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FDA leaders kick off rare disease hub to increase cross-center collaboration
FDA officials, including the directors of CBER and CDER, on Wednesday launched a rare disease innovation hub at a public meeting, with an aim to better collaborate and communicate across the two...
View ArticleFirst clinical test of RNA editing restores missing protein in genetic...
An experimental therapy designed to change a single letter of short-lived mRNA molecules has corrected a genetic mutation that prevents people from making a vital protein, Wave Life Sciences announced...
View ArticleCompounding 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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Sanofi invests in new radioligand partner Orano Med, buying 16% stake for €300M
A month after making a foray into the bustling radioligand field, Sanofi is further allying itself with Orano Med, paying €300 million for a 16% stake in the alpha-focused radiopharma company. Last...
View ArticleNovartis pays $70M upfront on licensing deal for Chengdu Baiyu’s antitumor drug
Novartis is spending $70 million upfront on a small molecule antitumor drug from the Chinese biotech Chengdu Baiyu. The Swiss drugmaker will get an exclusive global license for the development and...
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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...
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...
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