Pfizer
NEWS
Despite increasing antitrust scrutiny across the biopharma industry, the European Commission on Thursday said it found no competitive issues with Pfizer’s buyout of the antibody-drug conjugate company.
The regulator approved the combination of Pfizer’s Braftovi and Mektovi for the treatment of metastatic non-small cell lung cancer in adult patients with a BRAF V600E mutation.
A revised Paxlovid supply agreement with the U.S. government has pushed Pfizer to launch a “cost realignment” program including layoffs, though it is still unclear how many employees will be affected.
The regulator’s approval of oral, once-daily etrasimod, to be marketed as Velsipity, was based on favorable Phase III safety and efficacy data showing significant clinical remission of ulcerative colitis.
The consent agreement struck between the FTC and Amgen and Horizon Therapeutics could have significant implications for ongoing and future M&A challenges, experts told BioSpace.
The regulator Monday approved the companies’ supplemental Biologics License Applications for their respective mRNA shots formulated to more closely target currently circulating variants.
In the latest salvo, Pfizer and BioNTech fired back at Moderna and asked the U.S. Patent and Trademark Office to invalidate patent claims over the COVID-19 vaccines they say are overly broad.
A second trial shows Novo Nordisk’s Wegovy improves heart health. Meanwhile, many other drugs are beginning to face generic competition, including from newly approved biosimilars.
The FDA on Monday gave the greenlight to Pfizer’s RSV vaccine for expectant mothers, given during the third trimester of pregnancy, designed to protect newborn babies through the first six months of life.
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