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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
Moderna has begun a much-anticipated phase 3 trial of its COVID-19 vaccine candidate mRNA-1273 — the first phase 3 trial of a coronavirus vaccine in the U.S. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) announced at its July meeting that it is reviewing trial data on dexamethasone for the treatment of COVID-19. Read More
Taro Pharmaceuticals has agreed to pay $205 million to settle charges by the Department of Justice that it conspired with other drugmakers to rig prices on various generic drugs. Read More
The Patent Trial and Appeals Board (PTAB) has dismissed claims by Moderna that a Canadian rival’s patent on lipid nanoparticle (LNP) technology is invalid, in a ruling that could have implications for Moderna’s COVID-19 vaccine candidate mRNA-1273. Read More
Drug industry representatives offered their wish lists to the FDA for reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years 2023 through 2027 in a public meeting last week. Read More