Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.A new data release shows that Summit's Keytruda competitor, Ivonescimab, had better overall survival rates in Asian patients compared to those in North America and Europe. Despite this, the drug narrowly missed the statistical significance threshold required by the FDA for approval in Western countries. Meanwhile, Rapport Therapeutics saw a 180% increase in its stock value after positive mid-stage data for its epilepsy pill, and the FDA opted for a consumer "green list" instead of addressing compounded versions of obesity drugs. The FDA's leadership turnover has led to confusion and uncertainty for small and medium biopharma companies. Lilly is seeking individuals who are willing to challenge the status quo in medicine.FDA expert panels are being criticized for lack of balance, with some meetings being one-sided. RFK Jr. faced bipartisan criticism for his anti-vaccine views during a Senate hearing. Meanwhile, Servier committed up to $530 million in an eye cancer deal and Gilead partnered with the US State Department to distribute a drug to low-income countries. The FDA released a new rare disease approval framework and dropped heavily redacted rejection letters. Amidst uncertainty in FDA leadership, small and medium biopharma companies are left without clear guidance for their therapies. Opinion pieces highlight the potential of small molecules in gene therapy for Duchenne muscular dystrophy and criticize the lack of balance in FDA expert panels. The newsletter also includes upcoming events, job listings, and a request for feedback on coverage topics.

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