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Late Monday, Arvinas Inc. was forced to divulge the contents of its upcoming breast cancer data presentation, slated for the 2022 San Antonio Breast Cancer Symposium (“SABCS”).

The FDA granted priority review to Takeda’s Biologics License Application for TAK-003, a dengue vaccine candidate. The vaccine to date is only approved for use in Indonesia.

The FDA approved CSL Behring and uniQure’s Hemgenix, a one-time gene therapy developed for adults with Hemophilia B,the companies announced Tuesday afternoon.

Merck is eyeing another major label expansion for its flagship anti-PD-1 therapy Keytruda following an interim analysis of KEYNOTE-859 trial.

The FDA granted argenx Priority Review status for the company’s BLA for SC efgartigimod for generalized myasthenia gravis.

Following a request from the FDA, GSK is withdrawing its multiple myeloma drug Blenrep from the U.S. market while continuing to push other combination trial programs.

In a volatile year, marked with challenges, BioSpace is taking a pause to reflect on the many “wins” in biopharma.

Lysogene’s investigational gene therapy LYS-SAF302 failed to meet its primary and key secondary efficacy endpoints in mucopolysaccharidosis type IIIA.

With a $1.36 billion buyout, Merck bolstered its oncology program with the acquisition of Biotech Bay-based Imago Biosciences, a company focused on chronic bone marrow cancers.

Teva Pharmaceuticals has found its new president and CEO. Effective Jan. 1, 2023, Richard Francis will take the company’s reins as Kåre Schultz retires.

The FDA has a number of PDUFA dates for the remainder of November for Spectrum, ImmunoGen, Scynexis and Y-mAbs.

Former Theranos CEO Elizabeth Holmes will serve 11 years in prison on four counts of fraud, according to her sentencing by a federal judge in a California courtroom on Friday afternoon.

• 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