Pharmaceutical Industry Roundup: Mixed Results for Bristol Myers and GSK, Leadership Changes at PureTech

Bristol Myers Squibb's Reblozyl Falls Short in Phase 3 Trial

Bristol Myers Squibb announced that its anemia treatment, Reblozyl, failed to meet its primary goal in a Phase 3 study for patients with myelofibrosis-related anemia. Despite this setback, the company reported a "numerical and clinically meaningful" improvement in patients achieving independence from red blood cell transfusions compared to placebo. Bristol Myers remains optimistic about the drug's potential and plans to discuss possible approval applications with regulators.

Reblozyl is currently approved for treating anemia in certain patients with beta thalassemia and myelodysplastic syndromes. The company's pursuit of an expanded indication for myelofibrosis underscores its commitment to addressing unmet needs in hematological disorders.

GSK Faces Hurdles for Blenrep's Market Return

GSK's efforts to reintroduce its multiple myeloma drug Blenrep to the U.S. market encountered a significant obstacle as FDA advisers voted against the drug's benefit-risk profile. The advisory committee's decision was influenced by concerns surrounding Blenrep's dosing and eye toxicity, as outlined in FDA staff briefing documents.

Blenrep, an antibody-drug conjugate, was previously withdrawn from the market in 2022 following the failure of an earlier confirmatory study. The FDA is set to make a final decision on Blenrep's approval by July 23, but the negative advisory committee vote may complicate its path back to patients.

In more positive news for GSK, the FDA approved a pre-filled syringe formulation of its Shingrix shingles vaccine. This new presentation eliminates the need for healthcare professionals to combine two separate vials before administration, potentially streamlining the vaccination process. The approval applies to adults aged 50 and older, as well as immunocompromised individuals aged 18 and older who are at high risk of shingles.

Industry Leadership Changes and Clinical Developments

PureTech Health announced the departure of CEO Bharatt Chowrira, with Chief Portfolio Officer Robert Lyne stepping in as interim CEO. This leadership change comes just one week after the exit of PureTech board chair Raju Kucherlapati. The company has not yet disclosed plans for a permanent successor to Chowrira, who had taken the helm following the departure of founding CEO Daphne Zohar in April 2024.

Meanwhile, DiaMedica Therapeutics reported encouraging early results from a Phase 2 study of DM199, its investigational treatment for preeclampsia. The company stated that the drug "achieved pre-specified safety and efficacy endpoints" in the dose escalation phase of the trial. With no currently approved pharmaceutical treatments for preeclampsia, a potentially dangerous pregnancy-related disorder, DiaMedica's progress in this area could represent a significant advancement in maternal-fetal medicine.