July 24, 2026

The need-to-know this morning

Different leadership, different plans: Sanofi, under new CEO Belén Garijo and new R&D head Paulo Fontoura, said it was dropping amlitelimab as an atopic dermatitis drug. The drug had produced lackluster trial results, but it had been a key component of the previous leadership team's strategy, and the company said as recently as January that it planned to submit the drug to regulators. But today, the company said that the drug "would not represent a meaningful improvement to the standard of care." Sanofi continues to test the drug in a Phase 2 celiac disease study.
Fresh off filing a lawsuit against rival Eli Lilly over a Lilly ad campaign for its obesity and diabetes drugs, Novo Nordisk has now asked the court to halt the ads while the case proceeds. Lilly said when the case was filed that it stood behind the campaign, calling it "truthful" and "transparent."
Merck reached voluntary licensing deals with seven companies to make generic versions of an experimental, once-a-month HIV prevention pill in 129 low- and middle-income countries.

peptides

FDA panel narrowly backs broader peptide access

An FDA advisory committee voted Thursday to recommend allowing compounding pharmacies to produce the peptides BPC-157 and KPV. This comes despite FDA staff urging against it because of limited evidence on their safety and effectiveness, STAT’s Sarah Todd and Lizzy Lawrence write. The split votes highlighted growing tensions between career regulators and a panel stacked with members who have financial ties to the peptide industry.

Broader access could steer patients away from potentially dangerous grey-market products, proponents say. But the decision could be read as an FDA endorsement of compounds that remain poorly studied — and could lend legitimacy to increasingly popular but unproven wellness treatments.

“I would really encourage the FDA to standardize how these things are measured and how the decision-making should be made,” Brian Lee, a USC researcher and panel member, said after voting against lifting restrictions on BPC-157. “Really the decision should be objective and based on facts, not subjective and based on opinion.”

gene editing

Fatal gene-editing trial in China raises ethics and oversight questions

A 6-year-old girl died last year after receiving the world's first brain-directed CRISPR base-editing therapy in an experimental trial in China. The trial exposes serious lapses in oversight, transparency, and informed consent, Science and Retraction Watch report.

The animal safety data leading up to the trial was troubling. Regulatory scrutiny was limited, and the girl’s death went undisclosed for more than a year. Her parents are now seeking accountability: the hospital conducting the study only received only a modest fine, and a related — and lauded — Nature paper omitted the fatal outcome and the family's role in funding the research. The family wants the Nature paper retracted, “to prevent more children from suffering and our blood and tears flowing in vain,” they told Science.

“I don’t think these kinds of experiments should stop, but we need to make sure we are appropriately careful about them,” Stanford bioethicist Hank Greely said. “It’s so easy to be blinded by hope — whether it’s hope for your kid, hope for your research, or hope for your company.”

transparency

EMA pushes for greater disclosure of clinical trial results

The European Medicines Agency is moving quickly to strengthen clinical trial transparency after an analysis found that fewer than half of studies in its Clinical Trial Information System reported results on time, STAT’s Ed Silverman writes. Only 42% fully reported their findings.

Regulators have begun notifying sponsors when results are due and have created dashboards to track overdue trials. They plan to update guidance and publicly report compliance rates by the end of the year.

Advocates like Till Brückner, a co-author of the study and research fellow at Karolinska Institutet in Stockholm, praised the unusually swift response.

“We have never before seen a regulator respond so positively, decisively and rapidly to a campaign,” he wrote in a blog post.

supply chain

Drug supply resilience needs stronger domestic oversight

Vulnerabilities in the U.S. drug supply chain are not as driven by dependence on China as it seems, opines NYU researcher Pooja Yerramilli, who has worked at the WHO and World Bank to improve access to health care. Instead, these holes are from longstanding weaknesses in domestic regulation and health policy, she says.

Calls to onshore or "friend-shore" pharmaceutical manufacturing have gained traction as a national security strategy. But those efforts will fall short without stronger FDA oversight, sustained NIH funding, and broader reforms to improve drug affordability.

“Our pharmaceutical supply chain resilience will not come from a siloed focus on geopolitics,” Yerramilli writes. “It will come from regulatory reforms that safeguard our collective health above corporate profit.”

insulin

Popular insulin pen in short supply

Patients who rely on Sanofi’s Lantus SoloStar insulin pen are encountering widespread supply problems, STAT’s Isabella Cueto writes. This is forcing many to call multiple pharmacies or switch medications, even though the FDA has not formally declared a shortage.

Sanofi attributed the disruption to increased demand driven by broader market shifts, including the discontinuation of competing long-acting insulin products such as Novo Nordisk’s Levemir and Biocon’s branded Semglee pen. Pharmacists say switching patients is often complicated by insurance rules and the need for new prescriptions.

“Patients with diabetes are so used to being jostled around,” Shaina Kasper, executive director of T1International, told STAT. “Going just a few hours without insulin can be hugely problematic and can lead to significant complications.”

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