattan.

The officer said he arrested Dowling after he was found driving near the intersection of Valleywood Dr. and Barnes Rd. And was taken into custody just before 11 a.m.

The RCPD said Dowling was arrested on warrant on two counts of distributing possession with intent to distribute a controlled substance, distribution of a controlled substance causing grievous bodily harm and two counts of using a medium. communication for a drug transaction.

Dowling was also arrested on two additional warrants for breach of probation and failure to appear. He is currently confined to Riley Co. jail with a total bond of $ 116,000.

Copyright 2021 WIBW. All rights reserved.

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Prescription drugs

2021 Prescription Drug Market Size Analysis by Major Companies and Forecast to 2028

New Jersey, United States, – Market Research Intellect has been analyzing the prescription drug technology and markets since 2018. Since then, through the analysis of company research, we have been very close to the latest research and market developments.

In addition, Market Research Intellect works closely with many clients to help them better understand technology and the market environment and develop innovation and commercialization strategies.

Market Research Intellect offers extensive expertise in analyzing the prescription drug market. We have been in this industry for 20 years and have closely followed the rise and / or fall, success and / or disappointment of many emerging technologies during this time.

This gives us a unique eye of experience when it comes to analyzing emerging technologies in electronic materials. This is very important as it helps to build a realistic market and technology roadmap that reflects the true potential of the technology based on its intrinsic characteristics and the true level of technology and business challenges it faces.

Get | Download a sample copy with table of contents, graphics and list of [email protected] https://www.marketresearchintellect.com/download-sample/?rid=202717

Further, the market revenue by region and country is provided in the Prescription Drugs report. The report’s authors also shed light on common business tactics adopted by players. The major players in the global bPrescription Drugs Market and their complete profiles are included in the report. Additionally, investment opportunities, recommendations, and current trends in the global Prescription Drug market are mapped by the report. As a result of this report, major players in the global Prescription Drugs Market will be able to make right decisions and plan their strategies accordingly to stay ahead of the game.

The competitive landscape is an essential aspect that any key player should be aware of. The report highlights the competitive scenario of the Global Prescription Drug Market to know the competition at the national and global level. The market experts also provided an overview of each major player in the global Prescription Drugs Market, taking into account key aspects such as business areas, production, and product portfolio. Further, the companies in the report are studied on the basis of key factors such as company size, market share, market growth, revenue, production volume, and profit.

The main players covered by the prescription drugs markets:

  • Pfizer
  • rock
  • Sanofi
  • Johnson & johnson
  • Merck & Co. (msd)
  • Novartis
  • Abbvie
  • Gilead Sciences
  • Glaxosmithkline (gsk)
  • Amgen
  • Astrazeneca
  • Bristol-myers Squibb
  • Eli lilly
  • Suits you
  • Bayer
  • Novo Nordisk
  • Allergan
  • Takeda
  • Boehringer Ingelheim
  • Takeda

Prescription Drugs Market Breakdown by Type:

Prescription Drugs Market Split By Application:

The Prescription Drug Market report has been separated into distinct categories such as product type, application, end user, and region. Each segment is rated on the basis of CAGR, share and growth potential. In the regional analysis, the report highlights the potential region, which is expected to generate opportunities in the global Prescription Drug Market in the coming years. This segmental analysis will surely prove to be a useful tool for the readers, stakeholders and market players to get a complete picture of the global Prescription Drugs Market and its growth potential in the coming years.

Get | Discount on purchasing this report @ https://www.marketresearchintellect.com/ask-for-discount/?rid=202717

Scope of Prescription Drugs Market Report

Report attributeDetails
Market size available for years2021 – 2028
Reference year considered2021
Historical data2015 – 2019
Forecast period2021 – 2028
Quantitative unitsRevenue in millions of USD and CAGR from 2021 to 2027
Covered segmentsTypes, applications, end users, etc.
Cover of the reportRevenue forecast, company ranking, competitive landscape, growth factors and trends
Regional scopeNorth America, Europe, Asia-Pacific, Latin America, Middle East and Africa
Scope of customizationFree customization of reports (equivalent to 8 working days for analysts) with purchase. Add or change the scope of country, region and segment.
Price and purchase optionsTake advantage of custom shopping options to meet your exact research needs. Explore purchasing options

Regional Prescription Drugs Market Analysis can be represented as follows:

Each regional Prescription Drug industry is carefully studied to understand its current and future growth scenarios. It helps the players to strengthen their position. Use market research to get a better perspective and understanding of the market and target audience and to ensure you stay ahead of the competition.

