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The regulator found no issues with mirikizumab’s clinical or safety data.

The new partnership involves an initial payout of $75 million and the potential for up to $2.6 billion in milestone funding.

New therapeutics for Major Depressive Disorder could change the treatment landscape and give patients more options.

The company has several targeted therapeutics in early-stage trials and preclinical development for cancer types with high expression levels of the protein.

The lawsuit, brought by Arbutus Biopharma, marks the latest legal action in an ongoing battle for intellectual property underlying mRNA vaccines for COVID-19.

Liver toxicities triggered a partial clinical hold on Merck KGaA’s trial studying its BTK inhibitor candidate for multiple sclerosis.

A look at the differences among types of retirement accounts, and how to evaluate which is best for you

Junshi Biosciences announced Tuesday that its ovarian cancer candidate, senaparib, met the primary endpoint in a Phase III interim analysis.

Following mixed Phase I/II data for its homocystinuria hopeful pegtarviliase, Aeglea lays off all but 10 employees and launches a sweeping strategic review.

An interim analysis of the Phase III P302 study showed Moderna’s investigational flu shot, mRNA-1010, fell short of the statistical threshold for early success.

A California judge denied Elizabeth Holmes’ motion for release pending appeal, ruling that the former Theranos CEO must serve her prison sentence while she appeals her guilty verdict.

BioSpace spoke with two professionals who have made the switch from tech roles to biotech to find out the benefits, challenges and tips for a smooth transition.

• 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