FDA
The FDA has three regulatory milestones in the next two weeks, including a decision on a subcutaneous formulation of an effective multiple sclerosis therapy.
J&J gained rights to the FcRn blocker nipocalimab when it acquired Momenta Pharmaceuticals in August 2020 for $6.5 billion.
Emergent BioSolutions joins Bavarian Nordic on pharma’s frontline in the fight against the ongoing mpox emergency.
The regulator’s restrictions come as the U.S. is experiencing a surge in cases. Invivyd also announced updated Phase III data for Pemgarda, touting an 84% relative reduction in symptomatic COVID-19.
Not all licensing deals are successful. Here, BioSpace examines a few noteworthy assets that Big Pharma returned in the last 12 months.
With the FDA’s rejection of Ordspono in March, Monday’s green light from the European Commission marks the first approval worldwide and the first regulatory victory for Regeneron’s bispecific antibody platform.
The regulator on Thursday said the mRNA vaccines, Pfizer-BioNTech’s Comirnaty and Moderna’s Spikevax, will better protect against currently circulating variants as COVID continues to surge in many parts of the U.S.
The Oncologic Drugs Advisory Committee in a Sept. 26 meeting will discuss whether the regulator should restrict approval of checkpoint inhibitors based on PD-L1 expression levels.
While approved by the Medicines and Healthcare products Regulatory Agency, the Alzheimer’s drug failed to win the backing of the U.K.’s National Institute for Health and Care Excellence, which said that its benefits were “too small to justify the cost.”
The regulator’s Complete Response Letter flagged problems at a third-party fill/finish site, which Regeneron says it has already addressed. The manufacturing facility is currently awaiting reinspection.
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