Good morning from Pharma and Biotech daily, the podcast that gives you only what's important to hear in the Pharma and Biotech world. In today's episode, we have some exciting news from the world of gene therapy and cell therapy. Beacon Therapeutics, a start-up built from biotech parts, has launched with $120m to develop gene therapies for ocular diseases. The company will be led by former executives of other ocular gene therapy developers, including Nightstar, Gyroscope and AGTC. In other gene therapy news, the FDA has set decision dates for Vertex and CRISPR Therapeutics' gene editing drug. The regulator will issue separate verdicts on the pioneering treatment's use in sickle cell disease and beta thalassemia, with the first expected late this year. Meanwhile, a cell therapy start-up is looking to an IPO to avert financial peril. Turnstone Biologics, a former partner of Takeda and AbbVie, is seeking an IPO while acknowledging there is "substantial doubt" it can survive. And Ferring has taken a step towards its first gene therapy sales with the FDA clearing its planned scale-up process for its bladder cancer treatment Adstiladrin.Moving on to patient engagement in research studies, pharmaceutical companies need to reassess their approach if they want to improve long-term participant engagement. A webinar by StudioID explored findings from direct-to-patient, real-world research programmes and provided actionable takeaways for long-term registries and studies.The rise in searches for elective surgeries on Google indicates an increase in the market for elective procedures, signaling better times for medtech companies. The robotic surgery market is showing no signs of slowing down, favoring Intuitive Surgical's da Vinci, according to J.P. Morgan. And researchers have developed a bioprinter that can print multiple materials, allowing them to print cells, drug-releasing meshes, and sensors targeting wound repair and custom prosthetics.The American Medical Association (AMA) has approved recommendations aimed at preventing overdoses, reducing gun violence, and reducing physician reliance on body mass index. The AMA also called for the establishment of guardrails for AI and Medicare payment reform at its annual meeting. Meanwhile, a report from the CMS Actuaries predicts that US health spending will surpass $7 trillion by 2031 due to the unwinding of COVID-19 public health emergencies and recent legislation.Pharmaceutical companies are preparing for potential changes to the drug pricing provisions of the IRA, with lobbying group PhRMA laying the groundwork for future changes. And Verve has partnered with Lilly on a gene editing therapy for heart disease, with Lilly paying the company $60m upfront.In other news, the US Food and Drug Administration (FDA) has put Mersana's investigational antibody-drug conjugate on partial clinical hold in two ovarian cancer trials after five patients experienced serious bleeding, which resulted in their death. The drug is designed to target NaPi2b, a protein that is overexpressed in ovarian cancers.Lastly, Medicare has named 43 Part B drugs that will face price hike penalties due to rising prices above inflation, resulting in lower coinsurance rates next quarter. Pfizer has refiled its Seagen deal paperwork with regulators, extending the time period for the Federal Trade Commission to request more information on the $43 billion acquisition through mid-July. The FDA has set decision dates for Vertex and CRISPR gene editing drug, with separate verdicts expected late this year for its use in sickle cell disease and beta thalassemia. And as Illumina’s CEO Francis deSouza departs, anti-trust regulators have ordered the company to divest its liquid biopsy unit, leading to speculation about the future of Grail. That's all for today's episode. Thank you for tuning in to Pharma and Biotech daily, and we'll see you next time with more exciting updates from the world of Pharma and Biotech.

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Erscheinungs­datum: 16.6.2023, 07:00:00