Liquidia sues FDA over exclusivity decision to delay Yutrepia's full approval
Liquidia has filed a lawsuit against the FDA over its decision to grant three years of exclusivity to United Therapeutics’ drug Tyvaso, which competes against Liquidia’s Yutrepia, the company announced...
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FDA closes the door on Intarcia's eight-year bid for diabetes drug-device combo
The FDA on Thursday issued an order denying Intarcia’s appeal over its rejected type 2 diabetes combo product, ending nearly eight years of back-and-forth on the application. Intarcia received complete...
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FDA approves reformulated Covid boosters for fall season
The FDA cleared a new round of Covid-19 boosters from Moderna and Pfizer/BioNTech that this time target the KP.2 variant. The updated vaccines are expected to be available in the coming days, Moderna...
View ArticleAutoimmune biotech Zenas files for IPO amid summer lull for public debuts
Zenas BioPharma filed for an initial public offering on Thursday, marking a rare move for biotech startups this summer. The late-stage autoimmune biotech follows only a few other drug developers to...
View ArticleFDA to host adcomm on PD-L1 as a predictive biomarker for checkpoint inhibitors
The FDA is assembling its Oncologic Drugs Advisory Committee next month to discuss whether a biomarker should be used to select patients with certain stomach and esophageal cancers for treatment with...
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Oncology biotech Bicara unveils IPO pitch same day as Zenas
For a while, there were none. Suddenly, there were two. Bicara Therapeutics filed Thursday afternoon for an initial public offering, just a few hours after fellow Boston-area drug developer Zenas...
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Gene insertion startup Tome Biosciences stops lab work as CEO shifts focus to...
Tome Biosciences, a high-profile gene editing startup spun out of MIT, is halting its lab work and looking to sell itself or find a partner to continue developing its technology, CEO Rahul Kakkar told...
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Genmab makes two C-suite additions as COO leaves; James Sabry leads a...
Anthony Mancini → There are substantial leadership changes at Genmab, starting with the departure of COO Anthony Mancini. Peer Review covered Mancini’s appointment in March 2020 following a 24-year...
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Jazz will still file anti-seizure med Epidiolex in Japan despite trial setback
Jazz Pharmaceuticals’ oral cannabidiol drug Epidiolex has disappointed in a late-phase test in Japanese children with seizures, but the company will still file there based on its global dataset....
View ArticleNovo's innovation hub expands to Bay Area; SIGA's new Tpoxx order
Novo Nordisk’s Bio Innovation Hub goes west: The Danish pharma’s early-stage R&D unit is partnering with MBC BioLabs, an incubator in the San Francisco Bay Area that has helped launch more than 300...
View ArticleCDER chief says 'standards have not changed,' explaining increase in CRLs for...
The FDA initially rejected nearly half of all biologics applications received last year, many for quality-related CMC issues that need to be improved upon, according to CDER Director Patrizia...
View ArticleJ&J grants 'short extension' for certification of talc settlement vote
Talc claimants will have to wait a bit longer for the results of a vote on J&J’s proposed $6.5 billion settlement plan. The company on Friday announced a “short extension” of its process to certify...
View ArticleResearchers downplay study that found a link between semaglutide and mental...
A growing body of research has done little to clear up concerns about whether there’s a link between GLP-1 drugs and depression, suicidal ideation and self harm. The latest research, an observational...
View ArticleTome Biosciences to lay off almost all workers
Tome Biosciences, a high-profile gene editing startup, will terminate nearly its entire workforce during the first two weeks of November. It disclosed plans to lay off 131 people in a Massachusetts...
View ArticleTome plans layoffs amid struggle; FDA turns away Regeneron; Next-gen obesity...
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...
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MBX Biosciences submits IPO plans around peptide pipeline
Indiana biotech startup MBX Biosciences filed for an initial public offering on Friday night. It became the third clinical-stage drug developer to do so in the span of two days, marking a mini-revival...
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Mubadala, CBC Group ink $680M deal for UCB’s neurology and allergy portfolio...
Belgian pharma UCB is selling parts of its China business to Mubadala and CBC Group for $680 million. In addition to taking over UCB’s “mature product portfolio” in China, the Abu Dhabi sovereign...
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Major Galapagos investor says it will push board on company's 'performance'...
One of Galapagos’ biggest shareholders is taking a more active role in pushing the company’s turnaround. Biotech investment firm EcoR1 Capital, which owns 9.9% of the company’s shares, said in a Friday...
View ArticleMpox vaccine collab; $11M oncology seed; Gates backs RSV vaccine; Kyowa Kirin...
Houston biotech closes $11.4 million seed round: Diakonos Oncology said the money will fund operations into late 2025. A Phase 2 trial testing its dendritic cell vaccine program in glioblastoma is...
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Once one of immuno-oncology's next great hopes, CD47 faces final shots on goal
Earlier this summer, a small biotech company’s readout in what was once one of cancer’s most intriguing approaches did little to settle the controversy and questions surrounding it. The CD47 pathway,...
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