BioSpace

The European Union’s health regulatory agency did not endorse approving @Sarepta's Elevidys for ambulatory patients with Duchenne muscular dystrophy. #genetherapy #pharma #biospace hubs.li/Q03yVlqC0

Despite the failure of its Recognify-partnered inidascamine, Jefferies analysts do not expect a definitively negative stock impact on atai, given the company’s promising psychedelic pipeline. #schizophrenia #pharma #biospace hubs.li/Q03z34xc0

Acknowledging the limits of disease-modifying drugs like Leqembi and Kisunla, companies like Bristol Myers Squibb, Acadia, Otsuka and Lundbeck are renewing a decades-old search for symptomatic treatments, including in high-profile drugs like Cobenfy. #alzheimers #biopharma…

These five upcoming data drops could usher in more effective and convenient therapies for Alzheimer’s disease and open up novel pathways of action to treat the memory-robbing illness. #alzheimers #biospace hubs.li/Q03z35_t0

The Commissioner’s National Priority Vouchers aim to offer accelerated pathways to drugs that meet certain criteria, perhaps including a low price-tag. But the policy is vaguely defined and was announced without public input, going against the FDA’s own published practices,…

The @EliLillyandCo and Gate Bioscience collaboration focuses on ‘molecular gates,’ a class of molecules that startup Gate says can stop pathogenic proteins from leaving the cell. #moleculargates #molecules #biospace hubs.li/Q03yVpsT0

As part of its pipeline prioritization initiative, announced on Tuesday, Adicet Bio is slimming down by 30%. Get the details in our layoff tracker. #layoffs #biopharma #biospace hubs.li/Q03yVhYL0

The strategic reprioritization comes after @RocketPharma hit two major hurdles in the past year, including a clinical hold for an investigational gene therapy and a @US_FDA rejection for its lead asset. #layoffs #fda #biotech #biospace hubs.li/Q03yTZ-t0

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an anonymous senior @US_FDA official. Given Elevidys’ full approval, however, experts told BioSpace this path would set up a length legal battle between the…

The company didn’t share specific data for the molecule, gefurulimab, but said it hit all endpoints in the Phase III PREVAIL trial and promised to share more at an upcoming scientific meeting. #pharma #autoimmune #biospace hubs.li/Q03yLy0s0

The partnership with Matchpoint Therapeutics gets Novartis global rights on all molecules for several unannounced inflammatory diseases identified through the biotech’s discovery platform. #biotech #biospace hubs.li/Q03yLr4J0

Companies sometimes miss the mark when it comes to telling employees they’re out of a job. From accidental goodbyes to surprise meetings, there are many strange ways biopharma professionals have learned about layoffs. #layoffs #biopharma #biospace hubs.li/Q03yLngK0

The Washington, D.C.–Baltimore area ranks in the top six for life sciences R&D and manufacturing talent, according to a CBRE report. The @MDBiz director of life sciences discusses the workforce and how the state is adapting to changing needs. #Maryland #biopharma #biospace…

Second-quarter earnings come amid many high-level challenges for the biopharma industry. How will these five closely watched biotechs fare? #biopharma #biospace hubs.ly/Q03yKs940

The new target action date for Blenrep, which GSK is proposing for the second-line treatment of relapsed or refractory multiple myeloma, is Oct. 23. #ADC #FDA #biospace hubs.ly/Q03yKr8C0

The latest round of terminations, which will take effect Sept. 15, comes after Genentech fired more than 500 employees in the last 15 months. #layoffs #biospace hubs.ly/Q03yKp0f0

Roche obtained CT-173, a PYY mimetic, in its $2.7 billion acquisition of Carmot Therapeutics in December 2023. The company reported the change in its second quarter earnings call. #Pharma #obesity #biospace hubs.ly/Q03yKjtJ0

While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience that would make change possible. #FDA #pharma #biospace hubs.li/Q03yzZLj0

The decision follows last month’s vote of the CDC’s revamped vaccine advisory committee. Thimerosal, mostly removed from vaccines decades ago, has long been a target of anti-vaccine advocates for unfounded links to autism and adverse health outcomes. #vaccines #CDC #biospace…

Looking for a biopharma job in California? Check out our list of 11 companies hiring life sciences professionals like you. #nowhiring #biopharma #biospace hubs.li/Q03ytSDT0