Regulatory Focus™ > News Articles > 7 > Recon: Gilead CEO Stepping Down; Biogen and Eisai Alzheimer’s Trial Results Raise Questions

Recon: Gilead CEO Stepping Down; Biogen and Eisai Alzheimer’s Trial Results Raise Questions

Posted 26 July 2018 | By Ana Mulero 

Recon: Gilead CEO Stepping Down; Biogen and Eisai Alzheimer’s Trial Results Raise Questions

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

In Focus: US In Focus: International
  • Roche Lifts Forecast as New Drugs Take Over to Drive Growth (Bloomberg) (Reuters) (Endpoints)
  • Chinese biotech firm Ascletis raises $400 million in HK IPO: sources (Reuters) (Endpoints)
  • AstraZeneca’s New Medicines Buoy Second-Quarter Results (Bloomberg) (PMLiVE) (Reuters)
  • Bristol-Myers to get negative CHMP opinion on renal cancer drugs (Reuters)
  • NICE backing for Keytruda in classical Hodgkin lymphoma (PharmaTimes)
  • Viral content: vaccine scandal test Beijing's grip on information control (Reuters)
  • Which multinational drugmaker grew most rapidly in H1? (Korea Biomedical Review)
  • The ICH S9 Q&A presentation available now on the ICH website (ICH)
Pharmaceuticals & Biotechnology
  • Regeneron’s Billionaire Founder Battles The Drug Pricing System (Forbes)
  • Did AbbVie unfairly thwart competition by creating a ‘patent thicket’ around its Humira drug? (STAT-$)
  • GSK: we won’t be splitting up any time soon (PMLiVE)
  • Pharma's middlemen see shares suffer as challenges grow (Reuters)
  • Amgen's new migraine drug hits insurance hurdles (Reuters)
  • AstraZeneca joins U.S. drug price freeze for rest of 2018 (Reuters)
  • Celgene bows to White House pressure after raising prices for cancer drug (Washington Examiner)
  • Astra and Roche Get New Growth Engines as Older Drugs Fade (Bloomberg)
  • Why Roche acquired Foundation Medicine and Flatiron Health (Business Insider-$)
  • Fueling an epidemic: Exposing the financial ties between opioid manufacturers and third party advocacy groups (Report)
  • Bristol-Myers Squibb Reports Second Quarter Financial Results (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Stronger-than-expected sales of Botox lift Allergan (The Pharma Letter-$) (Fierce) (Reuters)
  • Next-generation ALS drug silences inherited form of the disease in animal models (NIH)
  • Now a three-time loser, selumetinib continues to cause headaches as AstraZeneca dumps a failed PhIII (Endpoints)
  • Single Course of Antibiotics Early in Life May Increase Type 1 Diabetes Risk (GEN)
  • Determination that Metaxalone Tablets, 640 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)
  • Inventor of Viagra raises funding to treat 7,000 rare diseases (The Telegraph) (Forbes)
  • ICU Medical, Inc., et al.; Withdrawal of Approval of 31 Abbreviated New Drug Applications (FDA)
  • Bio-Thera Solutions Initiates Phase I Clinical Trial for BAT-1806, a Proposed Biosimilar of Actemra (Tocilizumab) (Press)
  • Sandoz Amends ANDA to Not Seek Approval for Generic Version of OMIDRIA Until Patents for Omeros’ Drug Expire (Press)
  • Consumer Information on: Minimed 670G System - P160017/S031 (FDA)
  • UPDATE: Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - Potential Lack of Treatment (Shock) Delivery Due to Device Failure: FDA Safety Communication (FDA)
  • Examples of Pre-Market Submissions that Include MMAs Cleared or Approved by FDA (FDA)
  • FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer (FDA)
Medical Devices
  • Durable medical equipment firm owner admits to $9.8 mln Medicaid fraud (Reuters)
  • Boston Scientific Chips Away At Nevro Patents, Beats IP Suit (Law360-$)
  • Boston Scientific delays Spectra WaveWriter trial (MassDevice)
