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In observance of the holiday season, Drug Industry Daily will not be published Thursday, Dec. 31 or Friday, Jan. 1. The next issue will be published Monday, Jan. 4. Read More
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) appears ready to authorize AstraZeneca’s (AZ) and Oxford University’s COVID-19 vaccine as soon as this week, a move that could help lighten the load on Pfizer/BioNTech vaccinations as the country scrambles to deal with a new, mutated strain of coronavirus. Read More
Novavax has launched a phase 3 study in the U.S. and Mexico to evaluate its COVID-19 vaccine candidate, NVX-CoV2373, after deferring the trial for two months because of holdups in securing doses. Read More
Santa Fe, Calif.-based over-the-counter (OTC) drugmaker Creative Essences drew a lengthy Form 483 report with eleven observations following an FDA inspection of its facility in late August and early September. Read More
Pfizer is expanding further into oncology thanks to a deal with Myovant Sciences, under which the two companies will cooperate on developing and commercializing Myovant’s newly approved prostate cancer drug Orgovyx (relugolix). Myovant will receive up to $4.2 billion, including an upfront payment of $650 million. Read More
The president’s controversial “most favored nation” strategy for lowering U.S. drug prices has been placed on hold by a federal judge pending an evaluation of its legality. Read More
President Trump signed Congress’ combined appropriations and COVID-19 relief package late on Sunday, averting a looming federal government shutdown. Read More