Regulatory Focus™ > News Articles > 9 > Recon: Medtronic to Acquire Mazor Robotics for $1.6B; Dozens Lose Sight After Being Injected with Co

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

Posted 21 September 2018 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • 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)
In Focus: International
  • 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-$)
Pharmaceuticals & Biotechnology
  • Opioid crisis started 40 years ago, report argues (NBC)
  • Corbus nets over 600 endocannabinoid-related compounds, planning to develop 1-2 per year (Fierce)
  • Novo Nordisk CSO Says R&D Revamp Reflects New Stem Cell And AI Focus (SCRIP-$)
  • 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 $5 Million Donation to Family Reach to Support Children Battling Cancer and Their Families (Press)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • MicuRx Announces Receipt of FDA’s QIDP and Fast Track Designations for Contezolid and Contezolid Acefosamil (Press)
Medical Devices
  • OMB’s Health Chief: Changes To How CMS Treats Medical Devices Could Come In Next Six Months (IHP-$)
  • 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)
US: Assorted & Government
  • 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 $115M for first fund (MedCity)
  • At Joe Biden's Urging, Airbnb, WeWork, And Others Commit To Help Cancer Patients (Forbes)
  • FDA chief says agency is considering fast-track review for new e-cigs with tech to prevent youth use (CNBC)
  • By the Book: Hip Implant Claims Dismissed in Middle District of Florida (Drug & Device Law)
  • Proposed Doubling of 2019 Marijuana Production Quota Brings DOJ and DEA To A Fork in the Road (FDA Law Blog)
  • Purdue Pharma Must Face N.H.'s Suit Over Opioid Marketing (Law360-$)
Upcoming Meetings & Events
  • 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
Europe
  • 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)
Asia India
  • Ban on 328 FDC drugs to cost Rs. 2,500 crore for pharma companies (PharmaBiz)
Canada General Health & Other Interested Articles
  • ‘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)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
 
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