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A biopharma communications professional offers advice he wishes he’d received as a PhD student considering a career in industry.

Vorasidenib decreased tumor volume by a mean of 2.5% every six months, compared to growth of 13.9% for placebo over the same time span. The candidate is also being tested in a regimen with Keytruda.

As companies clamor for a piece of the antibody-drug conjugate pie, experts pose the question: is it possible to replicate the success of Enhertu?

Bayer’s investigational factor XIa inhibitor asundexian was inferior to BMS’ and Pfizer’s blockbuster blood thinner Eliquis (apixaban) in the Phase III OCEANIC-AF study.

Armed with a pipeline of obesity and diabetes hopefuls, Carmot Therapeutics joins the small group of biotechs to attempt a Nasdaq debut this year.

The U.K.’s conditional marketing authorization for Vertex Pharmaceuticals and CRISPR Therapeutics’ gene-edited therapy exa-cel raises some potential safety concerns with the risk of off-target effects.

In this deep dive, BioSpace examines how small, medium and large companies are using artificial intelligence and machine learning to enhance their drug discovery efforts.

The company’s Truqap, in combination with its endocrine therapy Faslodex, has been approved by the regulator for adult patients with advanced HR-positive breast cancer with specific biomarker alterations.

Xtandi is now approved to treat nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis with or without a gonadotropin-releasing hormone analog therapy.

In a 12-1 tally, the FDA’s Pulmonary-Allergy Drugs Advisory Committee determined that the data does not establish a clinically meaningful benefit in this indication.

The company won the third FDA approval in a month for the anti-PD-1 blockbuster, allowing its first-line use in locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

To help cope with the high demand for weight-loss treatments, Eli Lilly is investing $2.5 billion in a German manufacturing facility after last week’s FDA approval of Zepbound for chronic weight management.

• 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