Recon: Medtronic to Acquire Mazor Robotics for $1.6B; Dozens Lose Sight After Being Injected with Compounded Eye Drug

• Medtronic to Acquire Mazor Robotics (Press) (MassDevice)
• We Can’t Afford the Drugs That Could Cure Cancer (WSJ)
• At Least 68 People Are Nearly Blind After A Botched Drug Was Injected Into Their Eyeballs (BuzzFeed)
• Why Former Novartis CEO Joe Jimenez Joined A Microbiome Startup's Board (Forbes) (Endpoints)
• Sloan Kettering’s Cozy Deal With Start-Up Ignites a New Uproar (ProPublica)
• Dismissing critical reports on patient deaths, FDA says safety/effectiveness of Nuplazid holds up under review (Endpoints)
• Biosafety Reforms Still Lagging at Military Labs (NYTimes) (GAO)
• The Incredible Expanding Universe of Biotech Stocks (LifeSciVC)
• Amgen backs Los Angeles as new Golden State bio hub (Fierce) (Endpoints) (Amgen)
• Parker collaborator Tessa allies with St. Jude, launches a new T cell program for pediatric brain cancer (Endpoints)
• US Challenges World to Intensify Global Fight against Antibiotic Resistance (CDC)
• US burden of Alzheimer’s disease, related dementias to double by 2060 (CDC)
• As States Try To Rein In Drug Spending, Feds Slap Down One Bold Medicaid Move (KHN)
• How one pharmaceutical company is reinventing the clinical trial (STAT)

• Bayer's Jivi OK'd in Japan for hemophilia A (SeekingAlpha) (PMLive)
• How is Hong Kong’s biotech experiment going? A Hong Kong Stock Exchange official weighs in (STAT)
• GlaxoSmithKline fails to warn of pandemic flu vaccine’s alarming safety signal: BMJ report (Fierce) (BMJ)
• Alcohol abuse kills 3 million a year, most of them men: WHO (Reuters) (WHO) (Report)
• Diabetes drugs less affordable, less available in lower income countries (Reuters)
• Uganda to deploy Ebola vaccine if virus spreads from Congo (Reuters)
• NHS wins legal fight against pharma firms over sight-loss drug (The Guardian)
• Novartis drums up EU launch plans as CHMP gives thumbs up to Spark’s gene therapy Luxturna (Endpoints)
• British MPs call for HIV prevention PrEP drugs to be made available on NHS in England (Pharmafile)
• ABPI enters five-year partnership with AHSN (PharmaTimes) (PMLive)
• Korea Lowers Medical Cost For Rare Disease Patients, Eases Off-Label Use Rules (Pink Sheet-$)
• Lonza invests $418m in two biomanufacturing solutions (BioPharmaReporter)
• Biosimilar Tipping Point: Five Questions For Henlius CEO (SCRIP-$)
• Pierre Fabre combo follows up US approval with EC nod (PharmaLetter-$)

• Opioid crisis started 40 years ago, report argues (NBC)
• Corbus nets over 600 endocannabinoid-related compounds, planning to develop 1-2 per year (Fierce)
• Novo Nordisk CSO Says R&D Revamp Reflects New Stem Cell And AI Focus (SCRIP-$)
• GTx execs’ sole drug fails the lead indication study in a painful setback — shares smashed (Endpoints)
• Ex-Cascadian chief Scott Myers lands at BioClin; Kodiak woos Genentech vet Jason Ehrlich for CMO role (Endpoints)
• The Economics Of Drug Shortages: US FDA Seeks Broad Input (Pink Sheet-$)
• Exicure plans checkpoint combo after TLR9 drug clears early test (Fierce)
• Trial takes FibroGen’s renal anemia drug closer to EU filing (Fierce)
• Flea, tick pills can cause nerve reactions in pets, FDA warns (NBC)
• Ubiome Moving Into Therapeutics With $83m Series C (BioCentury)
• Y-mAbs Raises $96m In Upsized IPO (BioCentury) (Endpoints)
• Ropin' in ALS (Nature)
• Reversing muscle degeneration (Nature)
• When a CAR becomes a tank (Nature)
• Bacterial therapeutic steps into the breach (Nature)
• Therapeutic approaches to Huntington disease: from the bench to the clinic (Nature)
• Opiant Gets BARDA Grant For Intranasal Opioid Antagonist (BioCentury)
• Management Tracks: Garland To Lead Portola; Gallagher Joining Abingworth (BioCentury)
• AbbVie Announces $5 Million Donation to Family Reach to Support Children Battling Cancer and Their Families (Press)

• MicuRx Announces Receipt of FDA’s QIDP and Fast Track Designations for Contezolid and Contezolid Acefosamil (Press)

• OMB’s Health Chief: Changes To How CMS Treats Medical Devices Could Come In Next Six Months (IHP-$)
• For A New Device To Treat Maternal Bleeding, A Young Entrepreneur's Big Step Was Passing The Torch (Forbes)
• Report: Google’s Nest looking to expand into healthcare (MassDevice)
• FDA: Hurricane Florence should not affect medtech supply chain (MassDevice)
• FDA puts $7m into L.A. pediatric devices consortium (MassDevice)
• AVITA Medical Announces FDA Approval of the RECELL® System for the Treatment of Severe Burns in the U.S. (Press)
• Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters (FDA)
• Paladin Carotid PTA Balloon with Embolic Protection Filter Cleared by FDA (Medgadget)
• b-ONE Ortho Receives U.S. FDA 510(k) Clearance for Total Hip System (Press)

• Medicare Payments for Clinical Diagnostic Laboratory Tests in 2017: Year 4 of Baseline Data (HHS OIG)
• Ex-FDA Chief Hamburg Says AAAS Will Take On Harassment (BioCentury)
• Andy Slavitt’s Town Hall Ventures secures $115M for first fund (MedCity)
• At Joe Biden's Urging, Airbnb, WeWork, And Others Commit To Help Cancer Patients (Forbes)
• FDA chief says agency is considering fast-track review for new e-cigs with tech to prevent youth use (CNBC)
• By the Book: Hip Implant Claims Dismissed in Middle District of Florida (Drug & Device Law)
• Proposed Doubling of 2019 Marijuana Production Quota Brings DOJ and DEA To A Fork in the Road (FDA Law Blog)
• Purdue Pharma Must Face N.H.'s Suit Over Opioid Marketing (Law360-$)

• FDA Advisory Committee Calendar
• House E&C Committee Hearing - Better Data and Better Outcomes: Reducing Maternal Mortality in the U.S. – 27 September 2018
• Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting – 1 November 2018

• Mobile apps could offer cheap route to FMD compliance (Pharmaceutical Journal)
• Therapeutic Products Ordinance Package IV: Publication of the ordinances (Swissmedic)
• Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device (EMA)
• Questions & answers on Article 31 non-pharmacovigilance referrals (EMA)

• Roche invests in Chinese R&D unit (PharmaLetter-$)
• Daiichi to test cancer drug combo (PharmaTimes)

• Ban on 328 FDC drugs to cost Rs. 2,500 crore for pharma companies (PharmaBiz)

• Switzerland to Canada: GSK transfers Voltaren tech for local supply (InPharmaTechnologist)

• ‘Latent’ Tuberculosis? It’s Not That Common, Experts Find (NYTimes)
• Medical journal retracts six articles from Cornell University professor (NBC)
• Scientists Create Immature Human Eggs From Stem Cells (NPR)