Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world. Sarepta Therapeutics has released data on its new drug for Duchenne muscular dystrophy, showing potent boosting of dystrophin protein production. However, some side effects, including electrolyte imbalances, were also highlighted. Astrazeneca and Daiichi are seeking FDA approval for their drug Enhertu as a "tumor agnostic" treatment, and the FDA is currently reviewing their application. Bristol Myers has received positive data from a trial of a subcutaneous formulation of Opdivo in kidney cancer, showing similar efficacy to the intravenous formulation. Biotech IPOs continue to be an important source of funding for the industry, with Alto Neuroscience and Fractyl Health preparing for initial stock offerings. Merck Manuals is focusing on a "one health" approach, integrating human, animal, and environmental health in medical education and practice.Philips has announced that it will stop selling sleep and respiratory devices in the US due to a consent decree from the FDA. This decision comes as Philips faces regulatory scrutiny and potential legal action related to quality issues with its sleep apnea devices. Medical device companies Stryker, Boston Scientific, and BD are set to post their earnings this week. Absolutions has received FDA breakthrough designation for its abdominal wall closure device, aiming to reduce the risk of hernia by distributing suture tension over a large area of tissue. Globus has laid off employees from NuVasive following their merger. Masimo has forced Apple to redesign its smartwatches in a long-running patent dispute.The pharmaceutical industry is in a race to develop groundbreaking drugs for pain relief. Tanezumab, developed by Eli Lilly and Pfizer, was dropped due to safety concerns. Attention has turned to Vertex Pharmaceuticals' candidate vx-548, which has shown positive results in phase 2 trials for chronic nerve pain. South Rampart Pharma has won fast track designation for its novel drug that activates pain signaling pathways without causing liver and kidney toxicities. Tonix Pharmaceuticals is repurposing an existing technology for the treatment of fibromyalgia, with positive late-stage results. These developments offer hope for patients suffering from chronic pain conditions and could generate significant revenue for the companies involved.Overall, these developments highlight ongoing challenges and changes in the medtech industry, including regulatory scrutiny, mergers, and patent disputes. Medtech companies must navigate these complexities while leveraging connected ecosystems, data, and strategic planning to drive innovation in healthcare.Thank you for tuning in to Pharma and Biotech daily. Stay informed, stay ahead.

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