Today, a brief rundown of news from Boehringer Ingelheim and BioMarin Pharmaceutical, as well as updates from Pfizer and Novartis that you may have missed.
The Food and Drug Administration has granted its second approval under the “national priority” program meant to significantly shorten drug reviews, clearing Boehringer Ingelheim’s Hernexeos on Thursday for a form of lung cancer. Boehringer was awarded a special voucher from the FDA on Nov. 6 and filed an application on Jan. 13. A decision was made 44 days later. In a statement, the FDA called the 76% response rate to Hernexeos among patients with untreated, HER2-mutated lung cancer “remarkable” and a “significant improvement” over the standard of care. So far, the FDA has awarded around 18 vouchers through its program, which has drawn controversy and alarmed some senior leaders. The first approval, for a decades-old antibiotic, came in December. — Ben Fidler
Boehringer also acquired an exclusive license from Boston-based Sitryx Therapeutics for an early-stage oral therapy with potential to treat a range of autoimmune diseases. As part of the deal announced Thursday, Sitryx is eligible to receive over $500 million total consisting of an upfront payment and milestone payments. The company is also eligible for tiered royalties on approved products. Boehringer will now run clinical research, development and commercialization for the preclinical stage program. — Delilah Alvarado
Biomarin Pharmaceutical has officially withdrawn from market its hemophilia A gene therapy Roctavian. In an earnings report this week, BioMarin said a “comprehensive effort” that began in October failed to unearth a “qualified buyer” for Roctavian, leading the company to pull it altogether. Roctavian’s approval in Europe in 2022 and in the U.S. a year later were scientific milestones and the culmination of years of research in developing a genetic medicine for the chronic blood condition. But uptake was sluggish amid doubts about Roctavian’s benefits and price tag, leading the company to sharply slash sales forecasts and, last year, opt to divest it altogether. BioMarin isn’t alone; Pfizer in 2025 also cited weak demand in choosing to stop selling a gene therapy for hemophilia B. — Ben Fidler
Viatris is laying off 10% of its staff in a restructuring the company said should deliver $600 million to $700 million in annual cost savings, the company said Thursday. The layoffs are expected to take place over the course of the next three years and will involve cuts in multiple areas, including Viatris’ sales force and research and development teams. Viatris has more than 30,000 employees, according to a regulatory filing. — Ben Fidler
Novartis said Wednesday it will be expanding its radiotherapy manufacturing with a new facility to be established in Denton, Texas. The new 46,000-square-foot radioligand therapy site is a part of the company’s $23 billion investment pledge made amid tariff turmoil and pressure from the Trump administration to bring manufacturing to the U.S. The new site will be the company’s fifth radiotherapy manufacturing plant in the U.S., with construction expected to begin this year and become fully operational by 2028. — Delilah Alvarado
Pfizer on Tuesday won a full U.S. clearance for a drug combination that in clinical testing helped cut in half the risk of disease progression or death in people with untreated, metastatic colon cancer. The regimen, which adds Pfizer’s Braftovi to two standard therapies, was granted an accelerated nod in late 2024 in colorectal cancer patients with a specific mutation to the BRAF gene. Pfizer has since confirmed the benefits in the study, “Breakwater,” underlying that approval. The company secured Braftovi in an $11.4 billion buyout of Array Biopharma in 2019. — Ben Fidler
