Recon: AstraZeneca’s flu vaccine to get FDA review; EU medtech industry “speechless” over plan to delay Eudamed database

• US FDA accepts AstraZeneca's self-administered flu vaccine for review (Reuters)
• Verve Gets FDA Go-Ahead for First In-Human Base Editing Study in US (BioSpace)
• FDA Approves BioMarin’s Voxzogo for Young Children with Dwarfism (BioSpace)
• CDC recommends rationing of RSV shot due to shortages (STAT)
• Roche settles US patent lawsuit against Biogen over blockbuster arthritis drug (Reuters)

• EU Asks for Details on Anesthesia Risks for Weight-Loss Drugs (Bloomberg)
• EU sets up new mechanisms to stave off medicine shortages (Reuters)
• Pharmaceutical industry close to deal with UK on drug pricing, says Novartis (Financial Times)
• ‘Missed opportunities’: Why a U.K. government plan to disclose financial ties between pharma and docs may fall short (STAT)
• Commission fines pharma companies €13,4 million in antitrust cartel settlement (European Commission)
• Insulin is increasingly affordable in the U.S. What about the rest of the world? (STAT)
• Suspected fake Ozempic puts several in hospital in Austria (Reuters)
• Belgium plans temporary ban on use of Ozempic for weight loss (Reuters)

• Why AstraZeneca’s CEO is accusing British tabloids of ‘fake news’ (STAT)
• Roivant’s CEO is a star, but even a blockbuster deal can’t escape biotech’s black hole (STAT)
• With an old approach but new energy, ADCs take center stage as promising cancer treatments (STAT)
• Startup launches with $245 million for twice yearly asthma treatment (STAT)
• OrbiMed raises $4.3B across three funds to invest in biotech companies, as well as royalty deals and China startups (Endpoints)
• Heard at #ESMO23: Novartis and BeiGene fallout; Now I know my ADCs; and a standing ovation (Endpoints)
• Bristol Myers pays $350M upfront for rights to heart drug Camzyos in Asia (Endpoints)
• BrainStorm to lay off workers; Lilly inks a subcutaneous deal (Endpoints)
• Immutep touts mid-stage data for LAG-3 drug in first-line NSCLC, finalizing plans for PhIII test: #ESMO23 (Endpoints)
• Updated: Novartis 'on track' to complete restructuring post Sandoz spin, pushes back Pluvicto filing (Endpoints)
• Idorsia lays off up to 300 people, plans for pipeline prioritization in effort to extend cash runway (Endpoints)
• Rampart Bioscience raises $125M for non-viral gene therapies (Endpoints)
• Aiolos Bio launches with $245M Series A, chasing one of asthma’s hottest targets (Endpoints)
• Danaher Q3 revenue declines as demand challenges continue (MedTech Dive)

• EU Medtech Sector "Stunned" And "Speechless" At Further Proposals For Delays To Eudamed Database (MedTech Insight)
• UK Regulator Assesses International Recognition Options As It Pursues ‘Joined-Up’ System
• (MedTech Insight)
• For Parkinson’s disease, advances spurred by Apple Watch offer a glimmer of hope (STAT)
• A hacker leaked millions of 23andMe users' data, potentially putting sensitive health information in jeopardy (Endpoints)
• J&J MedTech Chairman Ashley McEvoy to step down (MedTech Dive)
• Icahn sues to remove Illumina board members, asks for at least $476M in damages (MedTech Dive)
• Intuitive Surgical Stock Remains Suppressed, Despite Procedure Growth (MedTech Insight)

• Planned Parenthood must face trial over Texas Medicaid fraud claims (Reuters)
• From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information (FDA Law Blog)