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Pharma and BioTech Daily

Pharma and BioTech Daily

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This podcast aims to bring you a daily summary of the most relevant news in Pharma and BioTech. Check our website at: https://www.buzzsprout.com/2189790

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Episodios
  • Pharma & Biotech Daily: FDA Leadership Turnover and Industry Challenges

    Pharma & Biotech Daily: FDA Leadership Turnover and Industry Challenges
    Jun 24 2025
    Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. The FDA's Center for Drug Evaluation and Research (CDER) head, Jacqueline Corrigan-Curay, is leaving the agency in July, becoming the latest in a series of FDA leaders to depart. Eli Lilly is facing concerns about gastrointestinal side effects for their weight loss pill, Orfoglipron, despite brushing off these worries. Vertex's cell therapy for diabetes shows promise, but questions remain about its market potential. HHS Secretary Robert F. Kennedy Jr. has restacked the CDC's vaccine advisory committee, claiming conflicts of interest within the previous group, which experts argue may impact the committee's apolitical nature. Prothena has downsized following a failure in an Al amyloidosis trial, and Novavax is adapting to regulatory uncertainty. Overall, the FDA is experiencing significant turnover in leadership, and challenges persist in drug development and regulation.
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    1 m
  • Navigating Regulatory Uncertainty: Updates from the Pharma and Biotech World

    Navigating Regulatory Uncertainty: Updates from the Pharma and Biotech World
    Jun 23 2025
    Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Nicole Verdun has exited the FDA as CBER director, allowing Vinay Prasad to consolidate power within the agency. Prasad is seen as a stabilizing and trustworthy figure within the rapidly changing FDA, especially since the departure of Peter Marks in late March. Novavax is adapting to regulatory uncertainty following the delayed approval of its next-generation COVID-19 vaccine. The company is relying on agility and a diverse pipeline to navigate changing regulations. Additionally, the FDA has frozen trials shipping cells to countries like China due to new export control policies. Exemptions have allowed companies to ship biological materials overseas, but this practice is now being restricted. Zealand's GLP-1/GLP-2 drug has shown promising results in weight loss trials, with analysts believing there is potential for further improvement. Intellia Therapeutics aims to transform the lives of people with severe diseases through genome editing treatments. Overall, the biotech industry is facing various challenges and changes, requiring companies to stay adaptable and innovative.
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  • Breaking News in Pharma and Biotech: Gilead's Yeztugo Approval, Biopharma Deal Premiums, BioNTech-CureVac Merger, and AI in Precision Oncology

    Breaking News in Pharma and Biotech: Gilead's Yeztugo Approval, Biopharma Deal Premiums, BioNTech-CureVac Merger, and AI in Precision Oncology
    Jun 20 2025
    Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Gilead has received approval for a twice-yearly HIV drug, Lenacapavir, which will be marketed as Yeztugo, potentially redefining the prep market. In other news, biopharma deal premiums show intense negotiations, with Sanofi paying a high premium for Vigil Neuroscience and Novartis acquiring Regulus for $800 million upfront. BioNTech is merging with CureVac after previously criticizing its failed COVID vaccine program. AI is becoming crucial in precision oncology, with companies like AstraZeneca and Pfizer using computational power to design trials and understand challenging cancers better. Intellia Therapeutics aims to transform lives with genome editing treatments.
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    1 m
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