GSK’s ‘dream appointment’ in place to succeed Emma Walmsley; Astellas...
→ GSK CEO Emma Walmsley surprised everyone this week by announcing that she’d hand the keys to commercial chief Luke Miels on Jan. 1, reasserting that “now is the right time” ...
View ArticleCidara receives BARDA award worth up to $339M for candidate that prevents flu
Cidara Therapeutics has secured an award from HHS valued at up to $339 million for onshore manufacturing and additional clinical research for its investigational antiviral biologic designed to prevent...
View ArticleOvid gets a boost from Phase 1 data, $81M+ PIPE financing
Ovid Therapeutics saw its stock jump Friday morning after it announced it would advance an epilepsy drug and revealed a new PIPE financing. Ovid shares {$OVID} rose 19% at market open on Phase 1 data ...
View ArticleRocket withdraws FDA application for rare blood disorder gene therapy
Rocket Pharmaceuticals is withdrawing its FDA application for a gene therapy for Fanconi anemia, a rare genetic disease in which the bone marrow doesn’t make enough healthy blood cells. Rocket...
View ArticleFDA OKs Zepzelca-Tecentriq combo; CSL Vifor’s layoffs
Plus, news about Egetis Therapeutics, Palisade Bio and Enanta Pharmaceuticals: 🫁 FDA approves Zepzelca-Tecentriq combo in lung cancer: Jazz and Roche each said the combination of their drugs is now...
View ArticleBridgeBio’s GondolaBio bet skirts industry’s focus on small pipelines
BridgeBio has been quietly building a sprawling pipeline at its private spinout GondolaBio. The rare disease startup launched last year with a few of BridgeBio’s rare disease assets and $300 million in...
View ArticleLegal pressure builds around FDA's new DTC pharma ad crackdown
A nonprofit with a history of beating the FDA in court on First Amendment grounds sent a stern letter to Commissioner Marty Makary this week over the agency's recent crackdown on direct-to-consumer...
View ArticleHHS reorganization suit must proceed despite government shutdown, court rules
A lawsuit over the government’s plans to reorganize the federal health agencies will proceed despite the shutdown, after a court rejected HHS Secretary Robert F. Kennedy Jr.’s request for a pause. The...
View ArticlePfizer’s ‘most favored nation’ deal; Metsera’s obesity data; Takeda stops...
Good morning, and welcome back to Endpoints Weekly! We’ve got a lot of news to recap this week, so pull up a seat and let’s get to it. Pharma reporter Max Bayer was in the ...
View ArticleTrogenix raises $95M Series A as brain cancer program nears clinic
Less than a year after leaving stealth mode, Trogenix has raised $95 million in a Series A round aimed at advancing its “Trojan horse” approach to treating cancer, starting with its lead program for...
View ArticleAstraZeneca, Daiichi Sankyo report Phase 3 win for Datroway in triple...
AstraZeneca and Daiichi Sankyo’s successor to their blockbuster drug Enhertu has cleared the first of several registrational studies in triple-negative breast cancer that could position it for a key...
View ArticleSkye’s cannabinoid drug fails in mid-stage obesity trial
Skye Bioscience’s obesity shot has failed in a mid-stage trial, adding to the evidence that cannabinoid receptor 1 inhibitors have little effect in the disease. Nimacimab, as Skye’s antibody is known,...
View ArticleArbor partners with Chiesi Group in gene editing deal
Chiesi Group is getting into CRISPR. The Italian drugmaker on Monday announced a deal with Arbor Biotechnologies to license and develop its gene editing therapy for a rare condition called primary...
View ArticleMetsera got less than it wanted from Pfizer in long-awaited obesity biotech...
Pfizer wasn’t the only pharma interested in buying Metsera, and it also didn’t pay as much as the obesity biotech’s board desired, according to new regulatory documents outlining their $4.9 billion...
View ArticleCell therapy CDMO Mytos unveils its first facility in the UK
UK-headquartered cell therapy manufacturer Mytos is launching its first CDMO facility in the country, with plans to establish another facility elsewhere in the next four years. “What's great about...
View ArticleKeeping it simple: Chen Yu steers into round three with $1.3B biotech fund
When Chen Yu unveiled the first round for his new, $800 million-plus venture fund back in the heyday of the 2021 pandemic boom, IPOs were all the rage and he styled it as a crossover ...
View ArticleNanoPhoria’s €83M Series A; AstraZeneca makes deal worth up to $555M with Algen
Plus, news about Arvinas, Alnylam, Sihuan Pharmaceutical, Neurizon Therapeutics, Nordicus Partners, and Arcutis: 🫀 NanoPhoria raises $98M Series A: The cash will fund early clinical development of the...
View ArticleAbivax releases more data from major Phase 3 wins in ulcerative colitis
Abivax fleshed out its big Phase 3 ulcerative colitis victory, presenting new analyses over the weekend of a past readout that sent its stock soaring. It assessed a pooled group of nearly 1,300...
View ArticleMary Brunkow, Fred Ramsdell, Shimon Sakaguchi win Nobel for Treg cell findings
This year's Nobel Prize in Physiology or Medicine has been awarded to Mary Brunkow, Fred Ramsdell and Shimon Sakaguchi for their discoveries about how the immune system reins itself in. ...
View ArticleFDA launches pilot program to improve US generic drug manufacturing
The FDA has revealed a new pilot program, dubbed the abbreviated new drug application (ANDA), which will encourage drugmakers to use domestic supplies of active pharmaceutical ingredients for generic...
View ArticleMid-stage health tech startups struggling to raise, report finds
Health tech fundraising has been split into two extremes of megarounds and mid-stage bottlenecks so far this year. The year has been shaped by deals of over $100 million, which have totaled $3.8...
View ArticleCDC adopts new Covid-19, chickenpox vaccine recommendations
The CDC officially adopted Covid-19, MMR and chickenpox vaccine recommendations from new advisors that HHS Secretary Robert F. Kennedy Jr. used to replace a longstanding group of public health experts....
View ArticleFDA to rework 'CERSI' university collaborations, will make funding changes
The FDA's external research conducted by universities, typically on complex public health challenges, will see a redesign in the next year, HHS confirmed to Endpoints News. The program, known as the...
View ArticleAmgen joins Trump's DTC push, will offer discounted Repatha
Amgen became the latest drugmaker to unveil a direct-to-consumer offering in response to President Donald Trump’s drug pricing push, announcing Monday that it will sell its cardiovascular medication...
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