Based on geography, the global prescription drug market has segmented as follows:

    • North America includes the United States, Canada and Mexico
    • Europe includes Germany, France, UK, Italy, Spain
    • South America includes Colombia, Argentina, Nigeria and Chile
    • Asia-Pacific includes Japan, China, Korea, India, Saudi Arabia and Southeast Asia

Key questions answered in the report:

  • What is the growth potential of the prescription drug markets?
  • Which product segment will take the lion’s share?
  • Which regional market will emerge as a precursor in the years to come?
  • Which application segment will grow at a sustained rate?
  • What are the growth opportunities that could emerge in the lock washer industry in the years to come?
  • What are the main challenges that the global prescription drug markets could face in the future?
  • Who are the leading companies in the global prescription drug market?
  • What are the main trends that are positively impacting the growth of the market?
  • What are the growth strategies considered by the players to maintain their grip on the global Prescription Drugs market?

For more information or a query or a personalization before purchasing, visit @ https://www.marketresearchintellect.com/product/prescription-drugs-market-size-and-forecast/

Visualize Prescription Drug Market Using Verified Market Intelligence: –

Verified Market Intelligence is our BI platform for telling the story of this market. VMI provides in-depth predictive trends and accurate insight into over 20,000 emerging and niche markets to help you make key revenue impact decisions for a bright future. VMI provides a comprehensive overview and global competitive landscape by regions, countries and segments, as well as as key players in your market. Present your market reports and findings with built-in presentation capabilities, delivering over 70% of time and resources to investors, sales and marketing, R&D and product development. VMI supports data delivery in interactive Excel and PDF formats and provides over 15 key market indicators for your market.

Visualize the Prescription Drug Market Using VMI @ https: //www.marketresearchintellect.com/mri-intelligence/

The study thoroughly explores the profiles of the major market players and their main financial aspects. This comprehensive business analyst report is useful for all existing and new entrants when designing their business strategies. This report covers the production, revenue, market share and growth rate of the Prescription Drugs market for each key company, and covers the breakdown data (production, consumption, revenue and market share) by regions, type and. applications. Historical prescription drug distribution data from 2016 to 2020 and forecast to 2021-2029.

About us: Market research intelligence

Market Research Intellect provides syndicated and personalized research reports to clients from various industries and organizations in addition to the goal of providing personalized and in-depth research studies. range of industries, including energy, technology, manufacturing and construction, chemicals and materials, food and beverage. Etc. Our research studies help our clients make more data-driven decisions, admit push predictions, grossly capitalize on opportunities, and maximize efficiency by acting as their criminal belt to adopt accurate mention and essential without compromise. clients, we have provided expertly-behaved affirmation research facilities to over 100 Global Fortune 500 companies such as Amazon, Dell, IBM, Shell, Exxon Mobil, General Electric, Siemens, Microsoft, Sony and Hitachi.

Contact us:
Mr. Edwyne Fernandes
United States: +1 (650) -781-480
UK: +44 (753) -715-0008
APAC: +61 (488) -85-9400
US Toll Free: +1 (800) -782-1768

Website: –https://www.marketresearchintellect.com/

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Medical supplies

Dominican Red Cross donates medical supplies to the National COVID-19 Vaccination Unit

The Dominican Red Cross COVID-19 response program donated medical supplies worth twenty thousand Eastern Caribbean dollars ($ 20,000 XCD) to the National COVID-19 Vaccination Unit. This is to further support the on-going vaccination / immunization program focused on preventing and limiting the further spread of the coronavirus.

