More potent version of Global Blood sickle-cell drug improves hemoglobin response in small study (STAT)
ASH: Servier unveils full dataset for Tibsovo in specific AML mutations, and the FDA appears a stone's throw away (Endpoints)
ASH: Another 'off-the-shelf' cell therapy leader shows durability issues, raising renewed concerns about emerging field (Endpoints)
ASH: Gilead's Kite unveils more data on Yescarta's win in second-line lymphoma patients, setting up battle for SOC (Endpoints)
ASH: A cell therapy startup with roots in Irv Weissman's lab nearly wipes out a chronic side effect in early trials (Endpoints)
ASH: Tessa Therapeutics' next-gen cell therapy clears four patients' tumors in early study (Endpoints)
Eli Lilly's Van Naarden hands $380M cash to Flagship-backed upstart in major new oncology deal (Endpoints)
Qiming-backed CANbridge gets its Hong Kong IPO as Nasdaq slowdown prompts renewed market analysis (Endpoints)
Junshi and Coherus plan to hustle the latest PD-1 to the FDA after an upbeat PhIII assessment (Endpoints)
As year-end deals start to sizzle, CSL moves a biotech buyout to the front burner with deal expected Tuesday — report (Endpoints)
Medtech
Medtronic's Covidien faces another Class I recall of beleaguered Puritan Bennett ventilators (Fierce)
Abbott elects CEO Ford chairman of the board as predecessor White retires after 40 years (Fierce)
Neurostimulator to treat stroke fails to gain FDA advisory panel support (MedtechDive)
Government, Regulatory & Legal
U.S. Supreme Court snubs J&J's bid to avoid Mississippi talc lawsuit (Reuters)
Bayer says encouraged by U.S. Supreme Court decision (Reuters)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
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Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.