Multiple sources said Marty Makary was behind a short-lived request to reject a rare disease drug application from KalVista Pharmaceuticals, Endpoints’ Andrew Dunn reported this week. Senior FDA scientists pushed back internally and raised legal concerns, he reported. Academic and legal experts weighed in here.

Andrew Nixon, HHS director of communications, said in a statement that the claim that FDA leadership requested a CRL for KalVista’s drug is “totally false and untrue.” He said the drug’s review “is still ongoing, and the FDA will ensure the gold standard of science is used for all decisions.”

KalVista announced on June 13 that it had been informed that the agency would not meet its review target for the company’s hereditary angioedema treatment, sebetralstat, “due to heavy workload and limited resources.” KalVista has since said in a statement that the company was unaware of “any internal deliberations at the FDA and we do not comment on rumors.”

“We continue to have productive engagement with the FDA and remain focused on the goal of bringing this important new therapy to people living with HAE,” the company said. You can read more here. 

The agency said it will investigate the deaths after Sarepta reported earlier this month that a second patient died due to liver failure. The patient, a 15-year-old boy, died after being administered the gene therapy Elevidys. The patient was non-ambulatory, meaning he couldn’t walk independently, which is typically seen in older Duchenne patients with more advanced disease. He was participating in Sarepta’s confirmatory clinical trial for the treatment, which was first approved in 2023 for children aged 4 and 5 before getting an expanded approval for older individuals last year.

Sarepta has said it would take steps to mitigate future deaths and safety events. The company said this month that it would pause the shipping of Elevidys to non-ambulatory Duchenne patients and stop administering it to such individuals in its confirmatory study. In order for dosing to resume, “regulatory alignment” is needed, Sarepta said.

Currently, Elevidys’ prescribing information includes the risk of serious liver injury. But it notably does not include a warning for liver failure or death. It’s not yet clear whether Sarepta will need an updated label. The other patient who died earlier this year, a 16-year-old who got the therapy commercially, was also non-ambulatory.

Our reporters covered a handful of deals this week, including Gilead’s agreement with Kymera Therapeutics for a partnership that focuses on degrading CDK2. CDK2 is implicated primarily in breast cancer but also other solid tumors. Kymera will conduct research, and Gilead will have the option to exclusively license the program.

The partners didn’t disclose the upfront payment, but said the upfront and option exercise payments are worth up to $85 million. Kymera can receive up to $750 million in total.

Meanwhile, Novartis struck a deal with the proteomics specialist ProFound Therapeutics focused on the cardiovascular space. Under the four-year partnership, Novartis will pay $25 million in upfront and near-term milestones.

Illumina has agreed to pay $350 million upfront to acquire proteomics player SomaLogic, in a deal that builds on a yearslong partnership between the companies. Vor Bio said it inked a deal featuring $45 million in cash to license a BAFF/APRIL inhibitor called telitacicept from China’s RemeGen, and announced it’s raising $175 million in a private placement. And biotech correspondent Kyle LaHucik detailed how a dinner in Paris set the stage for Sanofi's $9.5B deal for Blueprint Medicines earlier this month.

Novo Nordisk, which sells the diabetes and weight loss drug semaglutide, abruptly canceled its deal with Hims & Hers after less than two months. The deal had allowed Hims to offer compounded versions of semaglutide — the main component of Ozempic (diabetes brand) and Wegovy (weight loss) — at a discounted price. Hims has been a provider of compounded semaglutide, making it a competitor to Novo.

But the relationship soured quickly. Novo accused Hims of “fail[ing] to adhere to the law” and offering “illegitimate” and “knockoff” versions of Wegovy. Hims accused Novo of anticompetitive practices and said it was pressured to sell brand-name Wegovy regardless of whether it was best for patients. A Novo spokesperson declined to say what legal action, if any, the company might take against Hims. Read more from our Health Tech team here.

The annual meeting for the American Diabetes Association took place in Chicago this week, and our senior biopharma journalist Elizabeth Cairns broke down some of the biggest readouts and updates presented at the conference. The biggest news? A major update from Vertex, saying its cell therapy for type 1 diabetes allowed 10 of 12 patients (83%) to stop taking insulin a year after they were infused.

Other news from the confab included data from the Phase 1/2 obesity trial of Novo’s amycretin, which saw a puzzling lack of dose response. There were also updates from Eli Lilly’s orforglipron, Sciwind Biosciences’ ecnoglutide and Novo Nordisk’s CagriSema. And Amgen said it’s planning lower and slower doses of its long-acting shot MariTide.