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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
As life sciences companies feel the burn of the current economy, one Bay Area biotech, CODA Biotherapeutics, quietly shut its doors.
An independent panel of advisers voted to approve Genentech’s Polivy after internal FDA staff raised concerns regarding the efficacy and risk-benefit profile as a first-line treatment for large B-cell lymphoma.
Three years after the FDA rejected its initial biologic license application, Mesoblast announced its resubmission for Ryoncil. Now, the treatment is getting a second chance.
Women are often at the forefront of innovation, making up nearly half of the life sciences industry despite a shrinking but persistent wage gap. Inceptor Bio is at the forefront of closing inequality.
If biopharma-focused co-working spaces continue to catch on, they could expand job opportunities for those outside of the typical hot spots.
BioMarin announced Tuesday that the FDA has accepted its supplemental New Drug Application to expand Voxzogo for children younger than five years with achondroplasia.
The past two decades were all about nucleic acid reading and writing. The next is about delivering DNA and RNA, Yogev Debbi, CEO of Mana.bio, told BioSpace in an interview.
Volastra Therapeutics has in-licensed Amgen’s sovilnesib, a KIF18A inhibitor being studied for high-grade ovarian cancer, triple-negative breast cancer and other solid tumors.
BridgeBio posted data Monday from its small but highly anticipated Phase II study of infigratinib in achondroplasia - a drug that could give BioMarin a run for its money.
Rapport Therapeutics, a clinical-stage biotech aiming to develop precision medicines for neurological disorders, launched Tuesday with $100 million in Series A financing.
Merck presented Phase IIb data at ACC Monday showing that its hypercholesterolemia hopeful met the primary endpoint.
Moderna may seek the FDA’s accelerated approval for its personalized cancer vaccine, president Stephen Hoge said Monday.
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