Compounding association to ask for clarity around tirzepatide's shortage status
The Alliance for Pharmacy Compounding (APC) wants clarity around the FDA’s decision to reconsider tirzepatide’s removal from its national shortage list. Compounders are allowed to distribute their own...
View ArticleBavarian Nordic's mpox vaccine was safe and spurred promising immune response...
Bavarian Nordic’s mpox vaccine Jynneos generated a similar immune response in adolescents as it did in adults, offering encouraging results that suggest the shot would be similarly effective. The new...
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Sage shakes up senior management, slashes pipeline, sheds 33% of staff
After a string of mid-stage failures this year, plus a blow to its major depression commercial plans last year, Sage Therapeutics is trimming its workforce by 33%, including more than halving its...
View ArticleTerray Therapeutics raises $120M Series B for its AI ways of designing molecules
Terray Therapeutics has raised a $120 million Series B round, aiming to get its first drug candidate into the clinic while advancing in its AI-fueled approach to making molecules. Founding CEO Jacob...
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Canadian CDMO broadens CGT footprint with new $145M facility
CDMO OmniaBio on Thursday opened a commercial-stage cell manufacturing facility that has AI capabilities worth around CAD $200 million ($145 million) in its hometown of Hamilton, Ontario. Mitchel...
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Hospitals gush about new AI note-taking tools. It may leave the human medical...
When Eva Weinlander treats patients, there’s often a person in the room working as a scribe, typing away at the patient’s medical note while she focuses on providing care. But lately, Weinlander, a...
View ArticleAustralia rejects Leqembi, citing safety risks associated with the...
Australia’s regulatory agency rejected Biogen and Eisai’s Alzheimer’s drug Leqembi, noting that the drug’s efficacy doesn’t outweigh the safety risks. Australia’s Therapeutic Goods Administration (TGA)...
View ArticleParkinson's treatment from AbbVie approved after two FDA rejections
The FDA has finally approved AbbVie’s infused Parkinson’s drug for patients who don’t respond to widely used oral therapies. The drug, formerly known as ABBV-951, will be sold under the brand name...
View ArticleViatris, Lexicon ink licensing deal; Capricor’s $75M offering
Plus, news about Kezar Life Sciences and Concentra Biosciences: Viatris, Lexicon Pharmaceuticals sign licensing deal for cardio drug: Per the agreement, Viatris will pay $25 million upfront to Lexicon...
View ArticleFDA expands label for Avadel's narcolepsy drug into children
Avadel Pharmaceuticals said its once-nightly narcolepsy drug Lumryz can now be used to treat children older than 7 years of age. The Thursday approval of the supplemental NDA for Lumryz, allowing the...
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BenevolentAI CEO exits after less than a year on the job
BenevolentAI’s CEO Joerg Moeller is stepping down effective immediately, the London biotech said Thursday, in the latest leadership shakeup atop the company. Since going public in early 2022 via a...
View ArticleMerck KGaA eyes more manufacturing M&A as it faces headwinds in China
Merck KGaA said its doors are open for more M&A, particularly for its manufacturing business, as the company tempers sales expectations for its life science arm due to a muted market in China....
View ArticleEvonik winds down German site, lays off 260 workers; Chiesi’s €400M facility
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Evonik is discontinuing keto acid manufacturing at its site in Hanau,...
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RNA gene therapy startup Shape hunts for new CEO as Series C awaits
Shape Therapeutics CEO Francois Vigneault has departed the RNA gene therapy startup, and chief scientific officer David Huss is filling the post while the Seattle biotech searches for a...
View ArticleFDA delays decision on Amgen’s Lumakras in colorectal cancer
The FDA has pushed back its decision deadline to move Amgen’s KRAS inhibitor Lumakras into metastatic colorectal cancer to January, the company told Endpoints News. The regulator was supposed to decide...
View ArticleFDA finalizes guidance on generic drugs, cancer trials and neonatal drug...
The FDA on Thursday put the finishing touches on three final guidance documents focused on reviewing drug master files (DMFs) in advance of generic drug submissions, collecting patient-reported...
View ArticleHouse’s prominent China critic Jim McGovern leads opposition to Biosecure...
A Massachusetts lawmaker who frequently criticizes China has become the unlikely face of opposition to legislation that seeks to blacklist Chinese contractors like WuXi Biologics. Last month, Rep. Jim...
View ArticleSecretive Treeline Biosciences discloses $421M financing in filing
Josh Bilenker and Jeff Engelman’s secretive startup Treeline Biosciences has another $421 million, according to a new SEC filing. The funding, which closed today according to the filing, ranks as one...
View ArticleAmylyx presents full Phase 2 data for withdrawn ALS drug in another rare...
Amylyx is trying to move forward with its effort to turn its former ALS drug into a treatment for other conditions, and data released Thursday build on a small interim dataset from earlier this year...
View ArticleIntercept's liver disease drug faces full approval delay following negative...
Following a nearly unanimous adcomm against Alfasigma and Intercept Pharmaceuticals’ rare liver disease drug Ocaliva, the FDA has delayed its decision on whether to convert the drug from an accelerated...
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