Latest News
& Press Releases

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
Pieris Pharmaceuticals announced partner AstraZeneca’s decision to discontinue clinical studies of elarekibep, an inhaled IL-4 receptor alpha inhibitor, based on a non-clinical toxicology study.
The majority of ALS patients are excluded from clinical trials. Experts say using biomarkers and stratifying trial populations can expand eligibility and provide additional scientific insights.
For some, increased productivity means taking fewer breaks. But new research suggests the opposite may be true.
On the heels of Merck’s and BMS’ lawsuits, the pharma industry’s lobbying group Wednesday filed a complaint in federal court asserting that the price-setting provisions in the Inflation Reduction Act are unconstitutional.
The Huntington’s disease space saw a flurry of activity Wednesday as PTC and uniQure released data from their respective mid-phase trials.
FDA
Argenx’s Vyvgart will now be available in the U.S. as a more convenient subcutaneous formulation 18 months after its first approval.
The startup launches with $50 million to improve its Chemilogics platform, which is designed to speed up the identification and development of small molecule drug candidates.
Here are the top biotech companies in California hiring now on BioSpace’s life sciences–focused job board.
FDA
The FDA has approved Jardiance and Synjardy as the first SGLT-2 inhibitors to treat pediatric Type 2 diabetes, providing a new class of oral medicines.
Following an FDA warning in May, Novo Nordisk has filed several lawsuits against spas, clinics and pharmacies selling compounded version of semaglutide.
An International Chamber of Commerce arbitration tribunal has dismissed Boehringer’s attempt to seek indemnification from Sanofi for the ongoing Zantac lawsuits faced by the companies.
Biopharma executives suggested that some companies might seek to bypass the U.S. government’s national health insurance program altogether, among other sweeping changes to drug development.
UPCOMING EVENTS
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
MARKET RESEARCH REPORTS