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The biotech Monday announced a clinical hold on its HEMO-CAR-T candidate, which is being trialed for the treatment of acute myeloid leukemia, due to manufacturing concerns cited by the regulator.

After its Biologics License Application was rejected by the FDA, BrainStorm’s Phase III data suggest its amyotrophic lateral sclerosis candidate significantly lowers neurofilament light chain levels.

Johnson & Johnson has licensed Nanobiotix’s lead radioenhancer candidate, designed to increase the efficacy of radiation treatment in cancers, capitalizing on the latter’s rocky financial situation.

The biotech will supply Canada with fewer doses of its coronavirus vaccine while reaching a financial agreement for the forfeiting of certain doses previously scheduled for delivery.

After an initial series of legal complaints in June, Novo Nordisk filed four new lawsuits Thursday against Florida and Tennessee pharmacies for allegedly selling products containing semaglutide.

Gene editing technologies are advancing rapidly in the clinic, with the potential first approval later this year, but challenges remain.

Phase III trial data published Thursday show significant survival benefit as a first-line treatment in advanced non-small cell lung cancer patients not fit for standard platinum-based doublet chemotherapy.

Following the FDA’s full approval of the Alzheimer’s drug Thursday, the Centers for Medicare and Medicaid Services confirmed broader coverage of Leqembi and released more details on a registry.

Thursday, Eisai and Biogen’s Leqembi also became the first disease-modifying treatment for Alzheimer’s to win traditional approval. CMS coverage is expected to begin immediately.

The proportion of supplemental indications rated as having high therapeutic value was substantially lower than for first indications, according to a new study published Wednesday in The BMJ.

The European Medicines Agency recently flagged a safety signal related to GLP-1 receptor agonists and sent a list of questions to manufacturers including Novo Nordisk, Eli Lilly, Sanofi and AstraZeneca.

The layoffs are a result of Sumitomo’s decision announced in April to combine its seven subsidiaries into one company.

• 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