Regulatory
$27.8B Amgen-Horizon deal gets FTC clearance with restrictions; the White House names first 10 drugs subject to Medicare price negotiations; Sage Therapeutics axes 40% of staff.
After shoring up quality control at its Reykjavik manufacturing facility, the biotech has resubmitted a BLA to the FDA seeking an interchangeability designation for its Humira biosimilar.
However, a lack of regulatory harmonization risks undermining the effective implementation of these technology-driven approaches.
Citing lack of evidence and manufacturing issues, the regulator has rejected Outlook Therapeutics’ bid to have its bevacizumab formulation approved for wet age-related macular degeneration.
The Biden administration on Tuesday released a much-anticipated list of the first 10 medicines included in Medicare’s Drug Price Negotiation Program under the Inflation Reduction Act.
Following a countersuit by Amgen and Horizon Therapeutics, the Federal Trade Commission has temporarily suspended its challenge to the multi-billion dollar merger between the two companies.
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.
In the next two weeks, the FDA will hand out regulatory verdicts to BMS, Outlook Therapeutics and BioLineRx.
The biotech’s experimental vaccine has shown a neutralizing response to XBB sublineages of COVID-19, which currently dominate new cases in the U.S. and Europe.
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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