  • AdvaMed Says Device-Tax Repeal Shy Just 2 Votes In Senate, Expects Passage (Inside Health Policy-$)
  • Genentech touts positive data for tiny, refillable eye implant (DDBN)
  • Mauna Kea Technologies Reports Second Quarter and First Half 2018 Sales (Press)
  • Asuragen Expands AmplideX Technology and Product Line with Launch of PCR/CE SMN1 Kit (Press)
  • MED-EL USA Obtains FDA De Novo Clearance for BONEBRIDGE Bone Conduction Implant System (Press)
  • LifeSignals Announces FDA Clearance of Health Care Vital Sign Wireless Monitoring Patch and ECG Application (Press)
  • Cepheid Receives FDA Clearance and CLIA Waiver for Xpert Xpress Flu/RSV Test (Press)
  • PerkinElmer’s EUROIMMUN Receives FDA Clearance for ANCA IFA and EUROPLUS Granulocyte Mosaic Assays Using EUROPattern Microscope (Press)
  • Treace Medical Announces Presentation of Positive Clinical Data Supporting Lapiplasty 3D Bunion Correction for the Surgical Management of Bunion Deformities (Press)
  • Abbott Begins U.S. Pivotal Trial for the Tendyne Mitral Valve Replacement System to Treat Patients with Heart Valve Disease (Press)
US: Assorted & Government
  • In Philadelphia, Only 16% Of New Pharma Plaintiffs Are From Pennsylvania (Forbes)
  • Top health care CEOs made $1.7 billion last year (Axios)
  • Google Wants To Build Headphones That Track Your Health — And It Might Even Pay You For The Privilege (CB Insights)
  • Powerful people in health care are finding a new landing pad: Google (STAT)
  • CMS proposes slashing clinic visit payments as part of site-neutral policy (Modern Healthcare)
  • Microsoft health unit is a 'multi-billion dollar business,' medical chief says (CNBC)
  • Tickborne diseases are likely to increase, say NIH officials (NIH)
Upcoming Meetings & Events Europe
  • Clinigen buys global rights to Horizon’s Imukin (PharmaTimes)
  • Ipsen delivers first-half 2018 sales growth of 21.5% (The Pharma Letter-$) (Press)
  • Breast implants, all types, makes and models – Continue to report suspected cases of Breast Implant Associated - Anaplastic Large Cell Lymphoma (MDA/2018/027) (MHRA)
  • REVA Enters Peripheral Artery Disease Space With First-Ever CE Mark of a Bioresorbale Scaffold for Below the Knee Therapy (Press)
Asia
  • Regulator fails to screen out 141 prescriptions of banned hypertension drug (Korea Biomedical Review)
  • 3M Korea launches all-in-one catheter securing system (Korea Biomedical Review)
  • KEYTRUDA (pembrolizumab) is the First Anti-PD-1 Therapy Approved in China for Advanced Melanoma (Press)
India
  • US wants to reduce trade deficit with India soon, says official (Financial Express) (The New Indian Express)
  • Panel recommends ban on 343 fixed dose combination medicines (Economic Times)
  • Sanofi India net surges by 35.1% in Q2 to Rs. 100 cr, interim dividend of 180% (Pharmabiz)
  • Dr. Reddy's Laboratories Announces the Launch of Hervycta (trastuzumab biosimilar) in India (Press)
Australia
  • Medical Devices Safety Update Volume 6, Number 4, July 2018 (TGA)
Canada
  • Health Canada ordered to release clinical trial information to researcher without confidentiality restrictions (Lexology-$)
  • Canada’s Inversago raises $7M to target cannabinoid receptors (Fierce)
  • Government of Canada Invests $30 Million to Support Health Care Services in Yukon (Health Canada)
General Health & Other Interesting Articles
  • Young people have the most medical debt (Axios)
  • How bad data is worse than no data at all (Health Data Management)
  • Why Men Report Having Many More Sexual Partners Than Women: Study (Forbes)
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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