Today, a brief rundown of news involving Bristol Myers Squibb and the Food and Drug Administration, as well as updates from DiaMedica Therapeutics, GSK and PureTech Health that you may have missed.
An anemia treatment from Bristol Myers Squibb failed to meet its primary goal in a Phase 3 study of people with low blood cell counts due to myelofibrosis, the company said Friday. Even so, treatment with the drug, Reblozyl, did lead to what Bristol Myers described as a “numerical and clinically meaningful” improvement in the proportion of patients who achieved independence from red blood cell transfusions, compared to those given placebo. Bristol Myers said it was “encouraged” by these data and other supportive secondary measures, and plans to talk with regulators about submitting an approval application. Reblozyl is currently cleared for use treating anemia in certain patients with beta thalassemia and myelodysplastic syndromes. — Ned Pagliarulo
Advisers to the Food and Drug Administration were not convinced GSK’s multiple myeloma drug Blenrep should return to the U.S. market, voting Thursday that data from two trials of the drug did not show a favorable benefit-risk balance for the patient population GSK proposes to treat. In briefing documents ahead of Thursday’s advisory committee meeting, FDA staff had outlined concerns around Blenrep’s dosing and eye toxicity. The agency will decide whether to approve Blenrep by July 23. The antibody-drug conjugate was previously withdrawn from market in 2022 after an earlier confirmatory study failed. — Ned Pagliarulo
Minneapolis-based biotechnology company DiaMedica Therapeutics on Thursday announced early results from a mid-stage study of a treatment it’s developing for preeclampsia. The treatment, called DM199, “achieved pre-specified safety and efficacy endpoints” in the dose escalation phase of DiaMedica’s Phase 2 study, the company said. A pregnancy-related disorder, preeclampsia can cause high blood pressure and is potentially dangerous to both the mother and fetus. There are no approved pharmaceutical treatments. DiaMedica plans to enroll as many as 90 women with preeclampsia and 30 women with fetal growth restriction in its trial. — Delilah Alvarado
The Food and Drug Administration on Thursday approved a pre-filled syringe formulation of GSK’s Shingrix shingles shot. Currently, the vaccine comes in two vials that healthcare professionals must combine prior to administration — a step the single syringe will remove. The approval applies to Shingrix’s prior indication in adults aged 50 years and older, as well as immunocompromised individuals aged 18 years and older who are at high risk of the disease. The European Medicines Agency is also reviewing the pre-filled syringe formulation. — Delilah Alvarado
PureTech Health announced Wednesday that CEO Bharatt Chowrira has stepped down from his role leading the biotech company. Chowrira’s exit comes one week after the departure of PureTech board chair Raju Kucherlapati. PureTech said Chief Portfolio Officer Robert Lyne will serve as interim CEO; it did not share further details about plans to search for a permanent successor. Chowrira became PureTech’s head after founding CEO Daphne Zohar left to run PureTech-launched Seaport Therapeutics in April 2024. — Ned Pagliarulo
