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What’s in Today’s Brief? (June 15th Preview)
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Regulatory change in EU clinical trials
The European Medicines Agency (EMA) said it is preparing for major Clinical Trials Regulation updates tied to the incoming EU Biotech Act, including system changes to the Clinical Trials Information System (CTIS). EMA framed the shift as part of an effort to speed assessments, reduce administrative burden, and improve patient access to innovative therapies. EMA also said the Biotech Act would modify how ongoing studies can be adjusted, giving sponsors and CROs more flexibility once the legislation takes effect later this year. The regulator noted that the European Commission proposed the Biotech Act in December 2025 and solicited feedback before adoption. The agency added that it will allocate resources to update systems ahead of the effective date and enhance CTIS functionalities to support streamlined clinical trial applications under the single-submission model.
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Phase 3 momentum and label expansion in multiple myeloma
Johnson & Johnson scored positive Phase 3 results for Talvey (talquetamab-tgvs) when paired with Darzalex Faspro (daratumumab and hyaluronidase-fihj), with data presented in the New England Journal of Medicine and at the European Hematology Association meeting. The combination reduced risk of disease progression or death and showed a significant reduction in mortality versus the standard regimen in relapsed or refractory multiple myeloma. J&J said the regimen cut risk of death by up to 53% after two years and reduced progression-or-death risk by up to 72%, positioning the data as evidence of superior progression-free survival in earlier-line disease. Talvey is a GPRC5D-targeting CD3 bispecific antibody approved for heavily pretreated patients. The company said it is now working with regulators to expand Talvey’s label in the U.S. and Europe, as it continues efforts to grow its blood-cancer franchise while other products face competitive pressure.
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FDA-linked product and reimbursement policy changes for Medicare
A new Medicare demonstration pathway would make weight-loss drugs available to adults 65 and older for the first time next month, bypassing a legal prohibition on direct Medicare payment for obesity medications. The program is designed to be temporary but could be hard to unwind, according to STAT+. STAT+ reported that initial Medicare plans to rely on private Medicare insurers under a three-year BALANCE program were rejected as insurers balked. The government instead extended a transitional coverage program, called Bridge, until the end of next year. Separately, a proposed federal Medicare price-negotiation rule could also reshape how under-the-skin versions of blockbuster cancer immunotherapies are handled, potentially affecting how biosimilar competition intersects with pricing later in the decade.
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Takeda’s AI-designed psoriasis pill outperforms Sotyktu in Phase 3
Takeda reported that its AI-designed oral psoriasis candidate zasocitinib achieved complete skin clearance in more than 35% of patients at 16 weeks in a Phase 3 study, outperforming Bristol Myers Squibb’s Sotyktu comparator. Takeda said the response rate was more than 2.5 times that of patients receiving Sotyktu in the study. The company reported efficacy separation as early as week 8 and also beat Sotyktu on key secondary outcomes including PASI 90. Takeda said the data support regulatory filing plans in coming months. Takeda previously acquired zasocitinib from Nimbus Therapeutics for $4 billion and has been positioning the TYK2-targeting, IL-23-inhibiting approach to deliver rapid and durable clearance in a convenient once-daily pill.
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Setback in Phase 3 depression program and layoffs
Neumora Therapeutics reported that navacaprant failed to achieve statistical significance in two additional Phase 3 trials for major depressive disorder, Koastal-2 and Koastal-3. With the clean sweep of late-stage misses, the company said it would discontinue development of the program and prepare to cut 35% of its staff. In the trials, Neumora reported navacaprant did not significantly outperform placebo on the change in Montgomery–Åsberg Depression Rating Scale (MADRS) scores by week 6; in Koastal-3, placebo performed better on the depression score measure. The company said it expects the reorganization to deliver $10 million in annual savings and extend its cash runway into the third quarter of 2027. The update narrows the pipeline to other late-stage and early programs, including NMRA-511 for Alzheimer’s disease agitation, NMRA-898 for schizophrenia, and NMRA-215 in obesity.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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