OnKure Therapeutics’ Post

The Breakthrough Therapy Designation, which will expedite the development and regulatory review of TAR-200 in this setting, is based on findings from the phase 2b SUNRISE-1 trial. https://lnkd.in/gNfsQyq2

Lung Imaging Breakthrough: FDA Clears Brainomix 360 e-Lung System for AI-Driven Respiratory Care The FDA has granted clearance to Brainomix's 360 e-Lung system, an AI-powered software designed to detect idiopathic pulmonary fibrosis (IPF) and other interstitial lung diseases (ILDs) by analyzing CT scans. This clearance follows successful phase II clinical trial results, published in the American Journal of Respiratory and Critical Care Medicine, which demonstrated the system's superior performance in identifying high-risk IPF patients. Conducted in collaboration with AstraZeneca, the trial validated the system's accuracy in quantifying pulmonary fibrosis using proprietary imaging biomarkers. The Brainomix 360 e-Lung system promises to revolutionize lung disease diagnosis and management, offering a non-invasive, efficient alternative to traditional methods and setting a new standard in respiratory care. For more details please click the link! https://lnkd.in/dsgjEcuD #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

The evolution continues...one of, if not the first report, of a phase I clinical trial with a bispecific ADC (HER3-EGFR directed) https://lnkd.in/e_DquMPZ

oday. MAIA announced that an abstract about its Phase 2 THIO-101 clinical trial named “A phase 2, multicenter, open-label, dose-optimization study evaluating telomere-targeting agent THIO sequenced with cemiplimab in patients with advanced #NSCLC: Updated results” was accepted for poster presentation at the #ASCO24 Annual Meeting taking place May 31-June 4, 2024, in Chicago, Illinois. The poster is scheduled for presentation on June 3, 2024, from 1:30pm to 4:30pm CST. More information can be found in the press release here: https://bit.ly/4dL9ngY #NSCLC

Many people are not in the weeds, but we are in a fight right now for access to oncology care and drug reform. The hearings from 2 days ago. We have a crisis right now. Drugs like Cisplatin and 5FU have been used for years and are now a ghost for many. The Moonshot initiative sounds good, but there has to be an understanding of the dominating and underlying problems: PBMs, the IRA, lack of vendor accountability, Payer coverage, 340B, Prior authorization ect. There is NO MOONSHOT without acknowledging this first. Great Job by Ted Okon and others communicating the message. ---------------------------- https://lnkd.in/gUghkC6z ---------------------------- Minute 30:00 Minute 1:24:50 Minute 1:55:00 Minute 1:56:20 Minute 1:58:19 Minute 2:07:30 ------------------------ Merck Cardinal Health Daiichi Sankyo, Inc. Ron Harrison Novartis Community Oncology Alliance Texas Oncology McKesson Kathy Oubre, MS Florida Cancer Specialists & Research Institute American Oncology Network, LLC OneOncology GSK Amgen CVS Pharmacy Optum Humana Mark Cuban Cost Plus Drug Company, PBC Cigna Healthcare Moderna Eli Lilly and Company Bristol Myers Squibb Oncospark OncoHealth Johnson & Johnson Pfizer

We are thrilled to announce that JEITO has led a €75M Series B financing round for NMD Pharma A/S, a Danish clinical-stage biotech company dedicated to developing innovative treatments for patients living with severe neuromuscular disorders. Following our initial investment in 2022, this second round of funding illustrates our steady support to growing and perfoming NMD Pharma A/S and its ambition to become a leading, global, clinical-stage company. The proceeds will be used to complete three Phase 2 clinical Proof of Concept studies with NMD670, the company's leading CIC-1 inhibitor, which has the potential to restore muscle function in a range of rare neuromuscular diseases, including myasthenia gravis, spinal muscular atrophy, and Charcot Marie Tooth. The funding will also contribute to grow its pipeline and support the expansion of NMD Pharma’s clinical and commercial operations in Denmark and in the US. We are very proud to stand alongside Thomas Holm Pedersen, the CEO, and his team as they embark on this new chapter, driven by their unwavering commitment to making a positive impact on patients. Read more 👉 https://lnkd.in/ev_3hjv8 #FasterForThePatient #privateequity #lifesciences #biopharma #healthcare #neuromusculardisease

