Axsome reports Phase 3 depression fail for Sunosi
Axsome Therapeutics said Tuesday that a Phase 3 trial for its narcolepsy drug Sunosi failed to meet its primary goal in major depressive disorder. The company was testing Sunosi in patients who had MDD...
View ArticleZus Health CEO Jonathan Bush on the future of health records
My primary care doctor and my OB-GYN have no idea what each other did or prescribed at my last appointments with each. They rely on me to fill them in (even though they work in ...
View ArticleEuropean regulator proposal would ‘streamline’ biosimilar process
The European Medicines Agency is looking to simplify the way it approves biosimilars by removing the need for “extensive” clinical data, which would likely cut the cost of entry into the market. The...
View ArticleFDA cuts hit drug ad review office, in seeming contradiction with Kennedy's...
HHS Secretary Robert F. Kennedy Jr. has made clear that he would like to ban direct-to-consumer drug advertisements on television and elsewhere. Instead, on Tuesday, he got rid of many of the FDA...
View ArticleEli Lilly sues Empower, Strive over tirzepatide products
Eli Lilly has sued two large compounding pharmacies, alleging they deceive patients and put them at risk with compounded versions of the obesity drug tirzepatide in combinations or forms that haven’t...
View Article‘It’ll be a challenge’: BIO chief Crowley addresses seismic FDA overhaul
WASHINGTON — The size and scope of the FDA that began Tuesday won’t be the same as the day nears a brutal conclusion for agency staffers that were laid off or forced to resign. Sitting in ...
View ArticleJudge orders HHS, other agencies to 'undo' probationary worker firings
The HHS and other federal agencies must reverse the terminations of probationary government workers that were fired in the states challenging the cuts, under a new order issued late Tuesday by a...
View ArticleNew CDMO emerges, acquires cell and gene manufacturer Landmark Bio
New CDMO Artis BioSolutions has come out of stealth and is snapping up cell and gene therapy manufacturer Landmark Bio for an undisclosed amount. The new San Diego-headquartered manufacturer, which is...
View ArticleArie Belldegrun nabs two leaders for Vida Ventures amid plans for fourth fund
Arie Belldegrun's life sciences venture firm secured a pair of new managing directors after parting ways with two leaders last fall. Vida Ventures said Wednesday that it hired Matthew Cohen, most...
View ArticleEdgewise's heart drug shows promise in Phase 2 trial
Edgewise Therapeutics’ cardiac sarcomere modulator has passed a mid-stage test in patients with a genetic heart muscle disease. The biotech’s EDG-7500 produced “meaningful” reductions in left...
View ArticleAtsena raises $150M to target rare form of blindness with gene therapy
There's still money to be raised by gene therapy startups with good clinical data. On Wednesday, North Carolina biotech Atsena Therapeutics said it had raised a $150 million Series C to try and be the ...
View ArticleExclusive: Former Pfizer CSO Mikael Dolsten to advise AI unicorn Formation Bio
Can AI make an avatar of Mikael Dolsten? The former chief scientific officer of Pfizer will try to find out now that he's starting a new chapter at Formation Bio after nearly 16 years at ...
View ArticleRoche says Ocrevus failed Phase 3 study; Sanofi licenses autoimmune asset...
Plus, news about Sumitomo Pharma, Gilead, Roche, Desentum, Inhibrx and Pila Pharma: Roche's Ocrevus fails high-dose study: The Phase 3 study looking at a dose higher than the approved 600 mg of Ocrevus...
View ArticleTang Capital's Concentra nabs a win, making a deal to buy Allakos
Tang Capital's shell company Concentra Biosciences secured its first major deal since late 2023. Allakos has agreed to be acquired by Concentra for $0.33 per share in cash, and the California biotech...
View ArticleBIO CEO on tariffs, MAHA and the future of the biotech industry
John Crowley is clear-eyed about the obstacles he faces. As CEO of the trade group BIO, he’s been tasked with mounting a political comeback for an industry that has taken its punches from Democrats and...
View ArticleEli Lilly adds obesity startup knownwell to its direct-to-consumer service
Eli Lilly’s direct-to-consumer service has added another telehealth startup to its line-up of providers who can prescribe its medications, as it prepares to see more demand for obesity drugs following...
View ArticleNew FDA Commissioner Marty Makary addresses staff a day after firings
New FDA Commissioner Marty Makary took to the stage at the regulator's Maryland headquarters on Wednesday, in his first public communication to much of the agency since Tuesday's mass firings....
View ArticleFTC's fight against PBMs is paused
The FTC’s legal fight against three major pharmacy benefit managers is on hold after two agency commissioners have been removed by the Trump Administration. The commissioners, Rebecca Slaughter and...
View ArticleBiopharma execs rethink Trump impact after FDA cuts
This week’s sweeping layoffs at the FDA have caused some biopharma leaders to change their tune on the Trump administration. After President Donald Trump’s victory in November, many biopharma CEOs...
View ArticleTrump’s tariffs could leave the pharma industry scrambling
President Donald Trump on Wednesday announced broad 10% global tariffs in a move that pharma industry groups worry will upend drug costs and manufacturing. The announcement marks the administration’s...
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