Good morning, everyone, and welcome to another working week, at least for those on our side of the pond, where we are returning from an extended holiday break. As usual this means that the predictable routine of online meetings and deadlines has returned. To cope, we are reaching for the tea kettle to have another cuppa. Our choice today is a blend of matcha, gingko, and a few berries. Please feel free to join us. Meanwhile, we have assembled a lengthy menu of items — a baker’s dozen, in fact — in hopes of easing your own journey today. Best of luck, and we hope you conquer the world. …

U.S. pharmaceutical companies are stepping up their campaign for higher drug prices in Europe, in some cases threatening to withhold new medicines if European lawmakers refuse, The Financial Times says. Pfizer chief executive Albert Bourla, the first pharmaceutical boss to announce a pricing agreement with President Trump last year, said the deal forced Pfizer to increase prices abroad. “When [we] do the math, shall we reduce the U.S. price to France’s level or stop supplying France? We [will] stop supplying France,” Bourla told reporters at the annual J.P. Morgan Healthcare Conference last week. “So they will stay without new medicines. The system will force us not to be able to accept the lower prices.” Other pharmaceutical executives said at the conference that they were quietly considering withholding or delaying drug launches in Europe.

Chinese drugmakers signed a record $135.7 billion in cross-border out-licensing deals in 2025, as global pharmaceutical giants raced to tap China’s growing drug pipeline, Nikkei Asia reports. The sector completed 157 such deals throughout the year, a sharp rise from the $51.9 billion across 94 deals recorded in 2024, according to Chinese data provider PharmCube’s NextPharma database. Pharmaceutical out-licensing typically grants overseas partners some or all of the rights to develop, manufacture, and commercialize a treatment originally developed by the licenser. The surge underscores China’s evolving role as a critical supply center for the global pharmaceutical industry, where multinational corporations are increasingly hunting for assets in fast-growing fields like antibody-drug conjugates and immunotherapy to offset looming patent cliffs, even as domestic firms grapple with the sustainability of these partnerships.

Continue to STAT+ to read the full story…

Rise and shine, everyone. The middle of the week is upon us. Have heart, though. You made it this far, so why not hang on for another couple of days, yes? And what better way to make the time fly than to keep busy. So grab that cup of stimulation — our flavor today boasts the aroma of blueberries — and get started. Meanwhile, do keep us in mind if you hear anything interesting. Have a smashing day…

In a closely watched case, the U.S. solicitor general urged the Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of lower-cost generic drugs, STAT tells us. Skinny labeling refers to a process in which a generic drug company seeks regulatory approval to market its medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem, but not another. In doing so, the generic company seeks to avoid lawsuits claiming patent infringement. Doubts were raised about the maneuver, however, when the Supreme Court two years ago declined to hear an appeal of a lower court ruling, which questioned the practice. Now, this second case is being seen as a test for whether skinny labeling can survive as a way for generic companies to market medicines.

The U.S. Food and Drug Administration is on track to make it harder for CAR-T therapy developers to bring their products to market by making full randomized, controlled trials the new standard it will accept for regulatory filings, Pharmaphorum writes. At the moment, it has been possible to develop CAR-Ts based on single-arm trials, although some have used an active comparator. Now, with the number of CAR-Ts on the market now in double figures, the FDA is eyeing RCTs with a control group as well as “a survival or acceptable time-to-event endpoint.” The move towards a higher threshold for showing efficacy for new CAR-Ts comes after the FDA loosened requirements for safety monitoring by eliminating the risk evaluation and mitigation strategies previously required for already-marketed therapies targeting CD19 and BCMA, which the agency said would make them more accessible.

Continue to STAT+ to read the full story…