Industry News
Biotechnology Industry News
A phase 3 trial of Belite Bio’s…
A phase 3 trial of Belite Bio’s tinlarebant in adolescents with a rare genetic eye disease has met its primary endpoint, encouraging the biotech to add the U.S. to the list of countries where it
French vaccine maker Valneva is…
French vaccine maker Valneva is closing down a site that houses both operational and R&D work, impacting 30 employee roles.
Artificial intelligence is booming…
Artificial intelligence is booming across biopharma, with deployed tech taking aim at the industry’s biggest challenges: the significant risk of failure, high costs and long development timelines.
The FDA has delayed a decision on…
The FDA has delayed a decision on Ascendis Pharma’s dwarfism drug candidate TransCon CNP, pushing back the deadline by three months to buy time to review recently submitted information.
A federal commission is warning…
A federal commission is warning that the U.S. is losing its innovative edge, arguing that the nation needs to “reimagine the federal science enterprise” by streamlining funding and incorporating AI into processes.
Protego Biopharma will use the…
Protego Biopharma will use the funding to run pivotal studies of its amyloid light-chain amyloidosis prospect PROT-001.
AbbVie is opening up submissions…
AbbVie is opening up submissions for an award that will provide one Canadian biotech free access to lab space and executive insights from the Big Pharma.
Amid a groundswell of questions…
Amid a groundswell of questions and pushback over the FDA's Commissioner's National Priority Voucher program, two lawmakers are seeking to gain more clarity.
Novo Nordisk is hitting the gas on…
Novo Nordisk is hitting the gas on amycretin development. After posting phase 2 data, the company has decided to run pivotal diabetes trials of an asset that it previously saw primarily as an obesity prospect.
A drug safety group has delivered…
A drug safety group has delivered a positive analysis for a Sarepta-licensed RNA medicine, with the same study also hitting an enrollment target. The latter development has triggered a $200 milestone payment due to Arrowhead
Swedish biotech Sprint Bioscience…
Swedish biotech Sprint Bioscience is selling off an early-stage TREX1 cancer program to Gilead for $14 million upfront, plus the chance to net up to $400 million in biobucks.
VC Versant Ventures is unveiling…
VC Versant Ventures is unveiling Dayra Therapeutics, a new biotech working on oral macrocyclic peptide drugs—a mission that has already reeled in a partnership with Biogen.
Johnson & Johnson’s attempt…
Johnson & Johnson’s attempt to develop a $5 billion-a-year Alzheimer’s disease drug has been rocked by a phase 2 flop. A scheduled data review found the anti-tau antibody posdinemab failed to significantly slow clinical decline,
Bayer’s oral FXIa inhibitor…
Bayer’s oral FXIa inhibitor asundexian has significantly reduced the risk of stroke in a phase 3 trial, giving a boost to a potentially blockbuster mechanism that has suffered setbacks over the past two years.
Hundreds of industry leaders have…
Hundreds of industry leaders have signed a letter to FDA Director Marty Makary, M.D., about the importance of having a predictable regulatory agency, citing a survey in which 82% of biopharma respondents said they were
The FDA is hiring more than 1,000…
The FDA is hiring more than 1,000 new employees and rolling out a pilot communication program in an effort to speed up the review of new drugs.
No matter who Fierce could pull…
No matter who Fierce could pull aside for a quick coffee at the conference, the general view was of a renewed sense of cautious optimism.
Nurix Therapeutics is trimming its…
Nurix Therapeutics is trimming its workforce not long after launching a pivotal phase 2 trial for its lead cancer asset.
Contineum Therapeutics’ M1…
Contineum Therapeutics’ M1 receptor antagonist has failed to move the needle in a phase 2 vision test for patients with a common form of multiple sclerosis.
Gilead’s general counsel and EVP…
Gilead’s general counsel and EVP of corporate affairs Deborah Telman will hang up the gloves by Dec. 5, the company announced in a brief filing Nov. 15. Gilead didn’t offer any explanation for Telman’s departure,