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Atara will receive an initial $60 million from Bayer and is eligible to receive an additional $610 million and tiered royalties in milestone-based payments. Read More
With FDA emergency authorization seeming very likely for Pfizer’s COVID-19 vaccine within days, all 50 states and U.S. territories have finalized their individual “microplans” for distribution and administration, according to an Operation Warp Speed official. Read More
Yesterday, Pfizer and BioNTech disclosed that information pertaining to their regulatory submission for emergency-use approval of COVID-19 vaccine BNT162b2 was hacked on a European Medicines Agency (EMA) server containing the data. Read More
Both the EU and Japan have forged larger initial supply deals for Pfizer’s COVID-19 vaccine than the U.S. government, which is in the hot seat for declining to order additional vaccine doses, and it appears Pfizer will have to honor its deals with other countries before it can provide more to the U.S., though the government disputes that. Read More
A cystic fibrosis (CF) advocacy group has levied a formal complaint with the United Nations (UN), charging that Vertex Pharmaceuticals is violating the world body’s guidelines by unfairly pricing its CF drugs and not ensuring widespread equitable access. Read More
Distribution plans for the Pfizer-BioNTech COVID-19 vaccine in the U.S. remain an enormous question mark as an initial roll-out of mass vaccination gets under way in the UK. Read More
Beckton Dickinson (BD) has announced that it is investing $1.2 billion over four years toward strengthening its manufacturing capabilities for future pandemic responses and injectable drug and vaccine innovation. Read More
The decision was made “to respond to 340B program abuses arising from the excessive expansion of contract pharmacies,” a Novo Nordisk spokesperson said. Read More
Warnings of international crime targeting the yet-to-be-approved COVID-19 vaccines are getting louder, with the international police agency Interpol last week issuing an Orange Notice, which warns of an “imminent threat to public safety.” Read More
INO-4800 is currently undergoing a phase 2 study in the U.S., with the company having received a $71 million award from the Department of Defense to support clinical development of the vaccine and manufacture of its vaccine-administering smart device. Read More