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Mergers and acquisitions are common in clinical research, requiring flexibility and agility. When a sponsor changed mid-trial, Premier seamlessly maintained regulatory compliance, patient safety, and data integrity.
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Today’s Big NewsNov 5, 2024 |
| By Nick Paul Taylor Beam Therapeutics has presented the first clinical data on its base editing technology. All four sickle cell disease patients in the efficacy cohort had fetal hemoglobin levels above Beam’s target—and the result achieved by Vertex’s rival therapy—but one patient died, likely as a result of the conditioning regimen. |
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By James Waldron Sana Biotechnology has become the latest cell therapy biotech to shift resources from cancer to autoimmune diseases, as part of a strategic refocus that sounds likely to include a side order of layoffs. |
By Zoey Becker Americans are already casting votes for the next president, but questions around drug pricing and the pharma industry will likely loom after the winner is decided. |
Sponsored by Dell Technologies While artificial intelligence is on everyone’s minds and in many R&D plans, adoption of generative AI has been slow so far in life sciences. |
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Create an optimal path to the clinic that best suits your molecule and critical milestones. We now offer a full suite of integrated drug substance/drug product DNA-to-IND programs to accelerate any molecule type to the clinic. Download our white papers to learn more about our tailored CMC strategies.
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By Nick Paul Taylor The FDA has scuttled Merus’ plans to win a speedy approval for its solid tumor drug zenocutuzumab. On the cusp of the priority review deadline, the agency has pushed back the decision date by three months to give its staff more time to assess recently submitted information. |
By James Waldron Cellectis has deprioritized one of its leukemia-focused candidates in order to focus on its other two clinical-stage CAR-T therapies. |
By Gabrielle Masson Swiss biotech Relief Therapeutics is slated to enter a reverse merger with private U.S. biotech Renexxion and forge ahead with the latter’s gastrointestinal pipeline. |
By Darren Incorvaia Spanish biotech Integra Therapeutics has upped its arsenal of gene editing tools by licensing Caszyme’s Cas12I nucleases, the company announced Nov. 4. |
By Paige Minemyer Spending on GLP-1s in Medicaid has followed broader industry trends, growing significantly over the past several years, according to a new study from KFF. |
By Ben Adams With the FDA approval of the first specific drug for Metabolic Associated Steatohepatitis (MASH) in March this year, Madrigal’s Rezdiffra is a pioneer in a market set for rapid change. |
Fierce podcastsDon’t miss an episode |
| | This week on "The Top Line," we explore how each presidential candidate’s approach to drug pricing could shape future policy. |
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On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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