Pharma’s IRA fight persists as it looks to Supreme Court, lobbies for changes
The government has so far prevailed about a dozen times in legal challenges against Medicare’s drug price negotiation program. But the fight isn’t over. Since March 2024, federal courts across at least...
View ArticleStephen Hahn steps down as CEO of Flagship biotech; A new era at AbbVie...
→ Former FDA Commissioner Stephen Hahn has handed the reins to board member Ajit Singh at Flagship’s early cancer detection biotech Harbinger Health. Hahn was named CEO of ...
View ArticleWhich large pharma might make the next move in the VEGF bispecific race?
Summit Therapeutics licensed its PD-1xVEGF bispecific antibody ivonescimab from the Chinese company Akeso back in 2022. But analysts believe that the US biotech needs to find another, even bigger...
View ArticleNeurizon cites ‘strain’ at FDA as reason for delay on IND hold; Fifty Years’...
Plus, news about Vyne Therapeutics, Prelude Therapeutics, Bausch Health and Minerva Neurosciences: 🏛️ Neurizon Therapeutics says FDA delayed IND decision: The biotech is still waiting to see if the...
View ArticlePrecigen’s rare disease therapy gets full approval from the FDA
The FDA granted an unexpected full approval to Precigen's treatment for a rare disease caused by human papillomavirus, or HPV. Thursday's decision also came earlier than anticipated, at a time when the...
View ArticlePfizer's sickle cell drug candidate fails Phase 3 trial
A sickle cell candidate from Pfizer’s $5.4 billion acquisition of Global Blood Therapeutics failed a Phase 3 study, the pharma giant announced on Friday. Inclacumab didn’t significantly reduce the rate...
View ArticleKennedy rejects reports of 2028 run, defends top aide
HHS Secretary Robert F. Kennedy Jr. on Friday shut down rumors that he was in the early stages of another presidential campaign, writing on social media that "I am not running for president in 2028" ...
View ArticleGene therapy startup Kriya Therapeutics gets $313M
Kriya Therapeutics, a North Carolina and California biotech, reeled in a $313 million funding round, according to an SEC filing on Friday afternoon. The gene therapy startup is developing treatments...
View ArticleBayer bets big on KRAS inhibitor; Treg biotech shuts down; Novartis touts...
Welcome back to Endpoints Weekly! We’ve got a lot to recap this week, so let’s get right to it. Bayer reached a deal worth up to $1.3 billion for the rights to a KRAS G12D ...
View ArticleAnocca gets $46M to run early TCR cell therapy clinical trial
Anocca announced Monday that it secured a fresh SEK 440 million — or roughly $46 million — to run an early-stage trial of a cell therapy for KRAS mutant pancreatic cancer. The Swedish biotech started...
View ArticleNovo Nordisk’s Wegovy is the second drug approved in MASH
After securing an accelerated approval, Novo Nordisk’s Wegovy is the second drug to receive a green light in the US to treat fatty liver disease, or MASH. The blockbuster drug will ...
View ArticleUpdated: Reunion’s psychedelic approach in postpartum depression clears Phase...
Reunion Neuroscience has reported a mid-stage success with its short-acting psychedelic drug in postpartum depression (PPD), paving the way for the company to initiate a registrational trial next year....
View ArticleSkyhawk's RNA mission gets another $2B lift via Merck KGaA
While its aircraft namesake is a single-seater carrier, Skyhawk Therapeutics does not ride solo. As of Monday morning, Merck KGaA became its ninth pharma company co-pilot through an RNA-targeting small...
View ArticleGoodRx, Novo Nordisk partner to offer discounted GLP-1s at the pharmacy counter
GoodRx users will now be able to get all strengths of Ozempic and Wegovy injections at a cash price of $499 per month, thanks to a new collaboration between the prescription drug discount company and ...
View ArticleStealth resubmits ultra-rare disease drug to FDA; Boehringer's retinal deal
Plus, news about SRT Therapeutics, Precigen, Enlivex, Tonix Pharmaceuticals and LakeShore Biopharma: Stealth BioTherapeutics resubmits its rare drug to the FDA: The privately held biotech’s...
View ArticleConflicts among US vaccine advisors declined through 2024, new research shows
New research found that self-reported conflicts of interest among federal vaccine advisory members were at their lowest level in 25 years through 2024, countering an argument of politically-appointed...
View ArticleGenentech ends up to $2B cell therapy collab with Adaptive
Roche's Genentech has terminated a cell therapy partnership with Adaptive Biotechnologies, ending what could have been a $2 billion deal for the Seattle biotech. The duo worked together for more than...
View ArticleHow the draft MAHA Commission recommendations may impact pharma
The White House’s MAHA Commission report includes a broad vaccine framework that will address the childhood vaccination schedule and injuries, according to a draft version cited by other media outlets...
View ArticleFederal appeals court sends Vanda’s jet lag case back to FDA
Vanda Pharmaceuticals’ jet lag treatment appears to be headed back to the FDA following what the company is calling a “landmark victory” in a federal appeals court. The US Court of Appeals for the DC ...
View ArticleFDA delays decision on Regenxbio’s Hunter syndrome gene therapy by three months
It may take the FDA three months longer than expected to decide whether to approve Regenxbio’s gene therapy for a rare disease called Hunter syndrome, the company announced Monday evening. The agency...
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