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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 ArticleArtiva refiles for IPO three years after original plans in a vastly different...
Artiva Biotherapeutics, a clinical-stage NK cell therapy biotech, is trying again for the public markets, it revealed Friday afternoon in an SEC filing. The San Diego biotech is going for a Nasdaq...
View Article#EAN24: Dianthus teases preclinical data for autoimmune drug as it starts...
Dianthus Therapeutics has unveiled in vitro results of its drug candidate in a pair of autoimmune disease models, supporting recent efforts to start mid-stage studies. The first dataset from the blood...
View ArticleEisai takes over development of ADC after Bristol Myers ends $650M collaboration
Due to Bristol Myers Squibb’s portfolio prioritization efforts, Eisai is taking back an antibody-drug conjugate that they originally teamed up on in 2021. Eisai will now develop and commercialize the...
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Aerovate plans to lay off nearly all employees after trial failure
Aerovate Therapeutics plans to lay off nearly all its employees two weeks after its lead asset flunked a mid-stage trial. The company disclosed the workforce reduction on Friday evening in an SEC...
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Lilly inks radiopharma deal with Radionetics, with rights to buy the biotech
Eli Lilly is further delving into the radiopharmaceutical field with a $140 million upfront deal with Radionetics Oncology. The strategic pact with the San Diego biotech could turn into a $1 billion...
View ArticleTracon to seek ‘strategic’ options; Ovid to lay off 17 workers
Plus, news about Merck, Orion, Tonix, Freeflow and Y-mAbs Therapeutics: Tracon Pharmaceuticals seeks ‘strategic alternatives’ after PD-L1 fails Ph2 trial: In an 82-person sarcoma study, only four...
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...
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