The National COVID-19 Vaccination Unit Coordinator, Dr Keevian Burnette, thanked the Dominican Red Cross for contributing items that included syringes, bandages, alcohol prep swabs, among others. Dr Burnette highlighted the enormous support the Ministry of Health has received to date from the Dominican Red Cross since the onset of the disease. He noted that partners and stakeholders like the Dominican Red Cross are making the work of the immunization unit much easier throughout the pandemic.

Speaking on behalf of the Dominican Red Cross, President Reginald Winston noted that since the onset of COVID, the Dominican Red Cross has taken its auxiliary role to the government seriously and has provided support, a education, awareness, relief supplies to help humanity throughout this unprecedented pandemic.

The donation was made at the Dominican Red Cross National Headquarters office in Goodwill on Tuesday 28e December 2021.

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Medical products

FDA clears two oral drugs for COVID-19 – Medical Products Supply Chain Weekly Review – Food, Drugs, Healthcare, Life Sciences

United States: FDA clears two oral drugs for COVID-19 – Medical products supply chain review of the week

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

Last week, the FDA cleared oral antivirals from Pfizer and Merck for the treatment of COVID-19. The Biden-Harris administration released the trucking action plan. The CDC approved the ACIP preference recommendation for the Pfizer-BioNTech and Moderna vaccine boosts. The new recommended Tris vaccine buffer leads to greater stability and does not require dilution. Please see details of these and other supply chain developments below:

  • On December 15, the FDA approved Eagle Pharmaceuticals’ Abbreviated New Drug Application (ANDA) for injection of vasopressin (20 units / ml in multidose vials), a product that has grown in demand during the COVID-pandemic. 19. The FDA said that this approval, the first approval from an ANDA for this product, represents the agency’s commitment “to facilitate access to medical products to help meet the critical needs of the American public.”
  • On December 16, the Authority released its Trucking Action Plan to help reduce supply chain disruption as part of initiatives promoted by the Chain Disruption Task Force. supply. Globally, the plan aims to implement measures to reduce barriers to the issuance of commercial driver’s licenses (CDLs); accelerate the learning of trucking; recruit veterans, especially those with previous trucking experience, into the industry; and schedule listening sessions with the current workforce to implement improvement strategies. In order to promote immediate implementation, the plan also includes specific actions for 30, 60 and 90 days to implement the objectives of the plan.
  • On December 16, the FDA approved the use of Tris buffer for the manufacture of Pfizer-BioNTech’s Comirnaty COVID-19 vaccine. This new formulation offers two key advantages to vaccinators: (1) it increases the stability of the vaccine longer at refrigerated temperatures; and (2) it does not require dilution by the supplier before use.
  • On December 16, the CDC approved the Advisory Committee on Immunization Practices (ACIP) recommendations that the Pfizer-BioNTech and Moderna vaccines are preferred for booster use over the Johnson & Johnson vaccine. ACIP met earlier today and based its decision on data including a review of efficacy and adverse events.
  • On December 17, the FDA announced that it was considering a program that would impose sterilization changes to the master file pilot program for 510 (k) approved medical devices. The change applies to the established Category B or to new sterilization methods. In addition to manufacturers in the innovation challenge, current 510 (k) holders can also participate in two previous programs where the FDA (1) has challenged manufacturers to develop new ways to develop alternatives to the ethylene oxide; and (2) reduce emissions of ethylene oxide. If changes are made to sterilization methods when ethylene oxide is used, participants can now refer to their master files instead of submitting a new 510 (k).
  • On December 20, Moderna announced that it was continuing to advance clinical trials to develop an omicron-specific vaccine for use as a booster. He also noted that the antibodies from his 50mcg and 100mcg booster doses demonstrated a 37- and 83-fold increase in antibody levels. Clinical trials of vaccines targeting both omicron and delta are underway.
  • On December 21, the Center for Devices and Radiological Health (CDRH) released a plan for how the CDRH intends to manage reviewer workload in 2022 based on the increase in the total number of submissions. In 2021, the CDRH saw an increase in medical device submissions for approval through the traditional processes, namely the PMA, 510 (k) and Q-sub processes, which it addressed through the implementation of new approaches to review, including triage of cases, reallocation of staff and resources to COVID-19 products, use of contractors and overtime. Despite these approaches, some issues related to meeting review deadlines still need to be addressed. For devices other than in vitro diagnostics, the CDRH expects to be able to comply with the review deadlines of the Medical Device User Fee Agreement (MDUFA) in 2022 despite the influx of medical products subject to review. For in vitro diagnostic products, the CDRH will also try to meet the deadlines promised by the MDUFA. Non-COVID products that were not prioritized during the pandemic will require extended review times. In addition, the pre-submission request program will be reinstated as of January 1, 2022.
  • On December 22, the FDA cleared Pfizer’s oral antiviral drug, Paxlovid, for the treatment of mild to moderate COVID-19 in adults and children 12 years of age or older (weighing 40 kg or more). This is the first oral antiviral treatment for COVID-19 to receive emergency use authorization. The clearance was based on data from the EPIC-HR trial, which demonstrated that Paxlovid significantly reduced hospitalizations and deaths from all causes in the study population compared to those randomized to receive a placebo. Paxlovid is a combination of nirmatrelvir and ritonavir – the former inhibits the replication of SARS-CoV-2 and the latter slows down the breakdown of nirmatrelvir in the body. The FDA will continue to monitor clinical trial data for the safety and effectiveness of the drug.
  • On December 23, the FDA cleared Merck’s oral antiviral drug, molnupiravir, for the treatment of mild to moderate COVID-19 in adults at high risk of progression to severe COVID-19 and for whom options for Alternative treatment to COVID-19 is not available. accessible or clinically appropriate.

