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In a 12-2 vote with two abstentions, the advisers said the benefits did not outweigh the risks.
The Phase III trial met its primary endpoint, a significant reduction of phenylalanine levels in the blood, with no severe adverse events reported, PTC Therapeutics reported Wednesday.
Fenebrutinib in a mid-phase trial reduced brain legions in relapsing forms of multiple sclerosis, the company reported. It is the only reversible BTK inhibitor currently in Phase III MS trials.
In the heart of one of the most innovative hubs in the country, biotech jobs in San Francisco abound, providing ample opportunity for job seekers.
Athenex announced it will lay off 79 employees in Buffalo and 44 employees in Clarence as a result of the Chapter 11 filing.
The $75 million deal will leverage Scribe’s CRISPR technologies to develop gene therapies for neurological and neuromuscular disorders. Scribe previously struck deals with Biogen and Sanofi.
Less than two years after announcing the launch of its clinical trial services business, CVS Health reported that it will shut down the division by the end of 2024.
The Federal Trade Commission filed a lawsuit Tuesday seeking an injunction to prevent Amgen’s buyout of Horizon Therapeutics, which the agency says would “entrench monopoly drugs.”
Results from Phase IIb VOYAGE study showed Viking’s oral thyroid beta receptor agonist cut liver fat content by up to 51% in confirmed non-alcoholic steatohepatitis patients.
A collaborative research agreement will leverage Sony’s unique polymer, which the companies contend is a stable, effective linker for delivering antibody-drug conjugate payloads to cancer cells.
The U.S. Supreme Court’s denial of Teva Pharmaceuticals’ appeal could have broad ramifications for the wider generics industry, for which “skinny labeling” is a common and accepted practice.
Two new developments for lab and office space are expected to add over 2,000 acres of space in Atlanta to accommodate the life science industry’s rapid growth.