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Kissei Pharmaceutical is reversing a recommendation related to Amgen-shared Tavneos that it made just a few days ago, now saying the rare disease drug can be given to new patients.

By partnering with a UN-backed body, Roche has enabled companies to make the medicine for supply in 129 countries.

Lilly met analysts’ sky-high expectations with 28.3% weight loss over 80 weeks for the triple hormone receptor agonist retatrutide in a highly anticipated readout on Thursday.

In September last year, a group of concerned stockholders raised alarm about Vaxart’s proposed reverse stock split, which the biotech was pushing for despite strong opposition from shareholders.

A trifecta of newly inked tech partnerships—from Eli Lilly, Bristol Myers Squibb and Incyte—exemplify the increasingly central role that AI is playing in drug development.

After being hit by safety issues and subpar results in another trial, BioMarin’s Phase 3 test of Voxzogo for a rare skeletal disorder called hypochondroplasia showed efficacy “solidly above” what the drug has shown for achondroplasia, which causes dwarfism.

In this episode of Denatured, as part of our series on the European life sciences investment ecosystem, you’ll be hearing from Regina Hodits, managing director at Angelini Ventures and Sofia Ioannidou, VC partner at Andera Life Sciences. They explore Germany’s biotech and life sciences ecosystem, including the science, infrastructure and policy changes needed to help European companies scale globally while staying rooted in Europe.

The number of biotech and pharma professionals taking jobs they’re overqualified for is now over 50%, based on a BioSpace LinkedIn poll. A recruiting firm executive discusses the trend, the reasons behind it and why it doesn’t have to derail careers.

Eli Lilly joins hands with Engage Bio, acquiring the DNA delivery platform developer in hopes of bolstering its genetic medicines portfolio.

While the manufacturer is on the list of authorized GLP-1 importers, FDA inspectors found the company relabeled APIs from another site in a potential attempt to “circumvent safeguards.”

FDA veteran Richard Pazdur outlined his priorities for the next FDA commissioner but stopped short of putting himself forward as a candidate to lead the agency at an RBC Capital Markets event on Tuesday.

While the pathogen appears unlikely to trigger a pandemic, analysts see potential for Moderna to build goodwill amid a period of political pressure on vaccine manufacturers.

• 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