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However, a lack of regulatory harmonization risks undermining the effective implementation of these technology-driven approaches.

Citing lack of evidence and manufacturing issues, the regulator has rejected Outlook Therapeutics’ bid to have its bevacizumab formulation approved for wet age-related macular degeneration.

In the latest salvo, Pfizer and BioNTech fired back at Moderna and asked the U.S. Patent and Trademark Office to invalidate patent claims over the COVID-19 vaccines they say are overly broad.

The company’s pamrevlumab has failed another late-stage study in Duchenne muscular dystrophy, unable to significantly improve functional motor abilities over placebo.

Bristol Myers Squibb announced Monday that Reblozyl is now approved as a first-line treatment for adults with anemia due to myelodysplastic syndromes who may require regular blood transfusions.

The Biden administration on Tuesday released a much-anticipated list of the first 10 medicines included in Medicare’s Drug Price Negotiation Program under the Inflation Reduction Act.

Warning signs that preceded the current economic squeeze in the biopharma sector were not heeded by investors seeking rapid profits. Now, biotechs interested in making the leap to the public markets must get creative.

Lupin Pharmaceuticals’ recall of Tydemy birth control is the latest in a string of problems with India-based generic drug manufacturers.

Data from the first-in-human trial showed that Eli Lilly’s muvalaplin is safe and can cut significant levels of lipoprotein(a), a risk factor for atherosclerosis and related cardiovascular diseases.

The company’s investigational electric field therapy was unable to elicit significant survival benefits in patients with platinum-resistant ovarian cancer.

The British drugmaker filed a lawsuit on Friday in the U.S. District Court for the District of Delaware claiming the Inflation Reduction Act conflicts with the goals of the Orphan Drug Act.

The late-stage results for acoramidis, BridgeBio’s transthyretin amyloid cardiomyopathy candidate, indicate significant survival, functional and biomarker improvements over placebo.

• 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