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A second patient death has been linked to the Phase III clinical trial of Eisai and Biogen’s investigational Alzheimer’s drug lecanemab, according to the journal Science.

BioMark Diagnostics Inc. (CSE: BUX) (FSE: 20B) (OTC Pink: BMKDF) (“BioMark” or the “Company”) (an advanced stage liquid biopsy company with a focus on hard to detect and treat cancers is pleased to reports that it will amend the term of the non-broker warrants (the “Warrants”) issued in relation to a private placement financing that closed on December 13, 2019 on a continuing effort to improve corporate value for its shareholders.

Spectrum Pharmaceuticals made the call Friday to slash three-fourths of its workforce on the heels of a Complete Response Letter from the FDA.

Shares of CinCor Pharma fell more than 50% in premarket trading Monday after its investigational blood pressure drug failed to meet the primary endpoint in a Phase II trial.

Many executives haven’t established their personal brands or even know that they need one. BioSpace spoke with top executives in the field to learn about the importance of a personal executive brand.

The FDA has accepted Sarepta’s BLA for the accelerated approval of SRP-9001, an investigational gene therapy for DMD. Roche is responsible for commercialization outside the U.S.

C4X entered into a licensing deal with AstraZeneca to develop an oral treatment for COPD and other inflammatory and respiratory illnesses that could reach $402 million.

A Phase III trial of Axsome Therapeutics’ AXS-05 hit both the primary and secondary endpoints in patients with Alzheimer’s disease agitation, the New York-based company announced Monday.

Many biopharma companies raised funds in 2022, but not enough to reach their next milestone. Investors have been constricting investments, so companies needing additional funding require a larger toolbox.

BioSpace spoke with Dr. Kiana Aran to discuss her life, her accomplishments and what it means to be a successful woman in science on a global scale.

BioMarin Pharmaceutical announced the FDA no longer plans to hold an advisory committee meeting to review its BLA for Roctavian an AAV gene therapy for adults with severe hemophilia A.

Novartis and Medicines for Malaria Venture are moving into Phase III for a combination treatment targeting the rise of artemisinin-resistant Malaria infection.

• 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