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With Eisai and Biogen’s Leqembi now fully approved, researchers are exploring combinations—including with therapies targeting tau and microglial function—that could increase its effectiveness.

BioSpace rounded up companies with products for Alzheimer’s, ALS, Parkinson’s and Huntington’s in the final stages of clinical testing.

Johnson & Johnson and Astellas are the latest companies to file suits against the Biden administration, challenging the constitutionality of the Inflation Reduction Act’s Drug Price Negotiation Program.

Late-stage study suggests Merck’s Keytruda is a promising treatment candidate in newly diagnosed patients with locally advanced cervical cancer, inducing better progression-free survival.

With its primary patent expiring in India this week, MSF has urged Johnson & Johnson to drop all secondary protections and withdraw pending applications for the drug-resistant tuberculosis drug.

J&J, Merck and Pfizer are the subjects of a House Judiciary Committee investigation for their alleged participation in a government-sanctioned censorship campaign during the COVID-19 pandemic.

Industry advocates argue price negotiation via the IRA may jeopardize the prices relied upon by biosimilar manufacturers to recoup their investments.

Next-gen biomanufacturers are particularly susceptible to the challenges inherent in manufacturing cell and gene therapies, risking getting derailed by unexpected costs for already-tight budgets.

The company also terminated a Phase III trial of its TGFB inhibitor as a treatment for metastatic pancreatic ductal adenocarcinoma, though that drug will continue to be tested as a treatment for colorectal cancer.

Tuesday’s partnership will dig into Flagship’s deep ecosystem of companies and technologies to discover medicines in line with Pfizer’s core strategic areas.

Less than two years after launch, the startup posts positive Phase II results and heads into Phase III trials for major depressive disorder with a new CEO.

Following the full approval of Leqembi, the CMS suggests expanding its coverage of beta-amyloid PET scans, which could improve the uptake of novel Alzheimer’s disease treatments.

• 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