Pharma and BioTech Daily

Pharma and Biotech Daily: The Latest in Industry Partnerships, Drug Developments, and Regulatory Updates


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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. GSK has entered a partnership with Hengrui worth up to $12 billion, focusing on the COPD candidate HRS-9821. The FDA's new voucher policy has caused confusion among experts, as it lacks clear definition and was announced without public input. The American Medical Association urges RFK Jr. to maintain the preventive task force, and Sarepta denies a patient death is linked to Elevidys as the FDA launches a probe. Biopharma companies are leaning towards holistic treatments for Alzheimer's, while Atai-partnered schizophrenia drug fails in a mid-stage trial. Boehringer partners with Irish startup Re-Vana in a $1 billion+ eye deal.As the Alzheimer's space becomes more competitive, biopharma companies are focusing on holistic treatments beyond disease-modifying drugs like Leqembi and Kisunla. Companies such as Bristol Myers Squibb, Acadia, Otsuka, and Lundbeck are renewing their search for symptomatic treatments. Five upcoming data drops could potentially lead to more effective therapies for Alzheimer's. Sarepta Therapeutics is facing challenges due to safety concerns surrounding its gene therapies, leading to a drop in stock value. The FDA's new voucher program aims to offer accelerated pathways for drugs meeting certain criteria, but experts criticize the lack of transparency and public input in the policy's announcement. Sarepta's future is uncertain as the FDA considers a new study for Elevidys, and the EU issues a negative opinion on the drug. Other news includes delays in the FDA decision on GSK's Blenrep, AstraZeneca's PIII win with nanobody treatment for myasthenia gravis, and the removal of thimerosal from influenza vaccines. George Tidmarsh has been appointed as the new chief of FDA's CDER.
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