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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
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
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has begun a rolling review of Regeneron’s REGN-COV2 antibody combination (casirivimab/imdevimab) for treating and preventing COVID-19. 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