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

• Gilead Sciences CEO Stepping Down (WSJ) (CNBC) (Bloomberg) (San Francisco Business Times-$)
• Acorda loses bid for U.S. court order halting generic Ampyra sales (Reuters) (Endpoints)
• Convelo Therapeutics, founded on discoveries made at Case Western Reserve School of Medicine, launches publicly (Crain's Cleveland Business) (Fierce)
• Sarepta halts early-stage gene therapy trial for DMD (STAT) (GEN) (Fierce) (Endpoints)
• FDA Panel Nixes Asthma Biologic Nucala for COPD (MedPage Today) (Reuters) (FDA News)
• Hennepin's ketamine studies targeted for federal investigation (Modern Healthcare) (The Washington Post) (Minneapolis Star Tribune-$) (Forbes)
• New Drug Shows Promise in Early Studies to Treat Alzheimer’s (TIME) (NYT) (STAT) (CNN) (CNBC)
• Biogen and Eisai: Let the Alzheimer’s Arguing Commence (Science Translational Magazine)
• Celgene bets on fantastic 5 to save portfolio (BioPharma Dive) (Fierce) (Reuters)
• As Amazon Lurks, Walgreens Launches Digital Marketplace Listing Providers And Prices (Forbes)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• 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)

• 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)

• Medical Devices Safety Update Volume 6, Number 4, July 2018 (TGA)

• 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)

• 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)