#JPM25: Day 3 at the JP Morgan Healthcare Conference
It's day 3 of the JP Morgan Healthcare Conference, and it's started to get a little less crowded in San Francisco. That said, many small biotechs, pharma companies and manufacturers are still set to...
View ArticleHinge Bio's $30M raise; Keros reports additional issues in Phase 2 PAH trial
Plus, news about Inflammasome Therapeutics, Johnson & Johnson and Verastem: Autoimmune disease startup nabs $30M: Hinge Bio de-stealthed with a Series A on Wednesday, led by hedge ...
View ArticleDrugmakers again tout limits of IRA impact
Johnson & Johnson, AstraZeneca and Pfizer leaders reiterated during the JP Morgan Healthcare Conference that the federal government’s price negotiations still won’t have a material effect on their...
View ArticleFDA explains why it rejected Vanda's stomach drug in late 2024
Rarely does the FDA publicly release its reasoning for rejecting a potential new drug. But for DC-based Vanda Pharmaceuticals' gastroparesis drug, the FDA on Wednesday spelled out why it issued a CRL
View ArticleVertex's fertility support bid is 'self-serving,' HHS says
The Department of Health and Human Services says Vertex is “grasping at straws” in a lawsuit challenging the agency’s decision to reject its proposed fertility support for certain gene therapy...
View ArticleDEA issues proposed rule to permanently expand online prescribing of...
The Drug Enforcement Administration on Wednesday issued a long-awaited proposed rule that would create a permanent process for clinicians to more easily prescribe controlled drugs online. The proposal...
View ArticleEli Lilly's Omvoh earns FDA approval for Crohn's disease
The FDA approved Eli Lilly’s Omvoh in Crohn’s disease, the company announced Wednesday, handing the drug its second indication after giving it a green light for ulcerative colitis in late 2023. While...
View ArticleVaccine patch startup Micron Biomedical adds $16M to Series A haul
Vaccine tech company Micron Biomedical has started 2025 on a positive note, raising over $16 million in a Series A extension round. The funding will be used to manufacture its vaccine “button”...
View ArticleA mixed year for deals and dollars left biotech execs hungry for a better 2025
It’s time for one last look at the biotech numbers for 2024. And you might be surprised by some bullish charts below — especially if you zero in on deal numbers and VC cash. But not ...
View ArticleFDA rejects Atara's cell therapy for rare transplant complication, stock craters
US regulators have rejected a T cell therapy for a rare and serious transplant complication related to Epstein-Barr virus from Atara Biotherapeutics and Pierre Fabre. The therapy, known as...
View ArticleDenmark’s new manufacturing learning center; Telix buys facility, assets and...
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Novo Nordisk is investing DKK 120 million ($16.5 million) into...
View ArticleBoehringer's schizophrenia asset fails Phase 3; GSK buys organoid biotech
Plus, news about Kodiak Sciences, Outlook Therapeutics and Avacta: Boehringer Ingelheim reports Phase 3 schizophrenia fail: The drug, iclepertin, did not show any “statistically significant effects on ...
View ArticleBroad Institute paper offers potential new framework for treating...
Most clinical trials for Huntington’s disease have run aground in the last few years, but academic researchers haven’t been dissuaded from trying to shift how the rare genetic disorder is understood. A...
View ArticleNovartis enters fight against HHS for denying its 340B rebate model
Novartis is the latest drugmaker to sue the government for allegedly rejecting its proposed model to distribute federal drug discounts. The lawsuit marks the fifth drugmaker to challenge HHS’ Health...
View ArticleUnitedHealth Group reports higher revenue in first earnings since Brian...
Since the killing of UnitedHealth Group’s top insurance executive and the outpouring of public frustration with delayed and denied care that followed, a major question has circled the healthcare giant:...
View ArticleIs digital health living up to its promise?
A central aspiration of health tech is that technology will make getting care easier and less expensive, allowing for more people (and especially disadvantaged people) to use it. But new research...
View ArticleEMA in 2024 recommended highest number of drug approvals in 15 years
The EMA's human medicines committee recommended 114 medicines for approval in 2024, marking the highest number of positive opinions issued in 15 years, according to the regulator’s latest report. Of...
View ArticleDC appeals court halts launch of generic to Novartis' heart drug
Novartis won a potentially short-lived victory in its fight across multiple courts to keep generic versions of its blockbuster heart drug Entresto off the market. The US Court of Appeals for the DC...
View ArticleShionogi lands $375M from HHS to develop preventive drug for Covid-19
After seeing its Covid-19 drug fail in a Phase 3 trial last year, Shionogi on Thursday won a $375 million award from HHS to develop a preventive drug for the disease. The drug is aimed ...
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