Recon: GSK Buys Out Novartis Stake in Consumer Unit for $13B

Posted 27 March 2018 | By Ana Mulero 

Recon: GSK Buys Out Novartis Stake in Consumer Unit for $13B

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • GSK Buys Novartis’s Stake in Health-Care Unit for $13 Billion (WSJ) (Axios) (Reuters)
  • Gilead Sciences' revenue may be shrinking, but CEO John Milligan just got an 11% raise (Fierce) (Axios) (San Francisco Business Times-$) (Endpoints)
  • Aetna to provide pharmacy rebates for some people (Axios) (Bloomberg) (CNBC) (STAT-$)
  • Impax settles retailers' antitrust cases over generic drug's delay (Reuters) (Fierce)
  • CRISPR Restored: Scientists Reverse Finding That Gene Editing Technology Had Flaws (Forbes)
  • AnaptysBio plans phase 2b peanut allergy trial after taking positives from POC data (Fierce) (STAT-$) (Endpoints)
  • Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments (FDA)
  • Texas Stem Cell Law Opens Door for Controversial Treatments (The Scientist)
  • U.S. jury orders AbbVie to pay $3 million in AndroGel retrial (Reuters) (Law360-$) (Fierce)
In Focus: International
  • Novartis CEO Aims to Double China Sales on Faster Drug Approvals (Bloomberg) (Business Times)
  • Glaxo to Examine Sale of $3.1 Billion India Consumer Unit Stake (Bloomberg) (Hindustan Times)
  • China’s biotech pipeline is brimming with PD-1/L1 checkpoints. Are they really needed? (Endpoints)
  • China’s Adagene raises $50M to take anticancer antibodies into the clinic (Fierce) (Endpoints)
  • Singapore’s Aslan Pharma lines up an $86M IPO to fund pivotal cancer drug studies (Endpoints) (Fierce)
  • World leaders have the power to end TB. They must seize the moment (STAT)
  • Merck KGaA adopts Medisafe medication adherence tool for patients with chronic conditions (MedCity News)
  • Iranian hackers steal academic research worth billions from US universities, private companies (Endpoints) (BioCentury)
  • European Medicines Agency closed 29 March to 2 April 2018 (EMA)
Pharmaceuticals & Biotechnology
  • Any potential Alcon decision will be made in first half of 2019, Novartis CEO says (CNBC)
  • GSK's $13 Billion Novartis Deal Is Only Just the Start (Bloomberg-$)
  • FDA: Many Questions on Novel Opioid Withdrawal Drug (MedPage Today)
  • Shkreli To Appeal Fraud Conviction, 7-Year Prison Sentence (Law360-$)
  • FDA Center for Drug Evaluation and Research Manual of Policies and Procedures for new drug applications and biologics license applications (FDA)
  • Doctors expect enthusiasm for Allergan's high-flying Zeltiq to fade: survey (Fierce)
  • Prices for widely prescribed Medicare Part D drugs rose 12 percent annually, but mind the caveat (STAT-$)
  • Here’s the slide deck Moderna uses to defend its $7.5 billion valuation (STAT-$)
  • The top-performing biotech stock this year has surged on flimsy data (STAT-$)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Esperion's drug clears study as add-on cholesterol treatment (Reuters) (Fierce)
  • Bristol-Myers' Opdivo-Yervoy combo scores again at FDA, this time in colorectal cancer (Fierce) (Press)
  • Lies, damn lies and statistics: A Stanford wiz says P<0.05 offers deceptive evidence of biopharmas' drug claims (Endpoints)
  • Richard Lehman’s journal reviews (The BMJ)
  • CRISPR Adapted to Prevent Unwanted Mutations (GEN) (Science Daily)
  • Scrip's Rough Guide To IL-2: Mother Of All Cytokines (Pharma intelligence-$)
  • What makes a well-controlled clinical trial? (MassDevice)
  • Breckenridge Pharmaceutical, Inc. Announces Final Approval of its ANDA Entecavir tablets (Baraclude) (Press)
Medical Devices
