Recon: Ex-GSK CEO to Lead Optum; China Creates New Drug Regulator

Posted 13 March 2018 | By Ana Mulero 

Recon: Ex-GSK CEO to Lead Optum; China Creates New Drug Regulator

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

In Focus: US In Focus: International
  • China creates new drug regulator in biggest government overhaul in years (Fierce)
  • NICE minded to reject Keytruda for classical Hodgkin lymphoma (PharmaTimes)
  • Netherlands biotech Escalier gets $19M for pivotal dermatology tests (Fierce)
  • Doctors across Zimbabwe go on strike over pay, drug shortages (Reuters)
  • Namibia records first listeria case after it kills 180 in South Africa (Reuters)
  • Bhutan reports outbreak of severe H5N1 bird flu: OIE (Reuters)
  • Finland Fimea’s final accounts and annual report for 2017 have been published (Fimea)
  • FP9 Public Consultation on EU funds in the area of investment, research & innovation, SME's and single market (MSF Access Campaign)
  • SanBio Reaches Agreement on Manufacture of Regenerative Medicine Product SB623 with Hitachi Chemical (Press)
Pharmaceuticals & Biotechnology
  • Roche CEO says new drugs will offset biosimilar incursions (Reuters) (Press)
  • FDA sends Hikma back to the clinic with generic Advair (Fierce)
  • Get ready for a drop in branded drug spending this year, thanks to rebates and discounts: report (Fierce) (The Pharma Letter) (STAT-$) (Biopharma Dive)
  • ‘Why Is Drug Spending So High?’ Is the Wrong Question (Morning Consult)
  • Centene Invests Stake In Pharmacy Benefit Manager RxAdvance (Forbes) (St. Louis Post-Dispatch)
  • 32-Year-Old Professor Raises $50 Million To Make Drugs To Control Genes (Forbes)
  • Intec Pharma Partners with LTS for Manufacture of Accordion Pill Carbidopa/Levodopa for Treatment of Parkinson's Disease (Press)
  • GSK’s 2017 annual report (Report)
  • Biohaven bullish on CGRP market with new Bristol-Myers terms (Biopharma Dive)
  • Increased biologics business demand drives Charles River expansions (Fierce) (Press)
  • Vicore Pharma's Holding I-Tech Strengthens Supply Chain With Strategic Acquisition (Reuters)
  • Trump's drug-price crackdown misses the mark, experts say (Washington Examiner)
  • From app store to drug store, digital health is redefining pharma’s pipeline (STAT)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • The TRiC chaperonin controls reovirus replication through outer-capsid folding (Nature) (Press)
  • FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab) for Treatment of Advanced Cervical Cancer (Press)
  • Study Links Type of Blood Pressure Medication to Increased Risk of Death (Press)
  • Testing for Calcium in the Coronary Arteries Provides a Better Way to Predict Heart Attack Events than Stress Testing Alone, News Study Finds (Press)
  • Stress of Open-Heart Surgery Significantly Reduces Patients’ Vitamin D Levels, But Supplementation Before and After Surgery Helps, Study Finds (Press)
  • Mayo Clinic’s clinical trial matching project sees higher enrollment in breast cancer trials through use of artificial intelligence (Press)
  • Heart Attack Risk Increases with Six-Month Dual Antiplatelet Therapy (American College of Cardiology)
  • Researchers discover ‘new line of attack’ on triple negative breast cancer (PharmaTimes)
  • Citizen Petition from Spear Pharmaceuticals, Inc (Petition)
  • ACC: Novartis' canakinumab cuts CV risks in patients with kidney disease, diabetes by up to 18% (Fierce)
  • Protalix’ oral anti-TNF drug hits the mark in phase 2 ulcerative colitis trial (Fierce) (Endpoints News)
  • AbbVie sweeps back-to-back PhIIIs for uterine fibroid patients, adding to elagolix’s blockbuster rep (Endpoints News)
  • Proteostasis stock soars on cystic fibrosis breakthrough status (Endpoints News) (Press)
  • Avillion Signs Co-Development agreement With Astrazeneca's unit Pearl Therapeutics (Reuters)
  • Scientists study how environmental and social change affects the spread of infection (Medical Research Council)
  • Institutional Research Misconduct Reports Need More Credibility (JAMA)
  • Rare Disease Groups Welcome FDA’s Embrace of ‘Real World’ Data in Clinical Trials (Huntington’s Disease News)
  • NIH scientists describe potential antibody approach for treating multidrug-resistant Klebsiella pneumoniae (NIH)
  • Amid efforts to expand naloxone access, a controversial new study questions its value (STAT)
  • SCORR Marketing and Applied Clinical Trials Release Survey Report on Recruiting and Retaining Clinical Research Employees (Press)
  • Millions in fines are adding up as clinical trial information goes unreported (STAT-$)
Medical Devices
  • FDA panel to make sense of implanted glucose meter (EP Vantage)
  • Diagnostic errors pose greatest patient safety risk (Modern Healthcare)
  • Illumina Names Dr. Phil Febbo Chief Medical Officer (Press)
  • Unsealed Abiomed whistleblower suit reveals claims of retaliation (MassDevice)
  • FDA clears shutdown of Lap-Band study for Apollo Endosurgery (MassDevice)
  • Medical Devices; Exemption From Premarket Notification; Class II Devices; Over-the-Counter Denture Repair Kit (FDA)
  • Intec Pharma partners for manufacture of ‘accordion pill’ for Parkinson’s disease (Drug Delivery Business News)
  • The Case for Product Management Education in Clinical Training (NEJM)
