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FDA rejects Rocket Pharma’s ultra-rare immune disease gene therapy over...
The FDA rejected Rocket Pharmaceuticals’ gene therapy for leukocyte adhesion deficiency-I (LAD-I), requesting “limited additional” manufacturing information. The company announced the rejection on...
View ArticleSavara’s $100M offering; New biotech to test Eisai drug in Ph2
Plus, news about Daiichi Sankyo, Seagen, Lantheus, Life Molecular Imaging, Astellas Gene Therapies, Eli Lilly and Aparito: Savara prices $100M offering: The Langhorne, PA-based biotech will secure...
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J&J details Phase 3 success of autoimmune disease drug, touting broader range...
Johnson & Johnson’s experimental autoimmune treatment lowered the impact of myasthenia gravis on daily life compared to placebo in antibody-positive patients in a late-stage study. The drug is part...
View ArticleRovi teases acquisition offers for its CDMO unit potentially worth €2B to €3B
Rovi has attracted multiple buyout bids for its contract manufacturing business after the company said it was weighing its options for the division several months ago. The Spanish drugmaker said...
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Inside BARDA's multibillion-dollar effort to fund long-shot biotechs for Covid
In 2023, Vaxart halted work on its oral vaccine for Covid-19, and didn’t even have enough money to finish 2024. Now, the US government is lending a big hand. The Biomedical Advanced Research and...
View ArticleWhy the Supreme Court's overrule of Chevron has major implications for the FDA
The Supreme Court on Friday overruled a longstanding legal doctrine that gives federal agencies latitude to interpret federal law, which legal scholars and industry have warned could destabilize the...
View ArticleCMS spells out how states can join new cell and gene therapy access pilot
The Centers for Medicare and Medicaid Services plans to begin testing whether outcomes-based agreements might improve access to two new gene therapies approved for sickle cell disease. Cell and gene...
View ArticleFederal grand jury indicts Cassava collaborator for allegedly defrauding NIH
A Maryland federal grand jury on Thursday indicted neuroscientist Hoau-Yan Wang, a longtime Cassava Sciences collaborator, for allegedly defrauding the NIH out of about $16 million in federal grant...
View ArticleMerck calls ACIP's pneumococcal recommendation a 'missed opportunity,'...
The CDC’s Advisory Committee on Immunization Practices (ACIP) has recommended Merck’s recently approved 21-valent pneumococcal vaccine Capvaxive for adults 65 years and older, and for certain younger...
View ArticleEMA's CHMP recommends 10 new drugs as Pierre Fabre overactive bladder med...
Pierre Fabre’s overactive bladder medication won approval in Europe on Friday as a panel of experts at the European Medicines Agency separately recommended 10 others for first-time nods. The approval...
View ArticleAlnylam's big Phase 3 win; LGBTQ+ leaders charting paths; Chevron overturned;...
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add...
View ArticleUniQure sells Massachusetts manufacturing site to Genezen as it continues to...
UniQure is selling its only US manufacturing site to viral vector CDMO Genezen for $25 million, as the gene therapy biotech continues to trim operations. The Lexington, MA, site makes uniQure’s...
View ArticleCorrected: Boehringer Ingelheim, Gubra put a second candidate into the...
Boehringer Ingelheim is beginning an early-stage trial for a triple agonist candidate for obesity that it’s developing with Danish biotech Gubra. The drug, dubbed BI 3034701, will be tested in a...
View ArticleFDA says chemotherapy cisplatin is no longer in short supply
According to the FDA and a triumphant tweet from FDA Commissioner Robert Califf, the shortage of the cancer drug cisplatin that began in February of last year has been resolved. The supply issues for...
View ArticleTakeda to lay off more employees in Massachusetts
Takeda plans to let go another 220 staffers in Massachusetts, where it was the largest biopharma in 2023 with 6,290 workers. The workforce reduction impacts 189 employees in Cambridge and 31 in...
View ArticleCassava says two senior employees included in federal probes
Following years of accusations of scientific malfeasance, Alzheimer’s drug developer Cassava Sciences disclosed Monday that two of its senior employees are being investigated by the US Securities and...
View ArticleSeeking 'financial flexibility,' Esperion sells European royalty on...
Esperion has made another deal with a financial backer for an immediate cash haul in return for future revenue. Esperion received $304.7 million from the investor OMERS Life Sciences, the biotech...
View ArticleFTC investigates Teva over patents, doubling down on 'bogus' Orange Book...
The Federal Trade Commission has turned up the pressure in its patent probe, officially launching a civil investigation into a group of Teva’s drug patents that the agency claims are improperly listed...
View ArticleCartesian clears an autoimmune CAR-T trial, starts another Phase 2 and raises...
Cartesian Therapeutics, an mRNA cell therapy biotech, said its lead investigational medicine helped patients with an autoimmune condition that has caught the attention of many biopharmas in recent...
View ArticleSamsung Bio pulls in $1.06B manufacturing deal with unnamed US pharma company
Samsung Biologics has signed a manufacturing contract worth 1.46 trillion won ($1.06 billion) with an unnamed “large” US pharmaceutical company, making this at least the fourth major contract the...
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