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Pharmaceutical Innovations and Regulatory Milestones: A Snapshot of Recent Industry Developments

Swiss pharmaceutical company Ferring Pharmaceuticals reported Wednesday that its bladder cancer treatment Adstiladrin generated revenues of approximately 70 million euros ($77 million) during its first complete year of sales in the United States. The gene therapy treatment, which is administered directly to bladder cells, received FDA approval in late 2022 but wasn’t widely available until January 2024. The company continues to expand its manufacturing capabilities to meet demand for the therapy, which it considers a key growth driver for future business expansion.

In other industry developments, biotech firm Solu Therapeutics announced successful completion of a Series A financing round, raising $41 million. The company also revealed it has begun dosing patients in a Phase 1 clinical trial targeting blood cancers, including
resistant/refractory chronic myelomonocytic leukemia. The newly secured funding will support development of additional experimental treatments, including a mast cell depletor for immune disorders. Solu Therapeutics, which emerged from Longwood Fund in 2023 with $31 million in seed funding, operates with technology and drug candidates licensed from GSK.

A coalition of 96 organizations, led by the American Society of Hematology, has formally petitioned Health and Human Services Secretary Robert F. Kennedy Jr. to reverse the dismantling of the CDC’s Division of Blood Disorders and Public Health Genomics. In their Tuesday letter, the groups warned of “severe and irreversible consequences” if the division, which coordinates with states and healthcare providers on blood disorder management, is not immediately restored following recent HHS budget cuts.

Bristol Myers Squibb achieved a significant regulatory milestone with FDA approval of its cancer immunotherapy combination, Opdivo and Yervoy, for first-line treatment of certain colorectal cancers. The approval, which came more than two months ahead of schedule, specifically targets microsatellite instability-high or mismatch repair deficient disease that is either inoperable or has
metastasized. Clinical trial data showed the combination therapy reduced disease progression or death risk by 79% compared to chemotherapy in previously untreated patients, and by 38% across all study participants, including those who had received prior treatment. Opdivo was previously approved as a monotherapy for this cancer type in patients whose disease progressed after chemotherapy.

In corporate developments, PureTech Health’s potential acquisition by Nordic Capital has fallen through after PureTech’s board rejected the private equity firm’s offer. The biotechnology incubator, known for launching successful ventures like Karuna Therapeutics and Seaport Therapeutics, issued a statement Monday regarding negotiations with Nordic Capital, giving the firm 28 days to clarify its intentions. Nordic Capital promptly responded with its own statement confirming the end of acquisition discussions. This marks PureTech’s second unsuccessful merger attempt, following collapsed talks with Nektar Therapeutics in 2022.

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