Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Astrazeneca acquired a biotech startup called Amolyt for $800 million, adding a late-stage drug prospect for parathyroidism to its rare disease portfolio. Bio, a lobbying group for the biopharmaceutical industry, changed its stance and now supports a bill to limit China's role in US biotech. German biotech Tubulis secured €128 million in financing to capitalize on the momentum in antibody-drug conjugates (ADCs). J&J and Novo are supporting Asgard's efforts to develop personalized cancer therapies that reprogram tumor cells in the body. The FDA is focusing on early deaths in a meeting regarding broader CAR-T use in myeloma, particularly in trials from Bristol Myers Squibb and Johnson & Johnson. Additionally, there are five questions facing emerging biotech companies as they navigate through the industry's current landscape. The newsletter also covers various topics including the use of AI-enabled digital twins to secure the pharmaceutical supply chain, Medicare coverage of weight-loss drugs, and shifts in the clinical trial landscape.The EPA has issued a final rule limiting ethylene oxide emissions from medical device sterilizers, giving companies two years to comply. Exactech received a warning letter from the FDA regarding faulty implant packaging analysis. US hospitals expect an increase in procedures as staffing pressures ease, potentially benefiting companies like Boston Scientific, Medtronic, and Stryker. The FDA is seeking feedback on expanding premarket cybersecurity guidance. Additionally, AI and digital health trends are becoming more prominent in the medical device industry.AstraZeneca has acquired Amolyt Pharma for $1.05 billion, adding to its rare disease portfolio with late-stage candidate eneboparatide for hypoparathyroidism. The deal also includes ownership of azp-3813, being assessed for acromegaly in a phase I trial. In other news, Vertex failed to convince the UK watchdog of the value of its CRISPR therapy Casgevy, and Wuxi AppTec has been removed from a trade group amid US national security concerns. ADC Biotech Tubulis closed a $138 million financing round to support its lead solid tumor antibody-drug conjugate candidates.The Biden administration has proposed the implementation of "march-in rights" to seize patents for drugs that are priced unreasonably high. This move has sparked debate among stakeholders, with concerns about the potential negative impact on innovation in drug development. Despite efforts to bring down drug prices, critics believe that federal intervention in patent protection could have devastating consequences.The biosimilars market in the U.S. has been limited by patent thickets and insurance contracting, but there are signs of momentum. CVS has launched a new venture in biosimilar drug experimentation, while biosimilar makers are using different strategies to compete with top-selling drugs like Humira. Sandoz has spun out of Novartis to become a standalone generic drugmaker.Thank you for listening to Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.

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