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

FDA approves Lilly's once-weekly basal insulin Onswik for type 2 diabetes, Lilly forms a five-target discovery pact with InnoCare worth up to $3.35 billion, and Roche's sefaxersen hits in a phase 3 IgA nephropathy trial.
pharminent September 24, 2026

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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Pharminent — Competitive Intelligence Suite · Tickers link to Yahoo Finance for reference only. Editorial framings are analysis, not investment advice. © 2026.

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