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

• Cancer Panel Calls for Measures to Lower Drug Costs (WSJ) (Report)
• Patient death forces FDA to slap a hold on study using combo from Advaxis, AstraZeneca — biotech’s shares plunge (Endpoints News) (Reuters) (PharmaTimes) (Fierce) (Biopharma Dive)
• Halted in US by FDA hold, Bellicum buoyed by some positive numbers from its European T cell study for pediatric AML (Endpoints News) (Fierce)
• Ex-GlaxoSmithKline CEO to lead UnitedHealth's Optum (Minneapolis/St. Pail Business Journal) (Fierce) (Endpoints News) (Reuters)
• Stretching Accelerated Approval: Why FDA Wants to Make Overall Survival an Endpoint for Accelerated Approval (BioCentury)
• Cures Welcome at FDA (WSJ)
• CVS, Aetna shareholders approve drugstore's acquisition of health insurer (CNBC) (Reuters)
• US FDA to probe drug ads to evaluate need for more targeted risk disclosures (S&P Global) (Focus)
• Teva hands back rights to preclinical CGRP blocker (Biopharma Dive) (pharmaphorum) (Endpoints News)

• 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)

• 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)

• 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-$)

• 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)

• 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)

• FDA Advisory Committee Calendar
• Reauthorization of Animal Drug User Fees 2018: ADUFA and AGDUFA
• Perspectives on the 340B Drug Pricing Program

• 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)

• More Prison Inmates Get Access to Hepatitis-C Drugs (WSJ)