  • A Brooklyn-based startup that's building cheaper robots to democratize biotech just closed a $10 million funding round (Business Insider)
  • Medical Device Co. Must Face Claims In Hip Implant MDL (Law360-$)
  • NuVasive Investors Settle Kickback Class Action For $7.9M (Law360-$)
  • Gener8tor Launches New Med-Tech Accelerator in Minneapolis (AMERICANINNO)
  • Sanofi’s high-capacity insulin pen wins FDA nod (Drug Delivery Business News) (Press)
  • Adherium Receives U.S. 510(k) Clearance for Over-the-Counter Sales of its Smartinhaler Sensor (Press)
  • Vaica's SimpleMed Digital Health Solution Contributes to 66% Improvement of Medication Adherence Amongst Young Kidney Transplant Recipients in McGill-Led TAKE-IT Clinical Study (Press)
  • The Evolving State of Medical Device Cybersecurity (AAMI)
  • Laboratory for Advanced Medicine Launches AI-based Cancer Test (BioCentury)
US: Assorted & Government
  • Comment Request; Guidance for Industry on Compounded Drug Products That Are Essentially Copies of an Approved Drug Product Under Section 503B of the FD&C Act (FDA)
  • Antitrust Group Calls For DOJ To Block CVS-Aetna Deal (Law360-$)
  • Health, medical groups sue FDA over e-cigarette rule delay (Reuters)
  • Medicaid Drug Payment Scrutiny Picking up Steam (2) (Bloomberg)
  • McCaskill rips into price hikes for brand prescriptions (Axios)
  • Editorial: Stop soaking taxpayers for Medicaid drugs (The Columbus Dispatch)
  • Five Takeaways About Cigna's Strategy for Express Scripts (Drug Channels)
Upcoming Meetings & Events Europe Asia
  • Shanghai drugmaker Hua hauls in $117M megaround, with plans for hefty Hong Kong IPO (Endpoints) (Press)
  • Sanofi’s Keeney On Early-Stage Assets, 'Open Dialogue' With Asian Start-Ups (Pharma intelligence-$)
  • AveXis Gene Therapy Awarded SAKIGAKE Designation for Spinal Muscular Atrophy Type 1 (Press)
  • Japan Nod Positive For Hemlibra But Shadows Linger (Pharma intelligence-$)
  • South Korea confirms foot-and-mouth disease at hog farm (Reuters)
  • Roivant snags Chinese rights to Nabriva’s antibiotic in $95M deal (Fierce)
India
  • India’s apex research institute floats a ‘recipe-for-TB patients’ contest (Hindustan Times)
  • Whatever Happened to India's National Free Medicines Scheme? (The Wire)
  • Charted: India’s shocking attitudes towards mental illness (Quartz)
Australia
  • Pelvic mesh implants: How tracking vehicle parts is easier than medical devices (ABC News)
  • Monash Health moves to eliminate pagers with a 21st century communication tool designed to improve after-hour care (Healthcare IT News Australia)
  • First sports 'brain bank' launched (The West Australian)
  • New strategy to future-proof nation’s health workforce (The Australian)
Canada
  • Waning immunity behind the comeback of mumps in Canada (CTV News)
  • Valeant Canada Announces Health Canada Approval of CONTRAVE Extended-release Tablets for Chronic Weight Management in Adults (Press)
  • The Honourable Ginette Petitpas Taylor, Minister of Health announces new measures to reduce barriers to treatment and $231 M to address the opioid crisis (Health Canada)
General Health & Other Interesting Articles
  • Here’s One Issue Blue and Red States Agree On: Preventing Deaths of Expectant and New Mothers (CNBC)
  • Your rubber ducky is probably crawling with bacteria, scientists say (STAT)
  • Why Houston and other cities want nothing to do with the massive national opioid lawsuit (STAT)
  • Aetna CEO: Warren Buffett's 'tapeworm' analogy fits — health-care costs squeeze the economy for trillions (CNBC)
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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