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The FDA’s Center for Biologics Evaluation and Research (CBER) has published its list of draft and final guidances that it aims to develop in 2021. Read More
The Pharmaceutical Research and Manufacturers of America (PhRMA) is calling on the World Trade Organization (WTO) to reject a proposal that would temporarily revoke patents for COVID-19 vaccines and treatments, ahead of a WTO meeting on intellectual property scheduled for tomorrow. Read More
The federal government could invoke a clause of patent law designed for wartime to use drug companies’ intellectual property to combat the COVID-19 pandemic, says an attorney experienced in this area — while others say the same tool could help the government lower drug prices. Read More
AstraZeneca (AZ) has promised to deliver an additional 9 million doses of its vaccine to EU member states during the first quarter of this year, bringing its total delivery for the period up to 40 million — but still only half of the initial 80 million-dose commitment in its contract with the bloc. Read More
A “streamlined” process for authorizing COVID-19 vaccines modified to address significant new coronavirus strains is in the works to enable the FDA to quickly react to significant viral mutations, said Center for Biologics Evaluation and Research (CBER) Director Peter Marks. Read More
The Biden administration has moved to delay until January 2023 the implementation of a key Trump-era policy that would effectively bar pharma companies and pharmacy benefit managers (PBMs) from negotiating prescription drug rebates. Read More
The Center for Drug Evaluation and Research (CDER) is set to reorganize its Office of Generic Drugs (OGD) to help keep up with the high volume of generic drug applications. Read More
The FDA is calling for risk assessments by cell and gene therapy (CGT) manufacturers to minimize the potential for transmitting the SARS-CoV-2 virus through their products, according to a new straight-to-final guidance released yesterday. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) has released its list of planned new and revised guidances for calendar year 2021, an agenda that includes a large number of generic drug-related topics. Read More
Ventria alleges that one of its previous employees founded Wuhan Healthgen to make a plant-based albumin using techniques protected by U.S. patents that Ventria holds. Read More