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Amgen is acquiring Seattle, Wash.-based Rodeo Therapeutics in a move to broaden its reach in regenerative medicine, in a deal worth up to $721 million. Read More
The European Medicines Agency (EMA) confirmed yesterday that it has not found any causal link between blood clots and inoculation with the AstraZeneca (AZ) COVID-19 vaccine. Read More
HHS has released its latest semiannual regulatory agenda with just four planned drug-related actions by the FDA — three proposed rules and one final rule. Read More
With Pfizer/BioNTech’s COVID-19 vaccine demonstrating 100 percent efficacy in patients aged 12 to 15 years in their phase 3 trial, the companies will seek an amendment to their Emergency Use Authorization (EUA) and other regulatory authorizations to allow its use in that age group. Read More
An independent investigation has shown that uniQure’s hemophilia B gene therapy (etranacogene dezaparvovec) was not responsible for a reported case of liver cancer that led to a clinical hold by the FDA on its entire clinical development program for the gene therapy, the company said. Read More
The FDA has issued a warning letter to Tarmac Products, an over-the-counter (OTC) drugmaker in Miami Gardens, Florida, writing up the firm for incomplete testing and stability data, insufficient assay failure investigations and other violations. Read More