Senators tell FDA that ‘greater action is needed’ to use manufacturing tech...
Sens. Marco Rubio (R-FL) and Angus King (I-ME) have told the FDA that “considerable work” needs to be done to address how advanced manufacturing technologies can be used to improve US domestic supply...
View ArticleKeytruda adds new FDA approval for a rare form of mesothelioma
Keytruda is already approved in more than 40 different oncology indications, but its latest label expansion is a first for the cancer blockbuster. Merck announced Wednesday that the FDA cleared the...
View ArticleFDA cancels Applied Therapeutics adcomm, shares skyrocket 65%
New York-based Applied Therapeutics disclosed on Wednesday that the FDA has canceled an October advisory committee meeting for its potential treatment for the genetic disorder classic galactosemia,...
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What does today's Fed rate cut mean for biotech, pharma and venture capital?
The Federal Reserve made its long-anticipated interest rate cuts on Wednesday, lowering rates by a half of a percentage point. It’s the first time the Fed has cut interest rates since March 2020, at...
View ArticleFDA approves AstraZeneca’s asthma medication Fasenra to treat rare autoimmune...
A few months after a key label expansion, AstraZeneca’s asthma treatment Fasenra has received FDA approval to treat a rare inflammatory disease. The company said Wednesday that the biologic has been...
View ArticleUpstream Bio files for IPO in sign of life for biotech public offerings
Just hours after the US Federal Reserve announced the first interest rate cut in four years, respiratory biotech Upstream Bio revealed plans for a public listing. The Boston-area biotech unveiled its...
View ArticleTang Capital’s Concentra bids for Singular Genomics days after Deerfield offer
A second buyer has made an offer to buy the DNA sequencing company Singular Genomics Systems, potentially complicating an offer made last week by the investor Deerfield Management. On Wednesday, Tang...
View ArticleStem cell startup spun out of George Church’s lab raises $75M
GC Therapeutics, a biotech startup that is writing the recipe book for turning a stem cell into nearly any natural human cell, formally launched Thursday with $75 million in financing. The startup is...
View ArticleFDA rejects Vanda’s treatment for digestion condition, company rebukes...
The FDA flashed a red light on Vanda Pharmaceuticals’ experimental treatment for a gastrointestinal condition that disrupts the digestion process. The agency rejected tradipitant in gastroparesis on...
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Sheryl Sandberg-backed Cercle raises $6M seed round with future plans to sell...
A startup that uses AI to provide insights from unstructured health data just raised a seed round, with plans to start selling its services to pharmaceutical companies in the future. Cercle uses AI to...
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Exclusive: Flagship-backed Valo Health loses interim CEO ahead of key Phase 2...
Valo Health, the well-funded computational drug discovery and development startup launched by Flagship Pioneering, lost its interim CEO less than a year after he took the role, Endpoints News has...
View Article4DMT's gene therapy reduced need for standard-of-care injections to treat...
4D Molecular Therapeutics’ one-time gene therapy reduced the need for annual injections in patients with age-related blindness in a mid-stage trial. The company on Wednesday reported updated Phase 1/2...
View ArticleAscendis aims to raise $300M; Basilea inks up to $268M deal with BARDA
Plus, news about GSK, Novo Nordisk, Tanai Therapeutics, Nomic Bio, Brenus Pharma, Xspray, Achilles Therapeutics, BioXcel Therapeutics and Nuvalent: Ascendis’ $300M offering: The Danish company...
View ArticleEdgewise’s stock surges as heart drug passes early safety test
Edgewise Therapeutics has unveiled early safety data for its rare heart disease drug, with results suggesting it could do away with a black box warning seen with Bristol Myers Squibb’s Camzyos in...
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Fertility benefits giant Progyny loses client that accounted for 13% of its...
Progyny lost a big client that made up around 670,000 members, the fertility benefits company said in a securities filing Wednesday, though analysts remain optimistic about the space. The unnamed...
View ArticleBioCentriq names ex-Resilient exec as new CEO; Sanofi, AstraZeneca boost...
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Cell therapy CDMO BioCentriq has appointed Syed Husain as its new...
View ArticleFDA inspectors discover trucks carrying torn-up records leaving Indian...
Generic drug maker Granules India has been criticized by the FDA after inspectors found three trucks full of torn-up manufacturing documents and bird droppings at one of its factories. On the first...
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Lasker Award goes to three scientists who pioneered research behind GLP-1 drugs
Three scientists whose work paved the way to the multibillion-dollar obesity drug boom have won the Lasker Award for “the discovery and development of GLP-1-based drugs that have revolutionized the...
View ArticleHouse committee advances PRV reauthorization, but timing on final passage...
The House Energy & Commerce Committee unanimously advanced a bill late Wednesday that would reauthorize the rare pediatric priority review voucher (PRV) program through 2029. But the House bill and...
View ArticleAligos’ trial for oral MASH treatment succeeds, but placebo group shows odd...
Aligos Therapeutics’ oral treatment for an advanced form of fatty liver disease reported positive results in a Phase 2 trial, showing it was effective at reducing fat across three dose levels. Despite...
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