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Illumina Ventures sets out for $300M third fund
A venture firm with Illumina as its majority investor is charging ahead with its next batch of capital as the DNA sequencing company endeavors on its own three-year return-to-growth strategy. Illumina...
View ArticleLiquidia 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...
View ArticleRegeneron wins EU approval for lymphoma bispecific following FDA rejection
EU regulatory authorities granted conditional approval to Regeneron’s bispecific antibody odronextamab for two forms of lymphoma. It’s Regeneron’s first bispecific antibody approval in the world after...
View ArticleAnother major PBM will cut AbbVie's Humira from its largest commercial...
Cigna’s pharmacy benefit manager Express Scripts said it will remove Humira from its largest commercial drug formularies in 2025 to make way for its biosimilars. The move will make Express Scripts the...
View ArticleNovartis to sell molecular imaging business to Siemens Healthineers
Novartis is selling off its molecular imaging business for positron emission tomography (PET) scans to Siemens Healthineers for an undisclosed amount, both companies confirmed to Endpoints News on...
View ArticleFederal agency opposes J&J's new 340B discount model, promises to take...
The federal government is challenging Johnson & Johnson’s plan to change how some hospitals receive drug price discounts under the 340B program. Last week, J&J announced that beginning Oct. 15,...
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