Recon: EMA approves PRIME designations for two gene therapies; Roche pays $7.1B for Roivant, Telavant’s leading IBD drug

• FDA clears Verve to begin U.S. study of gene-editing treatment for high cholesterol (STAT)
• US FDA Regulatory Affairs Reorg To Include Inspectors Trained In Real-World Evidence, Califf Says (Pink Sheet)
• Drugstore closures are leaving millions without easy access to a pharmacy (The Wall Street Journal)
• Jazz Pharmaceuticals Said to Explore Options Including Sale (Bloomberg)
• Maternal Covid-19 vaccination offers infants immunity for up to 6 months (STAT)
• Health tech investors are getting selective. Expect slow growth, consolidation (STAT)
• UnitedHealth discontinues a controversial brand amid scrutiny of algorithmic care denials (STAT)
• Indivior to pay $385 mln to end final Suboxone monopoly lawsuits (Reuters)

• EMA Says Yes To PRIME Designations For Wet AMD & HAE Gene Therapies (Pink Sheet)
• WHO Calls For Countries To Regulate Use Of AI In Medicine (MedTech Insight)
• Ipsen to refile Alagille drug after EU blocks orphan status (Pharmaphorum)
• AstraZeneca Chief Soriot Slams Reports on His Departure as ‘Fake News’ (Bloomberg)
• Excessive Stockpiling Rule Could Drive Medicines Shortages, Warns Swedish Industry Body (Pink Sheet)
• Canada Tackles AMR With Drug Reserve List; Incentive Recommended To Motivate Antibiotic Development (Pink Sheet)
• Doubts rise over Ottawa’s ability to implement universal drug coverage if pharmacare bill passes (The Globe & Mail)
• Chinese listed firms used endangered animal parts as ingredients - report (Reuters)
• Intuitive’s Q3 sales miss estimates as robot leasing, China demand weigh (MedTech Dive)

• Roche buys Telavant from Roivant for $7 billion, gaining bowel disease drug candidate (STAT) (BioSpace)
• First pill for dengue shows promise in human challenge trial (Reuters)
• Merck discontinues some cancer drug development with China's Sichuan Kelun (Reuters)
• Results on Novartis prostate cancer therapy could expand its use (STAT)
• Data on AstraZeneca cancer drug allay safety concerns but treatment still faces questions (STAT)
• In lung cancer, J&J data amount to latest salvo against AstraZeneca (STAT)
• Anti-obesity drugs can be boost for food makers, investors say (Reuters)
• Scientists infect volunteers with Zika in hunt for vaccines, treatments (Reuters)
• You get an ADC, you get an ADC: Pharmas bite on oncology’s buzziest class (Endpoints)
• Merus touts bispecific antibody efficacy data with a later data cut-off in uncommon NRG1+ cancers: #ESMO23 (Endpoints)
• BioNTech CAR-T manufacturing change leads to fresh data with vaccine combo, with registrational trial plans: #ESMO23 (Endpoints)
• Harpoon, Aligos announce PIPEs; NAYA's all-stock deal; Invea to go public (Endpoints)

• Medtronic gains FDA approval for extravascular defibrillator (MedTech Dive)
• Manufacturers’ Delaying Tactics With Notified Bodies Threaten To Undermine MDR Extensions (MedTech Insight)
• Insulet receives FDA clearance for Omnipod 5 iPhone app (MedTech Dive)
• Done right, AI can give patients crucial information on the quality of their care (STAT)
• Artificial heart maker Carmat implants 7 Aeson devices, shares rise (Reuters)
• From Apple to Lilly: Drugmaker's chief digital officer talks AI experiments and the GLP-1 customer experience (Endpoints)
• Philips’ orders fall in Q3, overshadowing sales growth and return to sleep apnea market (MedTech Dive)
• Anumana names Boston Scientific veteran Maulik Nanavaty as CEO (MedTech Dive)

• FTC Colluded With EU to Veto Illumina-Grail Deal, Lawmaker Says (Bloomberg Law)
• Express Scripts conspired to overcharge pharmacies, class action says (Reuters)
• Fixing America’s health insurance woes is ‘actually very simple,’ says leading economist (STAT)
• Meghan O’Rourke on a medical system not built for chronic illness — and the ‘invisible kingdom’ that could spur change (STAT)
• US trade commission explores impact of patent rules on COVID diagnostics (MedTech Dive)