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Stason Pharmaceuticals did not ensure that capsules of the brain cancer drug temozolomide that it manufactured met dissolution attributes throughout their shelf life, and did not ensure proper computer security for its quality control data, the FDA said in a warning letter. Read More
Following the cancellation of a meeting yesterday at the White House to discuss drug pricing, PhRMA and BIO have come out strongly against a Trump administration executive order that would require Medicare to purchase certain drugs at the lower prices paid by other countries, arguing that the move will hurt innovation and the industry’s efforts during the COVID-19 pandemic. Read More
The U.S. Court of Appeals for the Ninth Circuit has nixed the Association for Affordable Medicines’ challenge against a California law banning pay-for-delay arrangements, finding that the generics group and its constituents did not suffer economic setbacks as a result of the legislation. Read More
Eastman Kodak has landed a $765 million government loan to manufacture drug starting materials and active pharmaceutical ingredients in the U.S. Read More
The House coronavirus subcommittee has asked the Government Accountability Office (GAO) to begin a review of the Trump administration’s Operation Warp Speed initiative. Read More
Indivior has agreed to fork over $600 million in criminal and civil penalties and have a subsidiary plead guilty to making false statements to promote its opioid addiction treatment Suboxone film. Read More
AstraZeneca is expanding its oncology product portfolio with a $6 billion development and commercialization agreement for Daiichi Sankyo’s investigational cancer treatment DS-1062. Read More
Pfizer and BioNTech began a phase 2/3 trial yesterday of one of their COVID-19 vaccine candidates, but not the one originally considered to be the most promising. Read More
Maryland-based Emergent BioSolutions has secured a $174 million contract with AstraZeneca (AZ) for large-scale manufacturing of drug substances for the UK company’s COVID-19 vaccine. Read More