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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Prescription drugs

Crackdown on the illegal sale of prescription drugs

Police have launched a crackdown on the illegal sale of “prescription drugs” by pharmacies across the state.

Acting on the instructions of the Director General of Police C. Sylendra Babu, special teams from the Narcotics Intelligence Bureau CID as well as officials from the Department of Food Safety and Drug Administration carried out surprise checks in pharmacies in several districts. The aim was to reduce the sale of these drugs without a proper prescription, especially to students and young people.

According to Mahesh Kumar Aggarwal, ADGP, Crime, action has been taken against some pharmacies in the districts of Chengalpattu, Tiruvannamalai, Thanjavur, Salem, Vellore and Tirupattur. Police and the Department of Food Safety and Drug Administration had warned pharmacy owners not to sell over-the-counter “prescription drugs”. Surprise checks would continue, he said. Mr. Aggarwal called on the public to pass on any information about the illegal sale of controlled drugs by calling the hotline 10581 or sending a message via WhatsApp to 949810581. The public can email this contribution to spnibcid @ gmail. com.

In a separate operation, the police conducted a special campaign in all neighborhoods against the sale of narcotics and psychotropic substances. During the operation, over 2,000 kg of ganja and 21 kg of heroin worth approximately 23 crore were seized and 838 accused persons arrested. Some of these suspects had sold contraband to drug addicts. The move follows instructions from Chief Minister Deputy Stalin, who briefed the Assembly on the matter and told officials at a recent meeting that strict measures should be taken to curb the sale of drugs such as ganja near educational institutions, the sources said.

Intervention force

Earlier this week, the national meeting of the Narco Coordination Center Apex Level Committee (NCORD) described drug abuse as a major national security threat that could be addressed with comprehensive coordination between central agencies. and drug control states. The meeting, which was attended by senior police officers from across the country, was asked to form a dedicated anti-narcotics task force, the sources added.

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Medical supplies

EcoMedSupply: A Leading Provider Of Environmentally Friendly Medical Supplies, Office Supplies And Foodservice In The United States

EcoMedSupply continues its mission of providing top-notch green supplies that offer high level protection and meet ASTM Level 3 mask standards with one of the highest filtrations on the market.

Protecting the environment is not the business of environmental specialists alone. All hands should be on deck to ensure that the land and its contents are preserved for continued survival and existence. There is no gain in saying that balance is getting harder and harder to achieve, but with organizations like EcoMedSupply, it is now possible to conserve land and make it suitable for habitation.

