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FDA inspectors found evidence that the compounding pharmacy was making versions of Eli Lilly’s tirzepatide and Novo’s semaglutide “regularly or in inordinate amounts” at a site with “insanitary conditions.”

In Thursday’s Senate committee meeting, FDA commissioner nominee Heidi Overton was repeatedly questioned about her ability to retain the FDA’s independence under President Donald Trump, as well as her views on vaccines and abortion drugs.

While Acadia Pharmaceuticals’ candidate has missed the main goal of a Phase 2 trial, the company is still moving forward with the anti-psychosis candidate in Alzheimer’s disease as well as Lewy body dementia.

Analysts were keen to see a new modality compete with Roche’s approved drug Lucentis in the late-stage trial but new safety issues could complicate the future for Merck’s candidate.

Kyverna Therapeutics’ miv-cel showed improved mobility and a favorable safety profile at one year in patients with stiff person syndrome, further derisking an upcoming FDA application, William Blair said on Thursday. The biotech plans to file for priority review this year.

The weekly insulin Onswik will now be available to U.S. patients after initial approvals in Europe, Mexico and Japan.

Basecamp Research joins the growing group of AI-forward biotechs that in recent months have brought in notable sums from investors, including Isomorphic Labs and Enveda.

The new partnership follows Roche’s recent R&D expansion in Boston focused on development for cardiovascular, renal and metabolic diseases.

InnoCare Pharma is the latest addition to Eli Lilly’s dealmaking spree, which includes some of the biggest acquisitions this year: up to $7 billion for Kelonia Therapeutics in April and up to $7.8 billion for Centessa Pharmaceuticals in March.

In this episode of Denatured presented by Curium, Jennifer Smith-Parker speaks to Mike Patterson, CEO North America and Professor Sabine Brookman-May, vice president and head of Global Clinical Development. We look at the momentum behind radioligand therapy and how its diagnostic and therapeutic capabilities are improving care for more than 14 million patients worldwide.

WeGuide Pty Ltd will receive A$1.9 million to build a world first platform in developing commercial multi-modal biomarkers. Building their first use case with NeuRA on mobility recovery, the platform accelerates regulatory-approved biomarker development for researchers, health organisations and pharmaceutical companies working to bring precision medicine tools to patients and trial participants.

Amendment extends TEM relationship beyond Panama into additional Latin American markets, adds VIVI Med(TM) to the distribution framework, and supports broader regional availability following product registrations Highlights TempraMed and TEM Consulting International S.A. execute amendment expanding the distribution relationship beyond Panama to additional Latin American markets. • The amended framework adds VIVI Med™ to the covered product portfolio, alongside VIVI Cap™ and VIVI Epi™. • TempraMed received an additional commercial order from TEM, expected to be fulfilled by the end of September 2026. • Initial extended-territory framework contemplates minimum units across the added countries, with additional annual commitments tied to exclusivity. • Once required registrations are completed, TempraMed products are expected to be available through distribution relationships covering seven Latin American countries representing a substantial majority of the region’s population. • TempraMed expects to raise up toC$1,000,000 through non-brokered private placement of Units

— First-in-Human Study: Completion of dosing was achieved in PMG1016-1031 Phase 1a Study in Healthy Volunteers —

Company outlines broader scientific-development priorities focused on microbiome research, formulation evaluation, and long-term growth.