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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 COVID-19 vaccine Covaxin, which was approved for emergency use in India ahead of late-stage trial results, may be coming to the U.S., as its manufacturer, Bharat Biotech, has secured a U.S. partner and plans to seek Emergency Use Authorization (EUA) from the FDA for distribution in the U.S. 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
St. Petersburg, Russia-based Pharmsynthez has reportedly begun manufacturing a generic version of Gilead Sciences’ COVID-19 antiviral treatment Veklury (remdesivir) without the U.S. company’s permission. Read More
Peer-reviewed interim results from the Gamaleya Research Institute’s phase 3 vaccine trial showed that its Sputnik V vaccine was safe and nearly 92 percent effective against symptomatic coronavirus, encouraging results that line up with previous data released by Moscow researchers. Read More
The Pfizer/BioNTech vaccine may not protect against a key mutation found on the coronavirus variant identified in South Africa, B.1.351, new UK research suggests. Read More
The AstraZeneca/Oxford University COVID-19 vaccine offers sustained protection of 76 percent effectiveness for three months following an initial dose, Oxford researchers reported in early results from multiple trials in the UK, Brazil and South Africa. Read More
As the U.S. impatiently awaits delivery of many more millions of doses of the two currently authorized COVID-19 vaccines, Pfizer/BioNTech and Moderna said they are confident that they can fully deliver what’s been ordered to date in the next few months — and that they have shipped around 59.4 million doses so far. Read More
Eywa Pharma’s generic drug manufacturing facility in Cranbury, N.J., drew a Form 483 from the FDA for quality deficiencies observed during an agency inspection. Read More
Horizon Therapeutics plans to expand its rare disease therapy portfolio through the purchase of Viela Bio in a deal valued at over $3 billion. Read More