House panel advances bill to allow Medicare to cover obesity drugs
The House Ways and Means Committee on Thursday cleared a bill that would direct Medicare to cover obesity treatments — but only for a small sliver of beneficiaries. The committee voted 36-4 to pass an...
View ArticleClik here to view.
Lykos takes another hit as ICER lays out 'insufficient' evidence for...
A key independent drug pricing organization has concluded that the available evidence for Lykos Therapeutics’ MDMA-assisted psychotherapy is “insufficient” and it can’t be compared to other...
View ArticleImmunology biotech Alumis secures $250M in shrunken IPO
Alumis, an immunology drug developer on the cusp of Phase 3, will go public Friday in a smaller IPO than it originally projected. The Bay Area startup sold 13.12 million shares $ALMS at $16 apiece to...
View ArticleClik here to view.
Autoimmune brain disease startup Arialys gets new leader; Intellia, Arvinas...
Peter Flynn Peter Flynn has taken the helm from Avalon BioVentures managing partner Jay Lichter at Arialys Therapeutics, a startup that is developing treatments in the field of immunoneuropsychiatry —...
View ArticleClik here to view.
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...
View ArticleClik here to view.
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...
View ArticleClik here to view.
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 Article