Recon: NICE Recommends Lilly's Verzenios for Advanced Breast Cancer; J&J to Use Apple Watch for Heart Study

• Key House Dem: I don't want to 'punish' drug companies (The Hill)
• Rep. DeGette, newly atop an oversight subcommittee, promises to grill drug industry CEOs and investigate insulin makers (STAT)
• HHS secretary, Senate Finance Republicans talk drug pricing (The Hill)
• PhRMA CEO 'hopeful' Trump officials will back down on drug pricing move (The Hill)
• Johnson & Johnson to Use Apple Watch App for Heart-Health Study (WSJ) (Press)
• Apple is in talks with private Medicare plans about bringing its watch to at-risk seniors (CNBC) (Forbes)
• Eli Lilly arranged for surprise purchase of Loxo, as the biotech pressed potential of its experimental drug (STAT) (Endpoints)
• US shutdown taking toll on FDA, USDA inspection roles: experts (Reuters)
• As the US shutdown rolls on, blockbuster launches line up for 2019 (Evaluate)
• Gilead, Genentech Join PhRMA (LinkedIn)
• A ‘digital pill’ for cancer patients is rolled out for the first time, in hopes of improving outcomes (STAT)
• The US should assess the economic value of drugs rather than leave it up to other countries (STAT)
• Amgen's postmenopausal osteoporosis drug wins FDA panel backing (Reuters) (Endpoints) (Press)
• DNA test company 23andMe now fueling medical research (NBC)
• Novartis and Adamis' EpiPen challenger launches at double-digit discount (Fierce)
• Health committees finalized in new Congress (Politico)

• AP Exclusive: UN health chief orders probe into misconduct (AP) (The Hill)
• Eli Lilly's Verzenios scores NICE recommendation for advanced breast cancer (Pharmafile) (Fierce)
• Israeli authorities to demand $271M bill from tax-advantaged Teva: report (Fierce) (Calcalist)
• Pfizer partners with Medochemie to make drugs in Vietnam (Fierce)
• Pharma comments on Brexit withdrawal rejection (PharmaTimes)
• GSK extends expiration date for Tesaro offer (PharmaTimes)
• J&J’s Erleada cleared for early prostate cancer in Europe (PMLive)
• Novartis R&D Chief Tsai On 2019 Goals, Priorities, BD And Digital Advances (Scrip-$)
• Japan Approvals Include World Firsts For Romosozumab, Spinal Injury Cell Therapy (Pink Sheet-$)

• After the Storm — A Responsible Path for Genome Editing (NEJM)
• Bayer to close its Robinson site, impact 600 employees (Pittsburgh Post-Gazette) (Pharmaceutical Manufacturing)
• Gilead’s clinical research VP moves to U.S.-China NASH startup Terns Pharma (Fierce)
• Diversity in clinical trials defines good science and better medicine (STAT)
• The market for migraine drugs (Nature)
• Merck Manuals Addresses Common Misconceptions Around Migraines (Press)
• Alzheon hits another dead end funding its Alzheimer’s program, pulls second IPO attempt (Endpoints) (Fierce)
• Macular degeneration trial will be first human test of Nobel-winning stem cell technique (STAT) (Endpoints)
• Short seller Citron draws fresh blood going after another biotech scalp — but can it still cut that deep? (Endpoints)
• Is the Drug Industry an Existential Threat to the Private Health Insurance Business? (Health Care Policy and Marketplace Review)
• Reckitt CEO plots exit amid consumer health split, and investors aren't happy (Fierce)

• Actelion Receives Complete Response Letter from FDA for Opsumit sNDA (Press)
• Aptinyx fails phase 2 pain test, sparking stock crash (Fierce)
• Lipocine talks up interim data from small NASH study (Fierce)
• Zafgen has something to cheer as diabetes drug makes the cut in PhII study (Endpoints)
• FDA Accepts Genentech’s Supplemental Biologics License Application for Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for the Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer (Press)
• Aerpio Pharmaceuticals Announces Completion of Patient Dosing in TIME-2b Study of AKB-9778 in Diabetic Retinopathy (Press)
• Isofol Reports Early Tumor Shrinkage in Patients With Colorectal Cancer in Phase 1/2a Open Label Extension Study with Arfolitixorin (Press)
• Nexus Pharmaceuticals announces FDA approval of Busulfan Injection (Press)
• Ipsen Presents the Results of the First in-Human Study of a Recombinant Fast-Acting Neurotoxin (rBoNT-E) at TOXINS 2019 (Press)
• Promentis Pharmaceuticals Announces Commencement of Phase 2 Studies for SXC-2023 Targeting Novel Glutamatergic Mechanism (Press)
• Innovent Announces First Patient Dosed in a Phase III Clinical Trial of Anti-PD-1 Antibody Tyvyt® (Sintilimab injection) as First-line Treatment for Patients with Advanced Gastric Cancer (Press)
• vTv Therapeutics Announces Publication of Comprehensive Data in Science Translational Medicine Detailing the Discovery and Clinical Development of TTP399, including Results of Phase 2 AGATA Study (Press)
• Omeros Finalizes with FDA Clinical Plan for OMS721 Approval in IgA Nephropathy (Press)

• US FDA’s Pre-Cert Pilot for Medical Device Software Moving into Testing Phase (Emergo)
• Becton Dickinson’s fiscal Q1 prelims beat The Street (MassDevice)
• Zoll Medical wins $400m DoD patient monitoring supply contract (MassDevice)
• Hearing aid users often do not see doctors to ensure devices help (Reuters)
• Stimwave touts 6 month MIS SCS trial results (MassDevice) (Press)
• Medtronic kicks off study for pain pump (Drug Delivery) (Press)
• Abbott Finally Pulls the Trigger on Cephea Acquisition (MDDI)
• RFPi wins FDA nod for non-contact blood flow imaging tech (Medical Design & Outsourcing)
• AdvaMed Updates Code of Ethics (FDA Law Blog)
• 3D-printed scaffold helps treat severed spinal cords in rats (Reuters)

• E&C Health Leaders Request Cdc Briefing On Ebola Outbreak In Democratic Republic Of Congo (House E&C)
• No Big Health Policy Moves Expected From Congress (Medpage)
• New Bill Announced to End Marketing Tax Deduction (CHC)
• Supreme Court Denies Certiorari in Amgen v. Sanofi (Patent Docs)
• Ninth Circuit Affirms Federal Preemption Over Dietary Supplement Claims (Drug & Device Law)
• What happens to the Federal Register if there is a government shutdown? (OFR)
• A former Pfizer flight attendant wins the right to sue for discrimination, raising questions about arbitration (STAT)

• FDA Advisory Committee Calendar

• Early access to medicines scheme applications: pending, refused, granted (MHRA)

• Current status of pharmacovigilance regulatory structures, processes, and outcomes in the Asia‐Pacific region: Survey results from 15 countries (PDS)