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A legislative proposal, if passed into law, could cost the United States up to 1.2 million jobs and lead to more than 130 fewer FDA approvals over a 10-year period, according to a new report.

CBER Director Peter Marks recently spoke in favor of single-arm trials in certain situations, but clinicians and ethicists say there are several variables to consider.

The bladder cancer-focused biotech is looking to be one of the first companies out of the gate with an initial public offering in 2024.

Regulatory authorities worldwide are tightening their monitoring mechanisms and launching their own investigations after reports of secondary malignancies potentially linked to chimeric antigen receptor T cell therapies.

Taiwanese contract development and manufacturing organization Bora will purchase Minnesota-based Upsher-Smith Laboratories, expanding operations into the U.S. for the first time.

The FDA’s Complete Response Letter identified problems with the drug candidate’s chemistry, manufacturing and controls, parent company Shin Nippon Biomedical Laboratories announced Thursday.

The Swiss pharma’s Phase III trial of ligelizumab in patients with peanut allergies has been terminated, according to a ClinicalTrials.gov update on Tuesday.

The San Diego-based startup, specializing in allogeneic engineered Treg and CAR-Treg cell therapies, plans to be in Phase I clinical trials in multiple indications in 2024.

Despite offering discounts that reach as high as 85%, Humira biosimilars are finding it difficult to take market share away from the AbbVie blockbuster, according to a new report from Samsung Bioepis.

The sweeping changes are meant to “reduce hierarchies” and “accelerate decision-making” as Bayer weathers several business crises and continues to suffer from the fallout of its disastrous Monsanto acquisition.

In a changing landscape, top companies are increasingly embracing remote work.

People who worked in the industry around the time that BioSpace launched its Hotbeds Maps—including Marc Goldberg, a MassBio co-founder, and Biocom leader Joe Panetta—spoke with us about their experiences.

• 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