EcoMedSupply has provided environmentally friendly products, all meeting ASTM standards for high level protection. Founded by Barbara Inwald, MD, EcoMedSupply prides itself on its ability to provide customers with a wide selection of supplies while making them environmentally friendly. While other companies compromise on quality or skimp on catalog size, EcoMedSupply offers thousands of products from hundreds of vendors in an easy-to-use centralized marketplace designed for start-to-finish simplicity and convenience.

EcoMedSupply’s categories of green supplies include medical, dental, personal and skin, veterinary and pet care, office and food. Within the medical supplies category, there are exam room supplies, PPE and staff clothing, office and home care, bed pans and incontinence care, and EMS supplies. , among other articles. The dental supplies category offers supplies for all parts of the dental office, including toothbrushes and floss, HVEs, saliva ejectors, prophylaxis angles, micro-applicators, syringe tips A / W, arc trays, impression syringes, and examination room paper products.

Spas, wellness centers, and homes in need of green skin care supplies will find the best products in EcoMedSupply’s personal and skin care supplies category. Veterinarians and pets are also included in EcoMedSupply’s scope to provide environmentally friendly supplies. EcoMedSupply is undoubtedly leading the way in the conservation of natural life with its categories of food and office supplies.

In addition to this, EcoMedSupply offers an informative section on its website, educating visitors about the environmental impact on healthcare and why concerted efforts should be made to ensure that only environmentally friendly products are made and used around the world today. To join the Ensuring the Earth is Safe for Home and for Posterity course, please visit www.ecomedsupply.com and purchase one of the very affordable and environmentally friendly products available.

Media contact
Company Name: EcoMedSupply
Contact: Barbara inwald
E-mail: Send an email
Call: 415-250-5393
Country: United States
Website: http://www.ecomedsupply.com/

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Generic drugs

Generic drugs provide information to doctors, so why is Health Canada promoting pharmaceutical brand names?

Generic drug names are often long, but they can tell doctors what type of drug it is and how it works. But it is the brand names that appear first and most prominently in Health Canada documents.

Brand names are widely used when we want to refer to a specific product – an Apple computer, a Tesla car. Sometimes brand names are used so widely that they take over – we ask for a Kleenex instead of a tissue.

Drugs have two names. The brand name is the one chosen by the company that manufactures it and that company is the only one authorized to use the name. (The name proposed by the company is being reviewed by Health Canada.) Brand names are almost always short and catchy so that physicians will remember them.

Generic names are assigned globally by the World Health Organization in collaboration with national naming authorities. These names are often long, but part of the reason for this is that they tell doctors about the pharmacological properties and / or chemical structure of the drug.

The generic name of the US $ 2 million per patient new drug for spinal muscular atrophy is onasemnogene abeparvovec. The brand name is Zolgensma. Which one will physicians (and patients) retain and use? The answer is obvious.

One of the associate editors of the Canadian Medical Association Journal notes that “some brand names are created to be reassuring or promising – so-called ‘benefit-oriented’ names such as Paxil, Celebrex, and Gluconorm – while they should in fact be prescribed with great care and taking into account the potential effects of the drug on each patient.

Is using brand names the right way to talk about prescription drugs? Apparently, Health Canada thinks so. Do you want information on safety issues with a medicine? On the Canadian recall site, you will see the brand name in CAPITALS and the generic name in lower case and in parentheses.

Want to see if there is a shortage of the drug your doctor just prescribed for you? Go to Drug Shortages Canada and you will find the brand names of the drugs, again in all caps.

If you want to know why Health Canada approved a particular drug, the Basis of Approval Summary document will help you understand. But again, the brand name is the most important, and again it’s in all caps.

What’s in a name?

In medical school, students learn to use generic names. Medical journals require authors to use generic names in the articles they write. Does the name used by doctors matter? The answer is yes.

When Australian anesthesiologists and doctors trained to be anesthesiologists at two university hospitals were given the brand names of the drugs, they could only correctly identify the therapeutic group from which the drug came in just over half of the cases. Without knowing which therapeutic group the drug was from, doctors could have accidentally used another drug from the same group or they could have used the drug incorrectly.

