Recon: AbbVie Plans New San Francisco R&D Hub; Merrimack to Cut 60% of Staff

• AbbVie hatches plans for a major new R&D hub close to its partners in Bay Area’s buzzy Oyster Point (Endpoints) (SF Business Times)
• Meet the New Agenda Setters in the House (WSJ) (NBC)
• Dem overtures to Trump on drug pricing worry pharma (The Hill) (Fierce) (STAT)
• 8 burning questions for pharma, as Washington braces for a health policy shakeup (STAT)
• Sage depression drug to cost between $20K and $35K, if approved (BioPharmaDive)
• Merrimack axes 60% of staff, mulls sale after clinical flops (Fierce) (Endpoints)
• Jazz’s Vyxeos rollout hit a wall in Q3. What’s the holdup? (Fierce) (Pharmafile)
• Harvard Medical School receives record $200 million gift for research — and an incubator (STAT)
• Behind the patent thicket: tactics AbbVie allegedly used to thwart biosimilar versions of Humira (STAT) (Evaluate)
• Voyager’s shares sink after execs say FDA has reversed course on an accelerated filing for its gene therapy (Endpoints)
• Opinion: The FDA Was Wise to Approve a New Opioid (WSJ)
• Endo targets 2020 for launch of cellulite treatment (Reuters)
• Superbugs pose a dangerous, $65 billion threat to the US health-care system (CNBC)
• Genentech sues indicted ex-employees and biosim maker over trade secrets theft (Fierce) (BioCentury)

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• Biosimilar drugs promise to slash health-care costs in rich countries (The Economist)
• AstraZeneca shares surge as new drugs spark hope of growth (Financial Times) (Endpoints) (PMLive)
• AZ drops midstage cancer drug vistusertib (Fierce)
• Hikma and Vectura agree to develop generic rival to asthma drug (Financial Times)
• Pharma Slammed Over European Hospital Drug Shortages (Pink Sheet-$)
• Six in ten UK hospital pharmacists encounter medicines shortages daily, finds survey (Pharmaceutical Journal)
• Speedy NICE Support For Eisai's Lenvima In Liver Cancer (SCRIP-$)
• MedCity moves to foster U.K. advanced therapy collaborations (Fierce)
• Israel's Intec Pharma eyes revenue from Parkinson's drug in 2019 (Reuters)
• Uganda is vaccinating for fear of Ebola virus spread (NBC)
• China Set To Become Global Drug Innovation Center (SCRIP-$)
• EMA Explains Use Of Extrapolation In Developing Medicines For Children (Pink Sheet-$)
• AMR superbugs expected to kill 90,000 Britons in the next 30 years (Pharmafile)
• WHO supports district health facilities in Yemen to respond to basic health needs (WHO)

• Active Ingredient In Marijuana Reduced Alzheimer's-Like Effects In Mice (NPR)
• Increasing the Participation of Pregnant Women in Clinical Trials (JAMA)
• Novel antibiotic shows promise in treatment of uncomplicated gonorrhea (NIH)
• BioMarin eyes 2019 FDA filing for haemophilia A gene therapy (PMLive)
• Immunotherapy Combinations in Multiple Myeloma — Known Unknowns (NEJM)
• GSK execs change their tune as AZ, Sanofi heap pressure on respiratory hopeful Nucala (Fierce)
• Bicycle Therapeutics picks up former Pfizer head as new SVP of Pre-Clinical Development (Pharmafile)
• The Strategic Advantages of Early Access Programs (Pink Sheet-$)
• Drug Prices After the Midterms: Five Crucial Implications of Pharmacy Benefit Design (Drug Channels)
• US FDA Ends Nearly 2-Year Drought In Biosimilar Action Package Postings (Pink Sheet-$)
• Mylan overhaul of West Virginia plant has a ways to go (Fierce)
• Recro Pharma expands CDMO business in Georgia (Fierce)
• GlaxoSmithKline, Novartis and more pharmas made big bets on digital health in Q3 2018 (mobihealthnews)
• Eyes on neuro breakthroughs, newcomer Biomatics adds biotech vets and $300M with second fund (Endpoints)
• Eli Lilly sweeps the rest of the BACE work out of the pipeline following their latest major setback on Alzheimer’s (Endpoints)
• GSK’S Systemic STING Agonist Could Overcome Delivery Hurdles (BioCentury)
• InCarda grabs a $42M round to back PoC study for their inhaled cardio drug (Endpoints)
• Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions (FDA)
• The Medicines Company Reports Third-Quarter 2018 Results (Press)
• Seres Therapeutics Reports Third Quarter Financial Results (Press)
• TherapeuticsMD Announces Third Quarter 2018 Financial Results (Press)
• Kala Pharmaceuticals Reports Third Quarter 2018 Financial Results (Press)
• BioCardia Reports Third Quarter 2018 Financial Results and Business Highlights (Press)
• Magenta Therapeutics Reports Third Quarter 2018 Financial Results (Press)
• Deciphera Pharmaceuticals, Inc. Announces Third Quarter 2018 Financial Results (Press)
• Ligand Reports Third Quarter 2018 Financial Results (Press)
• Verastem Oncology Reports Third Quarter 2018 Financial Results (Press)
• Ocular Therapeutix™ Reports Third Quarter 2018 Financial Results (Press)
• Tedor Pharma, Inc., et al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications (FDA)
• Determination That AXIRON (Testosterone) Transdermal Metered Solution, 30 Milligrams/1.5 Milliliter Actuation, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)

