Recon: Trump Set to Nominate MD Anderson's Hahn as FDA Commissioner; UK Weighs Export Ban on Critical Drugs in No-Deal Brexit Scenario

• Trump set to nominate Stephen Hahn as FDA commissioner, pending vetting process (STAT) (BioCentury)
• Drug companies urge appeals court to remove judge from US opioid litigation (Reuters)
• J&J Reaches $20.4 Million Settlement in Bellwether Opioids Case (NYTimes) (Reuters)
• US government watchdog faults DEA for slow response to opioid crisis (Reuters) (NYTimes)
• New norm? Three biotechs pencil in $100M IPOs (Endpoints)
• Vaping-related illnesses cause 15 US deaths; Virginia, New Jersey latest (Reuters)
• Do big box pharmacies have better generic prices? (Politico)
• They got Pfizer’s ‘Golden Ticket.’ Did it live up to the hype? (STAT)

• Export ban imposed on drugs to prevent no-deal Brexit profiteering (The Times)
• Novartis and Microsoft join forces to develop drugs using AI (Financial Times) (STAT) (Fierce)
• Sanofi to present strategy update in December: CEO (Reuters)
• AstraZeneca strikes global commercial rights deal for Losec for $243m (Pharmafile)
• EU Getting Left Behind On Drug Review Times (Pink Sheet-$)             
• French Industry Attacks Price Cut & Drug Shortage Plans (Pink Sheet-$)
• British drug discovery firm C4X confident of striking deals (Reuters)
• Hearing of Stella Kyriakides, Commissioner-designate for Health (EP)
• 3D Bio-Printed Products: ICMRA Members Discuss Potential Regulatory Frameworks (Focus)

• Vertex taps a team player to take over as CMO during a big transition at the top (Endpoints)
• At Biogen, drug developer Al Sandrock gets a chance to take his shot (STAT)
• User Fee Delinquencies Rising At US FDA After PDUFA Redesign (Pink Sheet-$)
• Biogen's R&D head is out, following string of clinical setbacks (BioPharmaDive) (Fierce)
• Biotech incubator LabCentral to double its space in Boston (STAT)
• Kowa Lands OPDP Untitled Letter Over YouTube Testimonials (Focus)
• Ginkgo forms $150M cell screening pact with Berkeley Lights (Fierce)
• Preparing for CMC Changes is Difficult but Pivotal to Accelerating CGT Development, Experts Are Stressing (IPQ)
• Former Akcea president makes the leap to CEO seat at Avidity Biosciences; Astellas invests $12.5M into two incubators (Endpoints)
• Routine infant rotavirus vaccination tied to fewer hospitalizations (Reuters)
• FDA Warns Chinese Drug Testing Facility for Refusing Inspection (Focus)
• Aiming for label expansion, Merck touts new trial results for antibiotic Recarbrio (Fierce)
• Thermo Fisher pumping $270M into its manufacturing sites (Fierce)
• ElevateBio founds HighPassBio to develop Fred Hutch cell therapy (Fierce)
• Elligo Receives FDA Grant to Study Access of Real-World Data From Electronic Health Records (Press)
• Astellas Commits Nearly $13 Million to Fund Boston-area Start-Up Innovation in Cell and Gene Therapy - Financial support for LabCentral Incubators builds on Astellas’ $1 Billion+ investment in Boston’s Life Science Community (Press)
• Trio Health and Greenleaf Health Partner to Apply FDA-Level Rigor to Groundbreaking Data Platform (Press)
• Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Guidance for Industry (FDA)

• Trovagene Presents Overview of Phase 1b/2 Trial of Onvansertib in Patients with KRAS-Mutated Metastatic Colorectal Cancer (mCRC) at ESMO (Press)
• Immunomic Therapeutics Assumes Sponsorship of ATTAC-II IND for ITI-1000, a Dendritic Cell Vaccine in Phase 2 for the Treatment of GBM (Press)
• Checkmate Pharmaceuticals Announces Dosing of First Patient in a Phase 1b/2 Study in Squamous Cell Carcinoma of the Head and Neck with Lead Investigational Candidate CMP-001 (Press)
• Bay Labs achieves significant clinical milestone and receives breakthrough device designation; Changes name to Caption Health (Press)

• NIH puts up $20m for new medtech hubs (MassDevice) (NIH)
• FDA to Further Investigate Implantable Devices Containing Certain Metals (Focus)
• NIH researchers develop MRI with lower magnetic field for cardiac and lung imaging (NIH)
• FDA Warns of Widespread Device Cyber Vulnerabilities (Focus)
• Could the U.S.-China trade war stifle medical device innovation? (MassDevice)
• Fired engineer claims BD sparked CareFusion recalls before acquisition (MassDevice)
• Philips touts Stellarex balloon study (MassDevice)

• Trade agreement drug monopoly is obsolete given faster, better drug discovery (STAT)
• Cannabis Industry Lobby Says FDA Should Regulate Legal Pot (Law360-$)
• The Deep Divide: State Borders Create Medicaid Haves And Have-Nots (KHN)
• Why Verma is now celebrating Obama-era ACOs (Politico)
• Most Supplement Users Back Enhanced FDA Oversight of These Products (Pew)

• FDA Advisory Committee Calendar

• UK Pilots 'Revolutionary And Needed' Antibiotic Payment System (Scrip-$)
• European Product Revenues Threatened By IP Policy Amendment (BioCentury)
• Good clinical practice for clinical trials (MHRA)

• Big Pharma CEOs' Chinese names: Here's how they look and what they mean (Fierce)
• Asia Regulatory Roundup: Australia Suspends Sales of Eight Breast Implants After Safety Review (Focus)

• Government not to lift price caps on medical devices, open to rationalising margins (Economic Times)
• India looks to set rare diseases drug policy and develop domestic treatments (PharmaLetter-$)

• High ambitions: Uruguay cannabis firm targets booming global market for medical marijuana (Reuters)

• Screening vs. Diagnostics: Can Preventive Genomics Clinics Help Healthy Patients? (Harvard Bill of Health)