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Browse the latest news from BioSpace, and press releases from around the industry. Want to filter by date, keyword, and more? Search here.
TOP STORIES
With some proactive measures, you can make it more likely your stocks will remain yours in the event of a layoff.
Peter Marks described the steps the agency is taking to advance the development of gene therapies for rare disorders. This could spell good news in the near future for Sarepta Therapeutics.
BioNTech inked an exclusive worldwide license and collaboration agreement with OncoC4 to develop and commercialize its investigational anti-CTLA-4 antibody ONC-392 for solid tumors.
Takeda will advance its experimental drug for plaque psoriasis, TAK-279, to Phase III later this year after the TYK2 inhibitor met its primary and secondary endpoints in a Phase IIb study.
Karuna Therapeutics released data Monday from the Phase III EMERGENT-3 trial showing that KarXT met the primary endpoint, significantly improving symptom severity.
As demand for biotech talent increases, the need to offer competitive pay to the average employee puts financial pressure on companies to increase CEO pay as well.
Biomarkers as a surrogate endpoint in ALS will go on trial on March 22 as Biogen and Ionis’s tofersen faces the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee.
Sangamo Therapeutics lost two powerhouse partners Friday after it reported that both Novartis and Biogen discontinued focusing on gene regulation therapies in the neurology space.
On Feb. 28, Novavax issued a candid warning to investors: it may not be able to continue operations beyond February 2024. BioSpace takes a deep dive into the vaccine maker’s prospects.
For Daiichi Sankyo, recent results from the Phase III CLEAR trial of Esperion Therapeutics’ Nexletol (bempedoic acid) were not convincing enough to trigger a milestone payment.
An advisory committee will meet March 22 to discuss the fate of Biogen and Ionis’ ALS hopeful tofersen. For that and more, see inside.
Pfizer and Astellas announced positive topline Phase III results Thursday for Xtandi plus leuprolide in non-metastatic castration-sensitive prostate cancer.
PRESS RELEASES
• Appointment strengthens medical, regulatory, and commercial leadership as Company prepares to complete early market access regulatory filings in the U.S., U.K, Europe and Australia in anticipation of OST-HER2 approval decisions expected by year-end 2026 • Upcoming FDA Pre-BLA meeting will focus on the use of recent seroconversion biomarker data as a key surrogate clinical efficacy endpoint to support a BLA for OST-HER2 under the Accelerated Approval Program • Commercialization and reimbursement preparations well underway for the U.S., U.K., and Europe in parallel with ongoing partnership discussions
• Quarterly revenue up 8% year over year; Annual revenue guidance range remains at $42-$48 million • CDMO fragrance and Saffron projects reach successful milestones; First quarter CDMO revenue grew 135% YoY • VINIA brand customer base grows to 90,000 active users as of the end of April • Two-lens framework enacted in Q1 to optimize performance across CDMO and D2C businesses
Business development appointment is aligned with securing long-term customers for development and manufacturing partnerships
Another major milestone in its continuous global IP strategy, advancing protection of VIVI Cap Smart across international markets Highlights Granted Patent covers the design of VIVI Cap Smart™ across major international, growing market Strengthens the Company’s intellectual property position in one of the world’s largest healthcare and consumer markets Supports commercialization strategy and strategic discussions with appliance manufacturers Design term extends through May 16, 2039 Company enters into financing arrangement to support inventory build for growing portfolio