  • Medical Device Co. Says Atty's Consultant Scam Cost It $1.8M (Law360-$)
  • Exactech Receives 510(k) Clearance for Equinoxe Stemless Shoulder (Press)
  • BioVentrix Announces First Patient at Cardiovascular Institute of the South Successfully Treated in IDE Study of Revivent TC TransCatheter Ventricular Enhancement Treatment (Press)
  • TAE bags $40M to take targeted radiotherapy mainstream (Fierce)
  • Intermountain launches mental health tech company (Healthcare IT News)
  • Continuous Wearable Monitoring Analytics Predict Heart Failure Decompensation: The Link-HF Multi-Center Study (Journal of the American College of Cardiology)
  • QIAGEN and Natera Partner to Develop Cutting-Edge Genetic Testing Assays for Use on QIAGEN’s GeneReader NGS System (Press)
  • Automated diabetic retinopathy detection in smartphone-based fundus photography using artificial intelligence (Nature) (Press)
  • Median Technologies and the Nice University Hospital (CHU De Nice) Announce Agreement to Advance Lung Cancer Screening with Artificial Intelligence (Press)
  • Hackers take aim at common medical devices (Star Tribune)
US: Assorted & Government
  • Request for comments: Patient-Focused Drug Development on Opioid Use Disorder; Public Meeting (FDA)
  • Patient Orgs Oppose Right to Try (Letter)
  • US Universities Oppose Right to Try (Letter)
  • Key Democrat comes out against 'right to try' bill (The Hill)
  • Right-to-try drug bill could needlessly raise patients' hopes, experts say (Politico)
  • Why Lawmakers Must Vote Down Right to Try (The Health Care Blog)
  • Statement from the Press Secretary on the Global Health Security Agenda (White House) (report)
  • The G.O.P. Accidentally Replaced Obamacare Without Repealing It (NYT)
  • Bipartisan bill would give DEA more power in setting opioid quotas (The Hill)
  • Pallone introduces legislation to empower FDA to combat illicit opioid importation (Press)
  • New FTC Makeup to Continue Robust Health-Care Enforcement (Bloomberg)
  • Can CVS's Acquisition Of Aetna Live Up To Its Price Tag? (Forbes)
  • Federal judge throws out Massachusetts challenge to Trump birth control rules (The Hill) (Reuters)
  • 11th Circ. Creates Headaches For Judges, Defense Attorneys (Law360-$)
  • Insurer says it’s staying in ACA markets because of GOP tax law (Axios)
  • Some good news for 2018 Senate Dems on health care (Axios)
  • Health insurer CEOs see some significant pay bumps in 2017 (Modern Healthcare)
  • Cigna-Express Scripts deal unlikely to benefit consumers (Modern Healthcare)
  • Trump wants to liberalize health data. Easier said than done. (Vox)
  • GAO Report Confirms the Obvious: Food Safety Has Been Driving the Bus at FDA’s FVM Program (FDA Law Blog)
Upcoming Meetings & Events Europe
  • Field Safety Notice - 5 to 9 March 2018: Summary List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 March 2018 (MHRA)
  • Class 3 Medicines Recall: Lynparza capsule 50mg: AstraZeneca is recalling batch NG327 as the level of olaparib polymorphic form L exceeds the registered specification limit. (MHRA)
  • Siri and Alexa are already changing how Europeans get health info, DRG Digital | Manhattan Research data show (Press)
  • Oxford BioMedica intends to obtain financing for further expansion (GMP News)
  • Check-Cap Initiates EU Post Approval Study Using Advanced C-Scan (Press)
  • Kuros Biosciences obtains European patent covering osteoinductive materials (Press)
  • EBRD issues its first 'health bond' worth 317 million zlotys (Reuters)
  • Philips opens Southeast Asia’s first Sleep and Respiratory Education Center in Singapore (Press)
  • Medifirst Solutions Announces an Update for China Distribution (Press)
  • Medical device maker gets sales approval in Israel (Korea Biomedical Review)
  • United Biopharma expands in China with a MAb facility in Yangzhou (The Pharma Letter-$)
  • GSK Korea reports successful sales of Avodart in Japan (Korea Biomedical News)
  • Low-quality trials behind popular diabetes combo pills in India (Reuters)
  • Health bodies push for compulsory licence for two drugs on MDR-TB (Business Standard)
  • Indian drugmakers cashing in on US market as more big-selling drugs gain generic competitors (The Pharma Letter)
  • Health sector could create jobs on massive scale: Public Health Foundation of India (The Economic Times)
  • Guided Therapeutics Achieves Regulatory Approval for Sale in India (Press)
  • Consideration of the directions of the Hon’ble Supreme Court of India (Notice)
  • Indian pharma cos to get equipped to address unannounced US FDA audit, warning letters (Pharmabiz)
  • Indian doctors suspended after severed leg used as pillow (Channel News Asia)
  • Australian Public Assessment Reports for prescription medicines (AusPARs) (TGA)
  • Changes to the therapeutic goods advertising framework (TGA)
  • ACMD meeting statement, Meeting 39, 23 February 2018 (TGA)
  • Australian Public Assessment Report on Novartis’ AusPAR: Ceritinib (TGA)
  • Measles confirmed on Air Canada flight from Zurich to Toronto (The Star)
  • Blame Canada's history for low rates of cancer screening among Indigenous women, doctor says (CBC News)
General Health & Other Interesting Articles
  • More Prison Inmates Get Access to Hepatitis-C Drugs (WSJ)
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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