Latest News
& Press Releases

Data show the potential of Editas’ sickle cell disease and transfusion-dependent beta thalassemia gene therapy candidate, but it might not be enough to overtake Vertex and CRISPR Therapeutics.

The FDA has launched a new super office to prepare for myriad decisions on cell and gene therapies, including the potential first CRISPR therapy and the first gene therapy for Duchenne muscular dystrophy.

The FDA’s Antimicrobial Drugs Advisory Committee voted 21–0 that the companies’ respiratory syncytial virus antibody, nirsevimab, has a favorable benefit-risk profile in infants and young children.

The FDA has four target action dates this week for three supplemental approvals and one New Drug Approval.

The company said Thursday it has closed $200 million in Series B financing—on top of last year’s $200 million Series A haul—to help initiate a registrational Phase II study for its lead candidate UPB-101.

With the 2023 American Society of Clinical Oncology meeting in the history books, BioSpace takes a look back at the presented data that oncologists think will be most practice-changing.

A total of nine U.S. cities stood out in terms of total NIH funding in 2022.

The start-up’s lead program, BRB-002, is designed to target the CD47/SIRPα pathway and the underlying causes of vascular inflammation and atherosclerosis.

Astellas Pharma will license and further develop a gene therapy from Kate Therapeutics aimed at addressing XLMTM amid safety concerns about its own experimental XLMTM treatment.

A class-action lawsuit from thousands of third-party payers alleges that the companies broke racketeering laws to market their diabetes drug Actos, while not disclosing its bladder cancer risk.

In a 6-0 vote, the FDA’s advisory committee Friday affirmed that trial data confirmed the clinical benefit of Eisai and Biogen’s Leqembi (lecanemab) for the treatment of Alzheimer’s disease.

Polaris Group (TWSE: 6550), a multinational biopharmaceutical company focused on research and development of novel biological drugs for cancer and other metabolic diseases, today announced...

• 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