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The Massachusetts-based startup’s goal is to develop RNA medicines that can treat diseases anywhere in the body using an “all-in-one” platform.

The Swiss pharma has canceled a second mid-stage trial for its investigational schizophrenia drug ralmitaront, as the competition shows promise in the space.

Check out BioSpace’s guide to pharma tech jobs, complete with job descriptions and average salaries.

With the FDA’s approval on Monday, Ayvakit is the first and only treatment for adults with indolent systemic mastocytosis, a rare hematologic disorder, according to Blueprint Medicines.

Indivior’s Opvee is an emergency nasal spray medication to reverse opioid overdose approved for patients aged 12 years and above with signs of respiratory or central nervous system depression.

Ex-FDA Neuroscience Director Billy Dunn was appointed to Prothena’s board of directors last week. Industry representatives and regulatory experts weigh in on the potential ethical implications.

Data from a Phase III trial of apraglutide for a type of short bowel syndrome with intestinal failure is expected by the end of the year. It is also in a Phase II study for acute graft-versus-host disease.

The 61-patient study met the primary endpoint of improved physiologic liver function and secondary endpoints, which included established non-alcoholic steatohepatitis biomarkers, Hepion reported Monday.

Sanofi and Regeneron reported positive results for the anti-inflammatory drug in a chronic obstructive pulmonary disease trial. The companies hope to see approval before a 2024 read-out of a second trial.

The topical treatment Vyjuvek got the FDA’s greenlight, making it the first redosable gene therapy and the first therapeutic for the rare skin disease dystrophic epidermolysis bullosa.

With Friday’s approval, Epkinly edges out Roche’s bi-specific antibody glofitamab, which is also being proposed for diffuse large B-cell lymphoma.

Crohn’s disease is Rinvoq’s seventh approved indication and could potentially help AbbVie weather declining sales for its blockbuster biologic Humira.

• 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