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What’s in Today’s Brief? (May 5th Preview)
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Regulators move toward real-time signal sharing in early trials
The FDA launched a pilot program for real-time clinical trials (RTCTs) intended to accelerate early-phase development by letting sponsors report safety signals and endpoint data as trials progress. The agency described RTCT pilots with AstraZeneca and Amgen, including technical validation of signal sharing for an AstraZeneca study via Paradigm Health. In its announcement, FDA said it met with both sponsors before initiation to define reporting criteria for signals, aiming to reduce the lag time that can delay regulatory decisions. FDA Commissioner Marty Makary and FDA Chief AI Officer Jeremy Walsh framed RTCTs as a modernized way for regulators to see safety information sooner. The agency also opened a request for information for an additional pilot program, seeking industry input through the end of May. FDA plans to disseminate final selection criteria in July and complete pilot selections in August, indicating a near-term rollout path for broader participation.
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FDA access restored for mifepristone via telemedicine and mail
The U.S. Supreme Court temporarily reinstated online access to the abortion pill mifepristone by mail, pausing a federal appeals court ruling that had blocked prescribing by phone and through the mail. The stay runs through May 11 while the court considers further action. Manufacturers Danco and GenBioPro sought emergency relief, arguing the appeals court order created regulatory chaos and disrupted orderly administration of the drug. The decision also allows patients with existing appointments to avoid treatment interruptions. The lower-court action stemmed from a lawsuit filed by Louisiana seeking reinstatement of an FDA in-person consultation requirement. Federal availability of telemedicine for mifepristone was lifted in 2021 during the COVID-19 pandemic.
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Big pharma reshuffles US commercial workforce
Novartis added another wave of US job cuts tied to its East Hanover headquarters, according to a WARN filing. The company said it will lay off about 60 roles later this year, separate from a prior US headquarters reduction plan announced in March. Novartis linked the changes to efforts to evolve oncology, rheumatology, dermatology, and neuroscience field sales teams in the US. The new reductions are scheduled to begin in late July and run through late November, wrapping two separate layoff cycles. The move lands as Novartis faces pressure from a 2026 patent cliff and continues preparing launches in rare kidney disease, while also adapting commercial structures for rare disease medicines.
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New immuno-oncology platform funding: gamma delta T-cell engager push
Cytospire raised £61 million (about $83 million) in a Series A to advance CYT X300, its gamma delta T-cell engager program for solid tumors. The London-based biotech said it plans early testing in EGFR-positive solid tumors including colorectal, head and neck, and non-small-cell lung cancer. The company’s CEO Natalie Mount said gamma delta T cells are already present in the tumor microenvironment and may deliver stronger tumor-selective activity than other T-cell subsets. She also framed CYT X300 as designed to be delivered in a biologic format familiar to large pharma and scalable for broader patient access. Cytospire’s lead program has yet to enter human studies, and the company pointed to participation by Abingworth and a Series A lead led by 4BIO Capital, with additional involvement from Servier’s venture arm.
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Oncolytics updates durability in REO 022 and weighs accelerated approval strategy
Oncolytics Biotech reported updated Phase 1/REO 022 efficacy data for pelareorep (Reolysin) in combination with bevacizumab and FOLFIRI in second-line RAS-mutant microsatellite-stable metastatic colorectal cancer. The update showed a median duration of response of 19.5 months and an overall response rate of 33% in KRAS-mutant MSS mCRC. The company positioned the longer response tail relative to historical standard-of-care benchmarks, and said it is discussing a potential accelerated approval pathway with the FDA. Oncolytics CEO Jared Kelly stated the durability signal supports engagement on a regulatory strategy leveraging the company’s ongoing randomized study. The trial enrolled adults with measurable disease, confirmed KRAS mutations, ECOG 0–2, and prior oxaliplatin exposure, with key exclusions including prior metastatic irinotecan/FOLFIRI use.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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