October 6, 2025

The need-to-know this morning

Stoke Therapeutics appointed Ian Smith as its permanent CEO. He had been interim CEO since March.
Invivyd reached an agreement with the FDA to conduct two clinical trials of its antibody treatment for the prevention of Covid-19 infection to support a potential approval. The studies will start before the end of the year and will report top-line results in the middle of 2026.
AstraZeneca and Daiichi Sankyo said their antibody-drug conjugate Datroway prolonged survival in patients with advanced triple-negative breast cancer for whom immunotherapy was not an option.
Abivax presented additional results from a study of its experimental drug, called obefazimod, for ulcerative colitis.

Pharma

Europe nears sweeping pharma policy overhaul

European officials are racing to finalize a landmark overhaul of the E.U.'s pharmaceutical policies — the biggest in decades. It's aimed at improving access to medicines, while keeping the continent attractive to drugmakers, STAT's Andrew Joseph writes.

Negotiators are managing competing proposals from the European Commission, Parliament, and Council that would cut market exclusivity from the current 10 years to as little as eight. Industry officials argue shorter protection periods could drive investment to the U.S. and China — though proponents think these changes will speed generics and reduce inequality in access.

"The big thing that has yet to be resolved, and is something that's come into very, very sharp focus given the Trump administration's proposals on most-favored nation, is whether there's going to be an obligation to launch products, or whether there's going to be an obligation to seek pricing and reimbursement approval for products," said Grant Castle, the head of Covington's European life sciences regulatory practice.

special report

Telehealth's drug-first era rewrites medicine's playbook

What began with cheeky cactus ads for erectile dysfunction pills has exploded into a multibillion-dollar reinvention of telehealth — one that sells drugs first and care second.

When it comes to telehealth, startups like Hims and Ro turned virtual visits into Amazon-style storefronts for generics, and now, amid surging demand for GLP-1 weight loss drugs, the model has splintered into two rival camps: pharma-backed platforms dispensing branded meds, and compounding pharmacies marketing unapproved "personalized" blends.

Both are reshaping how Americans access — and pay cash for — prescriptions, STAT's Katie Palmer writes. It's fueling debate over whether telehealth's consumer revolution empowers patients or simply commodifies medicine.

obesity

Skye's CB1 receptor blocker fails in Phase 2 trial

Skye Bioscience said this morning that its investigational obesity drug failed to help patients lose significant weight in a mid-stage study, hampering the biotech's efforts to bring forward a drug with a controversial mechanism.

Patients taking the drug, called nimacimab, lost on average 1.5% of their weight over 26 weeks, but it wasn't a statistically significant result.

Skye said that their preliminary analysis showed lower than expected drug exposure, potentially indicating the need to test higher doses. It said its continuing to assess the data to determine possible next steps, including an additional Phase 2 study.

Still, the results cast doubt on the CB1 blocking mechanism and could raise questions about similar candidates in development by Novo Nordisk and Corbus Pharmaceuticals.

funding

TCGX closes $1.3 billion fund amid investor surge

Biotech investment firm TCG Crossover has closed its third fund at $1.3 billion, bringing its total raised since 2021 to more than $3.1 billion, it said this morning. The oversubscribed Fund III drew strong backing from endowments, pensions, and foundations.

The company closed its second fund in January 2024, raising $1 billion then. Some of its investments include radiopharmaceutical company RayzeBio, RNA player ADARx Pharmaceuticals, and Carmot Therapeutics, which was acquired by Genentech for $2.7 billion.

policy

Opinion: Tariffs threaten biosimilar progress and drug access

Pharma companies are racing to "onshore" manufacturing in the face of tariffs threatened by the Trump administration, but the policy could backfire by raising prices and undermining access to affordable medicines, opines Gillian Woollett, vice president and head of regulatory strategy and policy at Samsung Bioepis.

While domestic production might boost supply chain resilience, the concern is that forcing more of it through tariffs will discourage competition and drive inefficiency — particularly for generics and biosimilars, which already run on razor-thin margins. Biosimilars alone have saved the U.S. health system more than $56 billion, but new import tariffs could erode that advantage, stall innovation, and worsen global drug shortages, Woollett argues.

"Lessons from pandemics, natural disasters, and wars have shown that all stakeholders benefit from a global industry," she writes. "We want investments that create useful redundancy, and with it supply security, not ones that create duplicative costs."

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