The more money doctors received from drug companies in the form of meals, travel arrangements, and property royalties, the less likely they were to prescribe by generic name. Seeing pharmaceutical company sales representatives more frequently is associated with increased prescriptions for brand name products, resulting in more expensive prescriptions. Sales representatives also typically omit important information about the safety of the drugs they are promoting. Therefore, besides more expensive prescriptions, they can also be more likely to harm patients.

Brand names, drug regulation (the domain of Health Canada) and drug promotion came together particularly blatantly in the case of buprenorphine-naloxone, the brand name Suboxone, an opioid drug used to treat addiction. opioids.

Even though generic formulations of the drug have been available in Canada since 2013 (and even earlier in the United States), the drug is widely referred to by its brand name, including in the media, by policymakers, and by physicians.

Brand education

This happened in particular through the promotion of an “educational” program developed and implemented by Indivior, the company which owns the rights to Suboxone. In some provinces, completing this branded program is a prerequisite for prescribing buprenorphine-naloxone. The same strategy was used for a related injectable form of buprenorphine, also owned by Indivior.

This use of the branded program is the case even though there are already some very good accredited, non-industry educational programs to teach proper opioid addiction care and prescriptions to doctors, nurses and pharmacists.

The inclusion of the brand name in the title of this program is against recommended practices and accreditation standards for Canadian medical education programs.

Yet the brand-name program is fully endorsed by Health Canada through that agency’s review and approval of the Suboxone Product Monograph. This document, which describes the nature of the drug and its approved uses in Canada, includes a description of the requirement to participate in the branded “training program”.

As has been documented in the United States, Indivior and its parent company Reckitt Benckiser have engaged in various unscrupulous practices to promote their multibillion-dollar line of buprenorphine products – ultimately paying some of the largest fines in the world. pharmaceutical history of the United States. From this perspective, a branded “educational” program appears to be yet another vehicle for brand promotion, and one in which Health Canada is directly involved.

When doctors use brand names, they may be less knowledgeable about the medications they are prescribing, their prescriptions cost more, and patients may be more likely to suffer from side effects. When Health Canada prioritizes brand names over generic names, it is actively contributing to all of these issues.

Health Canada should know better and do better.

In 2018-2021, Joel Lexchin received payments for writing a dissertation in a drug side effects action for Michael F. Smith, lawyer, and a second dissertation on the role of promotion in generating orders for Goodmans LLP and Canadian Institutes of Health Research for a presentation at a workshop on conflicts of interest in clinical practice guidelines. He is currently a member of research groups that receive funding from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. It receives royalties from the University of Toronto Press and James Lorimer & Co. Ltd. for the books he wrote.

Abhimanyu Sud has received funding or has been consulted by the Canadian Institutes of Health Research, Health Canada, the Association of Faculties of Medicine of Canada, the University of Toronto, the Center for Effective Practice and the Mississauga-Halton Local Health Integration Network for research and medical education related to opioid use and drug policy.

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Medical products

FDA Approves Two Oral COVID-19 Drugs – Medical Products Supply Chain Weekly Review | Alston & Bird

Last week, the FDA cleared oral antivirals from Pfizer and Merck for the treatment of COVID-19. The Biden-Harris administration released the trucking action plan. The CDC approved the ACIP preference recommendation for the Pfizer-BioNTech and Moderna vaccine boosts. The new recommended Tris vaccine buffer leads to greater stability and does not require dilution. Please see details of these and other supply chain developments below:

