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Citing the need for more time to review additional Chemistry, Manufacturing and Controls information, the FDA has extended its target action date for Rocket Pharmaceuticals’ investigational gene therapy by three months.

Roivant Sciences will wind down operations for Hemavant, which was formed two years ago to advance RVT-2001 as a potential first-in-class treatment for transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes.

Approved in combination with three chemotherapies, Onivyde is the first new frontline treatment option in more than 10 years for adults living with metastatic pancreatic adenocarcinoma.

With last year’s approval of Vertex and CRISPR’s Casgevy, it’s the start of a new era of gene editing. But there are still challenges we must face.

Two weeks after Vertex’s Phase III data for VX-548 reenergized the field, Latigo Biotherapeutics announced $135 million in Series A funds to push its own NaV1.8 inhibitor into Phase II.

In a tough funding environment, some biotechs are choosing to leave executive positions vacant and either spread responsibilities or find a part-time leader.

The neuroscience space saw a late push in merger and acquisition activity, while oncology start-ups reeled in the most venture capital funds. Industry leaders expect these trends to continue.

Studies presented Monday at the American Academy of Orthopaedic Surgeons annual meeting show semaglutide has positive impact on outcomes for total hip arthroplasty patients.

Plus, tips for finding biophama job opportunities, and when and how to follow up after a job interview.

The startup will use the money to fund a Phase II trial in combination with Eli Lilly’s Zepbound in the hopes of increased weight loss results, while attempting to protect body composition from muscle wasting.

In the fourth quarter of 2023, Biogen’s revenue from multiple sclerosis drugs fell 8% due to generics competition and the company paid $60 million in close out costs related to Alzheimer’s treatment Aduhelm.

Analysts say Novo Holdings made the right decision last week in scooping up the CDMO to increase manufacturing capacity for Novo Nordisk’s diabetes and weight-loss drugs.

• 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