FDA clears clinical trial of gene-edited pig liver used outside of body
The FDA has permitted eGenesis to begin a clinical trial of a dialysis-like system that involves using a gene-edited pig liver outside of the body. It’s the second formal study of a gene-edited pig...
View ArticleSanofi’s Kymab-originated inflammatory drug flunks mid-stage asthma trial
Sanofi’s efforts to explore its OX40-ligand targeting drug for inflammatory diseases other than eczema have hit a roadblock as the drug failed a Phase 2 trial in patients with asthma. The French...
View ArticleMural Oncology ends clinical development, lays off most workers
Boston and Dublin biotech Mural Oncology is laying off nearly all of its employees and ending clinical development of its IL-2 drug nemvaleukin alfa. The biotech flashed the red lights on Tuesday...
View ArticleBoehringer's bispecific pact with Cue Biopharma; HepaRegeniX raises €21.5M
Plus, news about MetaVia, NAYA Biosciences, Spruce Biosciences and Orion: Boehringer Ingelheim licenses bispecific for autoimmune diseases: The private pharma company will pay Cue Biopharma $12 million...
View ArticleState attorneys general urge Congress to bar PBMs from owning pharmacies
A bipartisan group of 39 state attorneys general is calling on congressional leadership to pass a bill that would prohibit PBMs from owning or operating their own pharmacies. The bipartisan letter...
View ArticleJ&J CEO chides Trump's tariff plan to boost US drugmaking
What does the biopharma industry think of President Donald Trump’s tariff plans? Just ask Joaquin Duato. The Johnson & Johnson CEO subtly but assertively criticized the Trump administration’s plans...
View ArticleBiogen, Eisai's Leqembi wins EU authorization for some patients
European regulators on Tuesday authorized the use of Biogen and Eisai’s Alzheimer’s treatment Leqembi for some early-stage patients "under strict conditions." The decision from the European Commission...
View ArticleClick Therapeutics gets FDA authorization for migraine treatment
In a sign of life for the digital therapeutics industry, Click Therapeutics has received FDA authorization for its treatment. The FDA has given marketing authorization for Click’s digital therapeutic...
View ArticleTrump pledges support for changing IRA 'pill penalty,' siding with pharma
President Donald Trump on Tuesday signed an executive order offering support for a change to the IRA's "pill penalty," one of the industry's longstanding policy priorities that could affect billions of...
View ArticleACIP meeting: CDC ‘scraping’ to respond to measles; FDA comments on Novavax
A senior CDC staffer leading the agency’s response to the measles outbreak in Texas said that it is struggling to find the resources and personnel to respond to a surge in cases that has already ...
View ArticleGeneDx to buy Fabric Genomics for up to $51M
GeneDx is slated to buy Fabric Genomics in a bid to speed up the diagnosis of genetic diseases. The diagnostic company said on Wednesday that it will pay up to $33 million in cash upon ...
View ArticleGlycomine raises $115M to target rare glycosylation disorder
A small California biotech hopes to get its rare disease drug candidate to the FDA's doorstep next year with the help of a $115 million Series C. The funding for Glycomine, disclosed Wednesday morning,...
View ArticleBiotech, CDMOs start to disclose tariff exposure with US trade inquiry underway
Many parts of the pharma supply chain could be at risk as the Commerce Department investigates the sector for potential tariffs. But even before details are ironed out, some biotechs and CDMOs ...
View ArticleAyrmid misses deadline for detailed offer to top private equity bid for bluebird
A rival bid by Ayrmid for bluebird bio hasn't crossed the finish line, the biotech said, after failing to confirm financing by a Tuesday deadline. Ayrmid sought to top a February deal between bluebird...
View ArticleEarly funding for biotechs slumps further in 2025 after several rough years
Port Therapeutics, a nimble biotech with well-known academic and executive names, went to more than 100 investors last year to move beyond the seed stage. But Port’s assets were still too far away from...
View ArticleNovartis terminates knee pain study; Telix reports brain tumor data
Plus, news about Tiger Gene and Theratechnologies: Novartis scraps knee pain drug: The Swiss drugmaker discontinued a Phase 2 test of an under-the-skin treatment for knee osteoarthritis ...
View ArticleTrump drug price executive order: Winners and losers
The biopharma industry saw its first real victory from the Trump administration's Tuesday executive order on drug pricing. The wide-ranging EO offers a first look into the new White House's drug...
View ArticleCDC advisors broaden RSV vaccine recommendations to at-risk adults in their 50s
A CDC advisory panel voted to recommend RSV vaccines for at-risk adults aged 50 to 59, a sought-after expansion by vaccine makers who are trying to grow the market. The vote from the Advisory Committee...
View ArticleCharm Therapeutics founder Laksh Aithani is out as CEO
The London biotech Charm Therapeutics is looking for a new top executive to replace founding CEO Laksh Aithani, Endpoints News has learned. Aithani co-founded the startup in 2021 at the age of 23 along...
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