  • On December 15, the FDA approved Eagle Pharmaceuticals’ Abbreviated New Drug Application (ANDA) for injection of vasopressin (20 units / ml in multidose vials), a product that has grown in demand during the COVID-pandemic. 19. The FDA said that this approval – the first approval from an ANDA for this product – represents the agency’s commitment “to facilitate access to medical products to help meet the critical needs of the American public.”
  • On December 16, the Authority released its Trucking Action Plan to help reduce supply chain disruption as part of initiatives encouraged by the Chain Disruption Task Force. supply. Globally, the plan aims to implement measures to reduce barriers to the issuance of commercial driver’s licenses (CDLs); accelerate the learning of trucking; recruit veterans, especially those with previous trucking experience, into the industry; and schedule listening sessions with the current workforce to implement improvement strategies. In order to promote immediate implementation, the plan also includes specific actions for 30, 60 and 90 days to implement the objectives of the plan.
  • On December 16, the FDA approved the use of Tris buffer for the manufacture of Pfizer-BioNTech’s Comirnaty COVID-19 vaccine. This new formulation offers two key advantages to vaccinators: (1) it increases the stability of the vaccine longer at refrigerated temperatures; and (2) it does not require dilution by the supplier before use.
  • On December 16, the CDC approved the Advisory Committee on Immunization Practices (ACIP) recommendations that the Pfizer-BioNTech and Moderna vaccines are preferred for booster use over the Johnson & Johnson vaccine. ACIP met earlier today and based its decision on data including a review of efficacy and adverse events.
  • On December 17, the FDA announced that it was considering a program that would impose sterilization changes to the master file pilot program for 510 (k) approved medical devices. The change applies to the established Category B or to new sterilization methods. In addition to manufacturers in the innovation challenge, current 510 (k) holders can also participate in two previous programs where the FDA (1) has challenged manufacturers to develop new ways to develop alternatives to it. ethylene oxide; and (2) reduce emissions of ethylene oxide. If changes are made to sterilization methods when ethylene oxide is used, participants can now refer to their master files instead of submitting a new 510 (k).
  • On December 20, Moderna announced that it was continuing to advance clinical trials to develop an omicron-specific vaccine for use as a booster. He also noted that the antibodies from his 50mcg and 100mcg booster doses demonstrated a 37- and 83-fold increase in antibody levels. Clinical trials of vaccines targeting both omicron and delta are underway.
  • On December 21, the Center for Devices and Radiological Health (CDRH) released a plan for how the CDRH intends to manage reviewer workload in 2022 based on the increase in the total number of submissions. In 2021, the CDRH saw an increase in medical device submissions for approval through the traditional processes, namely the PMA, 510 (k) and Q-sub processes, which it addressed through the implementation of new approaches to review, including triage of cases, reallocation of staff and resources to COVID-19 products, use of contractors and overtime. Despite these approaches, some issues related to meeting review deadlines still need to be resolved. For devices other than in vitro diagnostics, the CDRH expects to be able to meet the review deadlines of the Medical Device User Fee Agreement (MDUFA) in 2022 despite the influx of medical products subject to review. For in vitro diagnostic products, the CDRH will also try to meet the deadlines promised by the MDUFA. Non-COVID products that were not prioritized during the pandemic will require extended review times. In addition, the pre-submission request program will be reinstated as of January 1, 2022.
  • On December 22, the FDA cleared Pfizer’s oral antiviral drug, Paxlovid, for the treatment of mild to moderate COVID-19 in adults and children 12 years of age or older (weighing 40 kg or more). This is the first oral antiviral treatment for COVID-19 to receive emergency use authorization. The clearance was based on data from the EPIC-HR trial, which demonstrated that Paxlovid significantly reduced hospitalizations and deaths from any cause in the study population compared to those randomized to receive a placebo. Paxlovid is a combination of nirmatrelvir and ritonavir – the former inhibits the replication of SARS-CoV-2 and the latter slows down the breakdown of nirmatrelvir in the body. The FDA will continue to monitor clinical trial data for the safety and effectiveness of the drug.
  • On December 23, the FDA cleared Merck’s oral antiviral drug, molnupiravir, for the treatment of mild to moderate COVID-19 in adults at high risk of progression to severe COVID-19 and for whom options for Alternative treatment to COVID-19 is not available. accessible or clinically appropriate.

[View source.]

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Prescription drugs

Florida to become the first state to import prescription drugs from Canada

Plans to import cheaper prescription drugs from Canada have been in the works for years. In Florida, it could finally happen sooner than many realize – perhaps as early as early next year.

Florida Health Care Administration Secretary Simone Marsiller recently told a state Senate panel, “Hopefully we can start importing in the first quarter of the new year.