• New England Journal of Medicine publishes positive detailed results from Praluent® (alirocumab) Injection cardiovascular outcomes trial (Press)
• Urovant Sciences Completes Patient Enrollment in Phase 3 Pivotal Trial Studying Vibegron for Overactive Bladder (Press)
• FLX Bio Highlights Phase 1 Data for FLX475 at SITC 2018 (Press)
• Visterra Initiates Phase 1 Clinical Study of VIS649 (Press)
• Evofem Biosciences Completes Phase 3 Clinical Trial of Amphora for Prevention of Pregnancy (Press)
• ArQule to Present Clinical and Preclinical Data for ARQ 751 at the 30th EORTC/AACR/NCI Symposium (Press)

• FTC clears Stryker, K2M tie-up early (MassDevice)
• 8 Things You Should Know about the EU MDRs (MDDI)
• The Diagnostic Artificial Intelligence Speedbump Nobody’s Mentioning (Drug & Device Law)
• May FDA Regulate Medical Devices As If They Were Drugs? (FDA Law Blog)
• How medical devices like pacemakers and insulin pumps can be hacked (CBS)
• Buffett-owned DaVita plunges 9% after soaring on midterm elections (CNBC)
• Insulet inks deal with Samsung to develop smartphone-controlled Omnipod (Drug Delivery)
• Medtronic Begins Renal Denervation Study for High Blood Pressure Patients Prescribed Anti-Hypertensive Medication (Press)
• Mazor posts Q3 miss, wins FDA nod for Mazor X Stealth edition (MassDevice)
• DexCom Continues to Shine Despite Growing Competition in CGM (MDDI)
• Class 1 Device Recall Reinforced Dual Lumen Cannula (FDA)
• VIVA 2018 Roundup: Surmodics reports positive one-year data for SurVeil drug-coated balloon (Drug Delivery)

• Politics and Pandemics (NEJM)
• Ranbaxy Abused Generic Drug Application Process, Suit Says (Law360-$)
• Biopharma Co. Hit With Suit Over Directors' 'Excessive' Pay (Law360-$)
• Calif. Appeals Panel Revives Suits Over Diabetes Drugs (Law360-$)
• When Medicaid Expands, More People Vote (NYTimes)
• 10 Health Law and Policy Takeaways from the Midterm Election (Harvard Bill of Health)
• The costs of heroin and naloxone: a tragic snapshot of the opioid crisis (STAT)
• Judge raises patent award against Cochlear Ltd. to $268M (MassDevice)

• FDA Advisory Committee Calendar

• NICE appoints experienced pharma consultant as Director of NICE Scientific Advice (Pharmafile)
• New alliance strives to advance human-based drug evaluation (PharmaTimes)

• Hazard Alert: SQ-RX Model 1010 Pulse Generator – used with Boston Scientific S-ICDs (TGA)

• Notice: ICH Guidance on Reporting Adverse Reactions to Marketed Health Products (Health Canada)