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This week’s meeting of the Advisory Committee on Immunization Practices will be led by Kirk Milhoan, a physician and pastor who recently claimed that COVID-19 vaccines contained a contamination that causes cancer.

Agentic AI can help FDA staff manage meetings, conduct pre-market reviews and validate reports, among other tasks, though the agency emphasized that using this technology is optional for its employees.

Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected.

U.K.-based pharmas will not face tariffs as long as Donald Trump is president, according to the agreement.

Following Novo Nordisk’s price cuts for its own GLP-1 medicines, Eli Lilly is offering discounts for the obesity drug purchased through LillyDirect. Both pharmas recently struck a deal with the White House for cheaper prices via the yet-to-be-launched TrumpRx.

Protego Biopharma is advancing a small-molecule drug that helps light chain proteins fold correctly, in turn addressing the underlying biological cause of AL amyloidosis.

The centerpiece of the deal is the in vivo editor TSRA-196, which in preclinical studies has shown robust editing at SERPINA1, the locus linked to alpha-1 antitrypsin deficiency.

The alleged deaths were detected by the FDA’s Vaccine Adverse Event Reporting System, reports from which “generally cannot be used to determine” causation or even contribution, according to the agency.

If approved, Ascendis’ TransCon CNP would become the second therapy for achondroplasia, challenging BioMarin’s Voxzogo.

As bispecifics, ADCs, protein degraders, and AI-designed mini-proteins move into the clinic, discovery teams face a new bottleneck: engineering and producing molecules whose complexity challenges conventional workflows.

As big pharmas including Takeda and Novo Nordisk flee the cell therapy space and smaller biotechs shutter their operations, these players are sticking around to take the modality as far as it can go.

The FDA’s docket in December includes decisions for two big biologic franchises: BMS’s Breyanzi and Amgen’s Uplizna.

• 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