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Thursday, Astellas announced that the FDA had lifted its clinical hold for the company’s experimental gene therapy trial for late-onset Pompe disease.

The FDA issued a complete response letter Thursday refusing accelerated approval for Eli Lilly’s Alzheimer’s disease candidate donanemab.

Disc Medicine inked an exclusive license agreement with Mabwell Therapeutics for the latter’s portfolio of monoclonal antibodies against the TMPRSS6 protein.

bluebird bio, Inc. is expecting gross proceeds of $120 million with its newly announced public offering of 20,000,000 shares.

Jazz Pharmaceuticals and Zymeworks announced results from a Phase II trial of the latter’s HER2-targeted antibody for metastatic gastroesophageal adenocarcinoma.

Roche’s Tecentriq (atezolizumab) combined with Avastin (bevacizumab) met the primary efficacy endpoint in early-stage hepatocellular carcinoma in the Phase III IMbrave050 study.

Editas announced the sale of its iPSC-derived iNK programs to Shoreline Biosciences. Shoreline also licensed Editas’ SLEEK technology.

Johnson & Johnson discontinued the Phase III trial of an investigational HIV vaccine regimen Wednesday after an independent review showed it was ineffective at preventing disease.

The neurodegenerative drug development space saw incremental victories in 2022. Leaders from Eisai, Voyager and QurAlis discuss upcoming milestones.

Breast cancer came in as the most studied disease in 2022, according to the patient data analytics firm Phesi.

The FTC issued a Notice of Proposed Rulemaking (NPRM) that could change the landscape for employer-employee relationships nationwide, specifically in the biopharma industry.

Horizon Therapeutics’ dazodalibep met the primary endpoint in a second straight Phase II trial for Sjögren’s syndrome.

• 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