Pharminent · Daily Brief

September 24, 2026
Regulatory & Approvals

FDA approves Lilly’s once-weekly basal insulin Onswik for type 2 diabetes

The FDA approved Lilly’s Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection for adults living with type 2 diabetes. Lilly said Onswik is designed to reduce injections by more than 300 per year versus once-daily basal insulin.

Eli Lilly →$LLY

FDA advisers vote in favor of Grail’s Galleri multi-cancer blood test

FDA expert advisers voted in favor of Grail’s Galleri blood test for detecting multiple cancers, with some panelists expressing misgivings about the test’s efficacy.

Pharmaphorum →

FDA commissioner nominee Heidi Overton to face Senate confirmation hearing

Heidi Overton, President Trump’s pick to lead the FDA, will take questions at a Senate confirmation hearing.

STAT →

Federal court enters consent decree against Gold Star Distribution

An FDA investigation resulted in a federal court order dated September 21, 2026, stopping warehouse operator Gold Star Distribution from distributing FDA-regulated products, including food, drugs, medical devices and cosmetics, until it brings its operations into compliance with federal legal requirements.

FDA →
Clinical Data

Roche’s sefaxersen meets endpoint in phase 3 IgA nephropathy trial

Roche reported that sefaxersen, an antisense oligonucleotide licensed from Ionis Pharmaceuticals, achieved statistically significant and clinically meaningful results in a phase 3 trial in immunoglobulin A nephropathy (IgAN).

MedCity News →$RHHBY$IONS

Kyverna reports one-year data for autoimmune CAR-T miv-cel

Kyverna Therapeutics reported long-term clinical data for miv-cel showing sustained efficacy at one year alongside an unblemished safety profile for the potential first-in-class candidate.

Fierce Biotech →
Deals & Partnerships

Lilly commits $100M upfront in five-target InnoCare discovery pact

Eli Lilly has committed $100 million in upfront and near-term payments to China’s InnoCare Pharma to form a five-target drug discovery partnership. The agreement includes up to $3.25 billion in milestone payments.

Fierce Biotech →$LLY
Business & Finance

Enveda raises $311M in venture funding for AI drug discovery

Enveda, which uses AI tools to mine plants and microbes for drug prospects, raised $311 million in venture funding. The company has three candidates in human testing for immune diseases and obesity.

BioPharma Dive →

Basecamp Research secures $140M Series C for AI-designed therapies

Basecamp Research raised $140 million in a Series C round to train a new generation of its EDEN biological foundation models and advance AI-designed therapies toward clinical development.

Pharmaceutical Technology →

Nine pharma leaders call for action on European biotech decline

Nine pharmaceutical industry leaders signed a letter warning about a slump that has seen Europe lose ground to the U.S. and China, calling for speedier clinical trials, intellectual property protections and “fiscal flexibility.”

BioPharma Dive →

Teal Health raises $22M for at-home HPV cervical cancer screening device

Teal Health secured $22 million in a Series A round for its at-home HPV cervical cancer screening device. The round was led by .406 Ventures, with participation from Emerson Collective (managed by Yosemite), Forerunner, Serena Ventures and Japan-based MPower Partners.

MedCity News →

Lilly stops publicly listing its phase 1 pipeline programs

Lilly no longer publicly lists its earliest clinical programs, removing phase 1 candidates from its disclosed pipeline.

PharmaVoice →$LLY

Novo’s CEO says company can broaden ambitions again

Novo CEO Mike Doustdar told CNBC the company has reached the point where it can broaden its ambitions again under its new strategy, though investors remain unconvinced.

CNBC →$NVO

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