Pharma and BioTech Daily

• Navigating Uncertainty: Updates from the Pharma and Biotech World

  Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Roche has made a significant move in the pharmaceutical industry by acquiring 89bio for $3.5 billion, with a contingent value right of $6 per share. The acquisition includes pegozafermin, an analog in late-stage development for metabolic dysfunction-associated steatohepatitis. Meanwhile, former CDC director Susan Monarez spoke to the Senate about her firing, alleging that Health Secretary Robert F. Kennedy Jr. accused CDC employees of "killing children." In other news, Roivant and Pfizer's therapy shows promise in a rare inflammatory condition, BMS and Novo Nordisk have announced layoffs in New Jersey, and Sino Biological has developed a high-throughput platform for AI-driven antibody discovery. Additionally, Lexicon has backed phase III decision for a non-opioid pain medication, and Rosnilimab shows promise as a potential next-generation treatment for rheumatoid arthritis. The pharmaceutical industry is navigating uncertainty during turbulent times, with companies like Arsenal and X4 laying off staff to cut costs.The FDA is cracking down on pharmaceutical advertisements in a new regulatory initiative, targeting loopholes in direct-to-consumer ads. Experts believe the FDA is focusing on the wrong issues and should instead address the lack of regulations for compounder drug ads. Akeso, a biotech company in China, has seen success under CEO Michelle Xia's leadership. Other news in the pharmaceutical industry includes the rise of predictive care powered by consumers and AI, ongoing prescriptions of Sarepta's DMD gene therapy despite safety concerns, and companies like Sanofi pulling back from the UK market. Pharma companies are facing challenges in navigating uncertain times amidst layoffs and regulatory crackdowns. Stay tuned for more updates on the latest developments in the industry.

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• Pharma and Biotech Daily: Navigating the Ever-Evolving Landscape

  Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Eli Lilly's oral weight loss pill, orfoglipron, has faced challenges in meeting expectations, possibly due to an over-representation of males and Hispanic patients in the phase III study. The company is now presenting detailed late-stage data to paint a competitive profile for the drug. Meanwhile, the FDA has targeted Lilly and Novo Nordisk for downplaying risks of their GLP-1 weight loss drugs in advertising, particularly during a prime time special with Oprah Winfrey. Lilly is also investing in a $5 billion manufacturing plant in Virginia, part of a larger $27 billion U.S. investment plan.In other news, GSK is committing $30 billion to boost R&D and manufacturing operations in the U.S., showing a strong commitment to innovation. Additionally, advancements in AI-driven antibody discovery technology by Sino Biological are revolutionizing the field of biotechnology. The pharmaceutical industry is facing tightening oversight and regulatory changes, as well as exploring predictive care powered by consumers and AI technology.This dynamic landscape highlights the importance of staying informed and adaptable in the ever-evolving world of Pharma and Biotech.

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• Pharma and Biotech Daily: Novo's Breakthrough Drug, Sarepta's DMD Therapy, and Industry Trends

  Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Novo's amylin analog drug, cagrilintide, has shown a significant 11.8% weight loss in a phase III trial, with improved safety data to address past tolerability issues. The FDA is set to make a decision on the drug, with significant stakes for the company and the Barth Syndrome community. Additionally, Sarepta's DMD gene therapy is still being prescribed by doctors despite safety concerns, and new members have been appointed to the ACIP panel. Stealth Biotherapeutics is awaiting a verdict on their potential treatment for Barth Syndrome, while Sino Biological's high-throughput platform for AI-driven antibody discovery offers promise for advancing therapeutic candidates. Novo and Lilly are competing for market leadership in obesity treatment, while Sanofi and other pharma companies are pulling back from investments in the UK. The pharmaceutical industry is navigating uncertainty during turbulent times.

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• Pharma and Biotech Daily: Novartis' $5.7 Billion Deal and Myasthenia Gravis Market Flourishing

  Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Novartis and Monte Rosa have entered into their second molecular glue deal worth up to $5.7 billion, with Novartis putting $120 million upfront for more of the biotech's AI-discovered degraders. The myasthenia gravis market, once sparse, is now flourishing with new treatments approved and promising late-stage trial results from companies like Argenx and Regeneron. In other news, AstraZeneca has suspended its $270 million commitment in the UK, the FDA has flip-flopped on scrapping advisory committee meetings, and Sino Biological has developed a high-throughput platform for AI-driven antibody discovery. The myasthenia gravis space is heating up with targeted therapies, with several companies releasing promising late-stage trial results. Biogen is developing a pipeline for lupus, with investors showing interest in their programs. The FDA has several actions scheduled for September, including Merck's proposed subcutaneous formulation of Keytruda. Eli Lilly's obesity pill, Orforglipron, is in focus at the European Association for the Study of Diabetes meeting. In the cancer news, Merck's Keytruda challenger faces consistency problems, while other companies like Daiichi Sankyo and Biontech report positive data. Capsida reports a patient death in a gene therapy trial, while Alkermes shows promise in narcolepsy treatment. FDA is looking to streamline the development of non-opioid painkillers. Various webinars and events are upcoming in the pharma industry. Job opportunities are available at companies like Moderna, Abbvie, and Regeneron. Overall, the biopharma industry is seeing advancements and progress in various therapeutic areas.

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• Pharma and Biotech Daily: Trump Considers Tariff Exemptions and More

  Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.President Trump is considering exempting certain "non-patented" pharmaceuticals from tariffs, although specific guidelines have not yet been released. The Intercept has withdrawn a liver drug from the US market, and Ocaliva, approved for primary biliary cholangitis in 2016, did not receive full approval last year. Merck is cutting 125 employees in the UK as it ends R&D work. AbbVie has extended exclusivity for its drug Rinvoq until 2037 with a generics settlement. Novo's headcount has increased by 81% in five years as revenue climbed. The FDA is reportedly preparing an order restricting Chinese drug licensing deals. Capsida has reported a patient death in a gene therapy trial. Novartis' BD team is busy with bolt-on deal promises for 2025. That's all for today's news in the Pharma and Biotech world. Thank you for listening!

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