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The FDA has challenged a lawsuit filed by pharmacies against its compounding drug distribution regulations issued last year, contending it is too early to take the matter to court. Read More
An FDA expert panel on vaccines met on Friday to review strains to include in influenza vaccines for the next flu season and heard that the COVID-19 pandemic has changed the production landscape. Read More
As authorized COVID-19 vaccines are modified to protect against emerging strains of the pandemic disease, the UK will require only short clinical trials enrolling small numbers of volunteers to prove the altered vaccines are safe and effective, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said. Read More
The European Medicines Agency (EMA) has begun a rolling review of the Sputnik V COVID-19 vaccine developed by Russia’s Gamaleya Research Institute, but the European Commission doesn’t appear in a rush to secure doses. Read More
The FDA has released more meeting minutes from its talks with industry on reauthorization of the Prescription Drug User Fee Act (PDUFA), noting that there is interest in seeing the agency commit to expanding its use of real-world data in drug reviews, its capabilities for cell and gene therapy products, and other changes. Read More
The Government Accountability Office (GAO) released a new report yesterday warning the FDA about the state of its COVID-19-era inspections backlog, cautioning that the agency needs to develop alternative inspections tools and address its lack of foreign inspections as soon as possible. Read More
The FDA has laid out its plan to modernize the way it interacts with data to inform regulatory decisions like drug reviews, unveiling a three-component Data Modernization Action Plan (DMAP) on Wednesday that will begin bringing its data strategies up to date. Read More
AstraZeneca (AZ) has won a patent lawsuit in a federal court against Mylan Pharmaceuticals and Kindeva Drug Delivery, which were planning to make generic versions of AZ’s blockbuster asthma drug Symbicort (budesonide/formoterol). Read More
In March 2020, the FDA controversially granted hydroxychloroquine and chloroquine an Emergency Use Authorization (EUA), before later withdrawing the EUA. Read More
Over-the-counter drug major Perrigo said this week it is selling its generic prescription drug business to Altaris Capital Partners for $1.55 billion. The purchaser is paying $1.5 billion in cash and taking on more than $50 million in potential R&D milestone payments and contingent purchase obligations with third-party prescription partners. Read More