Welcome to the Weekly Rundown where the DDN editors cover this week’s top biotech and pharma news.
BMS teams up with Anthropic to power drug discovery with AI
In a move that will scale AI to more than 30,000 employees, Bristol Myers Squibb (BMS) announced a partnership with Anthropic to deploy its AI platform Claude across its research, clinical development, manufacturing, commercial, and corporate functions. The company described the collaboration as a “meaningful evolution in how BMS deploys AI, moving beyond conversational tools that have defined the first wave of enterprise adoption, toward agentic capabilities built into the day-to-day workflows and systems that underpin its science and global operations.” BMS outlined three main priorities in the statement, including using Claude Code to accelerate engineering, embedding AI agents into existing drug discovery, development, manufacturing and commercial workflows, and integrating Claude into BMS’ “institutional knowledge.” Eric Kauderer-Abrams, Head of Life Sciences at Anthropic, said in the press release, “By giving employees access to Claude’s agentic capabilities — connected to thousands of data sources across the company — BMS is creating a single intelligence layer that can generate a clinical study report from underlying trial data, surface the right scientific context from decades of internal research, or trace the root cause of a manufacturing deviation in real time.” – Allison Whitten
Supreme Court pauses mifepristone mail restrictions
The US Supreme Court this week issued an emergency order temporarily blocking a Fifth Circuit ruling that would have eliminated mail-order access to mifepristone and reimposed in-person prescribing requirements overturned by the FDA in 2021. The case, brought by Louisiana Attorney General Liz Murrill against the FDA, cuts to a question with broader implications for drug developers: how much authority federal courts have to override FDA regulatory decisions on approved drugs. The Fifth Circuit's unanimous ruling effectively second-guessed the agency's 2021 determination that mifepristone could be safely prescribed via telehealth and dispensed by mail, a framework that has since become a model for expanded access to other medications. Manufacturers Danco and GenBioPro argued in their emergency petition that the lower court's decision introduced regulatory chaos into time-sensitive medical decisions. The Supreme Court's order keeps existing access in place for now, but full merits arguments remain ahead. For the drug development community, the case is worth watching as a test of judicial deference to FDA scientific and regulatory judgment — a principle with consequences well beyond reproductive medicine. – Andrea Corona
FDA approves AstraZeneca’s first-of-its-kind hypertension drug
AstraZeneca’s Baxfendy, a first-in-class aldosterone synthase inhibitor to treat hypertension, was approved by the FDA to lower blood pressure in patients who have been resistant to other medications. Baxfendy works by inhibiting the hormone aldosterone, known to be involved in raising blood pressure when it reaches high levels. The approval was based on positive results and generally tolerable safety findings from the Phase 3 BaxHTN trial. “We have been waiting for an innovative medication like Baxfendy for hypertension for many years. Its novel way of lowering blood pressure has the potential to transform clinical practice by targeting a root cause of persistently uncontrolled hypertension,” said Bryan Williams, a BaxHTN primary investigator at the University College London, in the press release. – Allison Whitten
A single dose of psilocybin cut cocaine use in a small trial
A randomized trial published this week in JAMA Network Open by researchers at the University of Alabama at Birmingham found that a single dose of psilocybin, combined with cognitive behavioral therapy, significantly reduced cocaine use in adults with cocaine use disorder — a condition for which no FDA-approved pharmacotherapy currently exists. Among the 40 participants, 30 percent of those who received psilocybin were fully abstinent from cocaine at 180 days, compared with none in the placebo group. Those who continued using did so far less frequently, averaging 1.5 uses per month versus 12 in the placebo group. The trial, more than a decade in the making and led by Peter Hendricks, was also notable for its participant pool: More than 80 percent were Black and 65 percent earned under $20,000 a year, a deliberate departure from psychedelic research norms in which participants are overwhelmingly white and college-educated. The study is small and replication in larger trials is needed before any clinical conclusions can be drawn, but for drug developers watching the psychedelics space, it adds to a growing body of evidence that psilocybin-assisted therapy may have meaningful applications beyond depression and post-traumatic stress disorder. – Andrea Corona
A nearly $900 million antitrust verdict against Takeda puts pay-for-delay patent deals back in the spotlight
A jury in the US District Court for the District of Massachusetts this week returned a verdict against Takeda in an antitrust case tied to its 2014 settlement with Par Pharmaceutical over the generic rights to AMITIZA (lubiprostone), a constipation drug the company no longer sells. The jury awarded plaintiffs nearly $885 million in single damages, which under US antitrust law will be automatically trebled for the wholesaler and retailer classes, potentially pushing total liability into the billions. Takeda is appealing. The case centers on a so-called pay-for-delay arrangement, in which branded drugmakers settle patent disputes with generic manufacturers by allowing delayed market entry — a practice permitted under the Hatch-Waxman framework but increasingly scrutinized by courts and regulators as anticompetitive. For drug developers, the verdict is a reminder that how companies structure patent litigation settlements carries long-term legal exposure, particularly as plaintiff attorneys and regulators continue to test the limits of what constitutes an anticompetitive deal. With Takeda planning to appeal, the case is far from settled, but the scale of the verdict alone is likely to prompt legal teams across the industry to take a harder look at how they negotiate generic entry timelines. – Andrea Corona
Merck and Kelun-Biotech score another win for their antibody-drug conjugate
On Monday, Merck announced that their antibody-drug conjugate (ADC) called sacituzumab tirumotecan (sac-TMT) became the first TROP2 (trophoblast cell-surface antigen 2) ADC to improve overall survival and progression-free survival compared to chemotherapy in patients with recurrent endometrial cancer. The drug, which was developed in collaboration with Kelun-Biotech, has already been approved in China for the treatment of breast cancer and lung cancer. The two companies have 17 global Phase 3 trials still in progress testing sac-TMT across a broad range of indications, and Merck previously received a National Priority Voucher that will speed up FDA review of sac-TMT after Merck submits the drug for approval. – Allison Whitten
