Archive for December 2021
Moderna Pauses Acrimonious Bid for Patent on mRNA Sequence, Says More Time is Needed for Discussions with NIH
Amid an ongoing dispute with the National Institutes of Health (NIH) over who exactly invented the mRNA sequence of Moderna’s COVID-19 vaccine, the company is hitting the pause button on pursuing a patent for the sequence. Source: Drug Industry Daily
Read MoreFDA to Resume Unannounced Foreign Inspections Shortly, Says FDA Official
The FDA plans to resume unannounced onsite inspections in India and China shortly after the New Year. Source: Drug Industry Daily
Read MoreFDA Puts Another Hold on Bluebird’s Sickle Cell Gene Therapy
The FDA has placed a partial clinical hold on Bluebird Bio’s gene therapy for sickle cell disease (SCD), lovotibeglogene autotemcel (lovo-cel), for trial participants under the age of 18 after a volunteer contracted persistent anemia. Source: Drug Industry Daily
Read MoreAbbVie Presses Trade Commission to Ban Alvotech's Humira Biosimilar in the U.S.
AbbVie is pushing the International Trade Commission (ITC) to prevent Iceland-based biosimilar developer Alvotech from marketing its biosimilar candidate to AbbVie’s blockbuster Humira (adalimumab). Source: Drug Industry Daily
Read MoreBiogen Cuts Aduhelm Cost by 50 Percent, Hoping to Secure Insurance Coverage
In an unusual bid to trim costs and win prescriber and payer support, Biogen has cut the price of Aduhelm in half. Source: Drug Industry Daily
Read MoreFDA’s Fall Regulatory Agenda Adds Several New Proposed and Final Rules
The FDA’s fall 2021 regulatory agenda includes several new proposed and final rules. Source: Drug Industry Daily
Read MoreFederal Judge Overturns Purdue Pharma’s $4.5 Billion Bankruptcy Settlement Over Sackler Family Immunity Provision
A federal judge has overturned a $4.5 billion settlement that protected members of the Sackler family, owners of Purdue Pharma, the maker of OxyContin. Source: Drug Industry Daily
Read MoreFDA Says It Will Sic the FTC on Endo for Attempts to Block Generic Versions of Its Drug
The FDA has called out Endo International, maker of Vasostrict, saying the agency plans to ask the Federal Trade Commission (FTC) to investigate Endo for “anticompetitive business practices” after the company pressed FDA to block generics of its best-selling drug. Source: Drug Industry Daily
Read MoreWhite House and Senate Democrats to Fight for Build Back Better Vote in New Year
In what could turn out to be a fatal blow for the nearly $2 trillion Build Back Better spending package that included drug pricing reform provisions, Sen. Joe Manchin (D-W.Va.) said Sunday that he definitely will not vote for the landmark legislation. Source: Drug Industry Daily
Read MoreAstraZeneca, Regeneron Say Their COVID-19 Antibodies Treatments Still Work on Omicron
Regeneron and AstraZeneca both say their therapeutic antibody cocktails remain active against Omicron, but questions remain in light of a Chinese study concluding that the variant escapes 85 percent of tested antibodies. Source: Drug Industry Daily
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