The fact that, while they differ in everything else, President Joe Biden and Governor Ron DeSantis both support her.

“If you have drugs in Canada, the same drug costs 25 percent of what it costs here. We want Floridians to be able to share those discounts,” DeSantis said.

A RAND study looked at drug prices in nearly 40 countries and found that the United States pays more than all prescription drugs. Average prices have risen by about 250% in the United States or, as President Biden recently noted, “about two to three times what other countries pay.”

In the United States, insurance companies cover most of the cost of drugs for those who are insured. But those without coverage and those with insurance that doesn’t cover their particular medications burn themselves or go without.

In Canada, prescription drugs are much cheaper because the Canadian government regulates and controls the prices. So the idea is to help Americans take advantage of Canada’s price controls.

As you might expect, the pharmaceutical lobby opposes plans to import prescription drugs from Canada. He ran advertisements questioning the safety of using drugs imported from other countries – an advertisement even stating: “Too many have already died from counterfeit drugs; are you willing to take that risk? “

PREVIOUS: Advertising campaign claims imported drugs are risky for Floridians

But Governor Ron DeSantis says we can trust Canada – and Congress agrees. He passed a law allowing commercial imports of drugs from Canada in 2003. Sixteen years later, Florida was one of the first states to begin the process.

The state has spent the past two years putting the system in place, which the governor says will keep it safe.

“This program only applies if we show that we are providing drugs that are safe and cheaper than what we already have,” said Governor DeSantis.

The final step is FDA clearance, and President Biden has already ordered the FDA to get to work. As soon as the FDA gives the green light, Florida plans to take action.

PREVIOUS: Florida drug import plan moves forward

Life Science Logistics in Lakeland is ready at this time. Its warehouses would start filling up with boxes and bottles of pills – all prescription drugs from Canada.

“We’re ready to start importing in 90 days,” a company spokesperson told FOX 13.

The state has not defined or announced certain details, such as which drugs will come first. State officials have suggested they could start with drugs to treat diabetes, hepatitis, COPD and / or HIV / AIDS.

They will likely start with a small number of drugs for those with Medicaid, then for others with public insurance. Further expansion would be based on the success of the program as well as demand.

There are some wrinkles in the plane that need to be addressed. The pharmaceutical industry is challenging it in court. And supplies can also be a problem, as Canada cannot supply its own citizens while having enough for the United States, or even all of Florida, for that matter. Shipments should be considered “surplus” or “surplus” in the Canadian market.

But after years of planning, Florida could overcome these hurdles in 2022, triggering big changes in where we get our drugs and how much we pay for them.

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Prescription drugs

Counterfeit prescription drugs and illicit cigarettes worth hundreds of thousands of pounds seized in Orford raid

TWO men have been arrested after police seized hundreds of thousands of pounds of counterfeit prescription drugs and illicit cigarettes following a raid in Orford, Warrington.

Over the past several months, agents from the Warrington Problem-Solving Team have conducted a detailed investigation into the illegal supply of prescription drugs in the town.

On Tuesday, December 21, the team conducted a warrant at an address in Orford where they recovered thousands of counterfeit prescription drugs, around £ 200,000 of counterfeit cigarettes and tobacco and a large amount of stolen wine and spirits .

Two local men, aged 67 and 31, were also arrested at the address on suspicion of money laundering and receiving stolen property.

The couple have since been released under investigation pending further investigation.

Sergeant Anthony Sullivan of the Warrington Problem Solving Team said: “This warrant is part of our ongoing investigation into the supply of illegal drugs.

“Illegal drugs have no place in our city; they are ruining the lives of some of the most vulnerable people in our community, while lining the pockets of shameless criminals.

“I want to reassure the public that we are doing everything we can to crack down on this type of activity.

“However, we cannot do our job without the help of the public and cannot repeat the message enough that you are essential in helping your community by reporting illegal activity to us.

“If anyone has any information about illegal drug activity or any other criminal activity taking place in your community, they should report it to Cheshire Police on 101 or www.cheshire.police.uk/tua .

“Information may also be reported anonymously, via Crimestoppers, on 0800 555 111.”

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