Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Genmab has acquired Merus, a rising star in the field of oncology, for $8 billion. The acquisition includes Merus' bispecific antibody, petosemtamab, which targets EGFR and LGR5 and has shown potential for head-and-neck cancer. In other news, GSK CEO Emma Walmsley is stepping down after nine years, with Chief Commercial Officer Luke Miels set to replace her next year. The FDA's decision to disclose complete response letters in real-time has raised questions about transparency and the agency's role. Additionally, Biogen has shuffled staff after ending work on AAV, while Heidelberg has cut 75% of its staff after missed royalty payments.The FDA's real-time disclosure of complete response letters benefits investors by providing greater visibility into regulatory decisions. In September, the FDA's actions included boosting Keytruda while rejecting two spinal muscular atrophy therapies due to manufacturing issues. A judge's ruling on the FDA's authority over laboratory-developed tests reflects the impact of a recent Supreme Court decision. Six FDA decisions to watch for in Q4 could have significant implications for the biopharma industry and patients. Recent developments include positive results for an immuneering asset in pancreatic cancer, FDA approval for Lilly's oral SERD for breast cancer, and positive outcomes for uniQure's Huntington's therapy. Additionally, the FDA is streamlining development of cell, gene, and regenerative therapies. Other news includes the revival of a dormant drug as a potential autism treatment, setbacks in obesity studies, and unexpected rejections for certain therapies. Upcoming webinars and job opportunities are also highlighted.Listeners are encouraged to provide feedback on topics they would like to see covered in future episodes.

Support the show