LucidQuest Strategic Insights (lqventures.com) >>> Gene&Cell Therapy >> EyePoint poaches medical chief from Apellis; Sandoz CFO, longtime BioNTech exec to retire: Ramiro Ribeiro After six years as head of clinical development at Apellis Pharmaceuticals, Ramiro Ribeiro is joining EyePoint Pharmaceuticals as CMO. “The retinal community is relatively small, so everybody knows each other,” Ribeiro told Endpoints News in an interview. “As soon as I started to talk about EyePoint, I got really good feedback from KOLs and physicians on its scientific standards and quality of work.” Ribeiro kicked off his career as a clinician in Brazil, earning a doctorate in stem cell therapy for retinal diseases. He previously held roles at Alcon and Ophthotech Corporation, now known as Astellas’ M&A prize Iveric Bio. At Apellis, Ribeiro oversaw the Phase III development, filing and approval of Syfovre, the first drug for geographic atrophy secondary to age-related macular degeneration (AMD). The complement C3 inhibitor went on to make $275 million in 2023 despite reports of a rare side effect that only emerged after commercialization. Now, Ribeiro is hoping to replicate that success with EyePoint’s lead candidate, EYP-1901 for wet AMD, which is set to enter the Phase III LUGANO trial in the second half of the year after passing a Phase II test in December. Ribeiro told Endpoints he was optimistic about the company’s intraocular sustained-delivery tech, which he said could help address treatment burden and compliance issues seen with injectables. He also has plans to expand the EyePoint team. “My goal is not just execution of the Phase III study — of course that’s a priority — but also looking at the pipeline and which different assets we can bring in to leverage the strength of the team that we have,” Ribeiro said. — Ayisha Sharma Remco Steenbergen → Sandoz CFO Colin Bond will retire on June 30 and board member Remco Steenbergen will replace him. Steenbergen, who will step down from the board when he takes over on July 1, had a 20-year career with Philips and has held the group CFO post at Deutsche Lufthansa since January 2021. Bond joined Sandoz nearly two years ago and is the former finance chief at Evotec and Vifor Pharma. Investors didn’t react warmly to Wednesday’s news as shares fell by almost 4%. The Swiss generics and biosimilars company, which finally split from Novartis in October 2023, has also nominated FogPharma CEO Mathai Mammen to the board of directors. The ex-R&D chief at J&J will be joined by two other new faces, Swisscom chairman Michael Rechsteiner and former Unilever CFO Graeme Pitkethly. On Monday, Sandoz said it completed its $70 million purchase of Coherus BioSciences’ Lucentis biosimilar Cimerli sooner than expected. The FDA then approved its first two biosimilars of Amgen’s denosumab the next day,… #lucidquest #genetherapy #celltherapy

It's an exciting time for Novo Nordisk 🤩, as they've just announced they are partnering with Flagship Pioneering's Valo Health to develop a new AI-driven drug for cardiovascular diseases 💙. This collaboration brings together the expertise of two leading healthcare companies, with Novo Nordisk's 100 years of experience in diabetes and cardiovascular diseases, and Valo Health's innovative AI-driven approach to drug design and development. The new drug is expected to be the first of its kind, using artificial intelligence and machine learning to identify, design, and develop cardiovascular drugs. By using this AI-driven approach, Novo Nordisk and Valo Health are hoping to create the most effective drug possible, with the goal of having it to market as quickly as possible. 💪 We are looking forward to seeing the results of this collaboration, and how it will shape the future of cardiovascular research and development. 🔮 #NovoNordisk #ValoHealth #AIDrugs

While the big news out of Boston Scientific Q4 earnings was obviously the approval of Farapulse*, the company also announced a (hopefully slight) delay to the approval of its ACURATE neo2 TAVR based on interim readout of their ongoing ACURATE IDE study. As an ongoing trial the company is unable to comment on details, but CEO Mike Mahoney noted that the company expects a readout of full results in the second half of 2024. The trial is designed with 1500 patients in the main randomized cohort, with a 1:1 split to a control group of currently available TAVR valves (Edwards' SAPIEN 3 and Medtronics CoreValve). Primary endpoints are a 1-year look at clinical outcomes (all-cause mortality, all stroke, and rehospitalization). ACURATE neo2 has apparently done great in Europe (where it has had CE mark since 2020), with the company noting it sold 70,000 valves last year. Trial results (including post-market follow ups) from Europe have been strong.

“Planning for Co-Development of CDx”- I attended this SBIA presentation two years ago and it stands as true now as then, maybe more so, particularly with the OCE Oncology Drug Products Used with Certain In Vitro Diagnostics Pilot Program: “Under current policy, in certain scenarios the FDA may decide to approve a treatment that requires use of a companion diagnostic even if a corresponding companion diagnostic does not receive marketing authorization when the treatment is approved. In these cases, tests offered as laboratory developed tests (LDTs) are being used for patient treatment decisions. FDA has generally exercised enforcement discretion for LDTs, meaning that, at this time, FDA generally has not enforced applicable requirements for these devices. FDA intends to pilot a new approach to provide greater transparency regarding performance characteristics that certain tests for oncology biomarkers used for selection of oncology drug products should meet. Through this transparency FDA also seeks to support better and more consistent performance of LDTs, resulting in better drug selection and improved care for patients with cancer.”