German company Tubulis GmbH, which emerged with a $12.3 million series A round and a next-generation antibody-drug conjugate (ADC) platform about six years ago, has commanded up to $5 billion in a buyout offer from Gilead Sciences Inc.

After nearly a year of threats and promises of a global biopharma tariff of 25% to 500%, U.S. President Donald Trump finally delivered it. In the name of national security, he imposed a 100% sector tariff on prescription drugs and their associated ingredients beginning in about four months for large manufacturers and six months for smaller companies.

Swedish startup One-carbon Therapeutics AB is going after solid tumors with an approach that looks similar to synthetic lethals to some people, and to chemotherapy to others. But One-carbon CEO Ana Slipicevic said that TH-9619, the company’s first-in-class inhibitor of the enzyme MTHFD1/2, is neither of those things.

After nearly a year of threats and promises of a global biopharma tariff of 25% to 500%, U.S. President Donald Trump finally delivered it. In the name of national security, he imposed a 100% sector tariff on prescription drugs and their associated ingredients beginning in about four months for large manufacturers and six months for smaller companies. However, depending on the drug, where it’s made and whether a manufacturer has reached onshoring and pricing agreements with the Department of Health and Human Services, the actual tariff could be as low as 0%.

Chiesi Group’s idebenone faced a regulatory setback last month after the U.S. FDA issued a complete response letter (CRL) to the company’s NDA for Leber hereditary optic neuropathy (LHON), a rare inherited disorder that causes sudden vision loss.But a chance missed for Chiesi may be an opportunity for gene therapies, including Gensight Biologics SA’s lenadogene nolparvovec (Lumevoq; GS-010).

The EMA has given initial endorsement to a new approach to early toxicity testing in which live animals will be replaced by virtual counterparts. The virtual control groups will be derived from data generated in animals that have been used as controls in previous studies. The historical database has been brought together in an EU-funded project to which 20 pharma and crop sciences companies contributed. While limited in scope, this is the first time the EMA has formally endorsed the use of a new approach methodology (NAM) to generate data that could eventually be included in an application for marketing approval.

Wegovy (semaglutide) has passed the notoriously strict cost-effectiveness scrutiny of the U.K. health technology assessment body and will now be reimbursed for the prevention of further serious cardiovascular events in people who have had a heart attack or stroke, or are diagnosed with peripheral arterial disease.

With cases of peripheral artery disease (PAD) rising across the U.K., and lower limb amputations continuing to increase, med-tech companies joined forces with parliamentarians and health care professionals to push for urgent reform of the vascular sector.

Once again, Amgen Inc.’s Tavneos (avacopan) is under U.S. FDA scrutiny, as the agency alerted patients and doctors March 31 about 76 cases of drug-induced liver injury, including eight deaths, with “reasonable evidence of a causal association” with the drug.

Galapagos NV is about to bury its recent turbulent past and sail off for the future with its $3 billion cash pile and the new name of Lakefront Biotherapeutics NV. The foundation for the transition was laid earlier this month in an arrangement with Gilead Sciences Inc., holder of 25% of Galapagos’ equity, to “co-parent” the assets of Ouro Medicines LLC, which Gilead is acquiring for up to $2.17 billion.