Recon: Rising Insulin Prices Spark Outrage; Six Biotechs Raise $568M in IPOs

• Skyrocketing insulin prices provoke new outrage (The Hill)
• The ‘Right to Try’ Could Cost Dying Patients a Fortune (Bloomberg) (Endpoints) (Fierce) (STAT)
• Novo Nordisk’s ‘sema’ whips Merck’s diabetes drug rival in PhIII as it reaches for best-in-class ranking for GLP-1 group (Endpoints) (Reuters) (PBR)
• Controversial researcher’s diabetes vaccine causes improvement in small study (STAT) (Fierce)
• Former Puma Biotech executive gets prison term for insider trading (Reuters) (Endpoints)
• Six IPOs Raising More than a Half-Billion This Week (GEN) (Endpoints) (Fierce)
• Shire bags pediatric label expansion for Cinryze in the US (PharmaTimes) (Fierce)

• Cipla climbs 3% on USFDA approval to HIV drug (Economic Times) (The Hindu Business Line)
• CASI Pharma inks deal for the manufacturing of entecavir and cilostazol (The Pharma Letter-$)
• What's Holding Back Market Uptake Of Biosimilars? (Forbes)
• Drug prices row: EU health chief hits back at Trump view that Europe is ‘free-loading’ on US innovation (Science Business)
• Draft South African Law Sets Stage for National Health Insurance (Bloomberg)
• WHO opens new Country Office in Greece (WHO)
• India's per capita expenditure on healthcare among lowest in the world; govt spends as little as Rs 3 per day on each citizen (FirstPost) (Business Standard)
• Superbugs: MEPs advocate further measures to curb use of antimicrobials (European Parliament)
• Behind Atul Gawande’s rise is the incredible story of his Indian immigrant parents (Quartz India)

• A quest to drug the undruggable (C&EN)
• Wanted: Wrinkled Men Not Afraid of Needles for ‘Brotox’ Revival (Bloomberg)
• Steven Cohen Keeps Buying Acadia Pharmaceuticals, A Stock Down By Half This Year (Forbes)
• Number of drug makers lobbying Congress on pricing issues skyrockets (STAT-$)
• What’s in the House’s bills to address the opioid crisis — and what’s not (STAT)
• Consumer group petitions FDA to yank a widely prescribed gout drug over heart risks (STAT-$)
• Biosimilars for Cancer Emerge as Patents on Widely Used Biological Drugs Expire (NCI)
• Feds Fight Convicted Ex-Valeant Exec's Claims Of Juror Bias (Law360-$)
• GoodRx, a service for finding the best price on prescription drugs, is in sale talks for up to $3 billion (CNBC)
• Addressing Generic-Drug Market Failures — The Case for Establishing a Nonprofit Manufacture (NEJM)
• Great Point Partners, LLC Remains Opposed To The BioCryst Pharmaceutical Proposed Merger With Idera Pharmaceuticals, Inc. (Press)

• More evidence of NSAID risk in early pregnancy (Reuters)
• Mauled by a major setback, Incyte is pointing to a better future — but concedes it also had to scrap another failed study (Endpoints)
• On a winning streak, Heron rockets up 30% on PhIIb pain drug data (Endpoints)
• No Scientific Evidence That Probiotics Improve Anxiety Symptoms In Humans, Finds Study (Forbes)
• New flu vaccine only a little better than traditional shot (AP News)
• Causes of Death After Nonfatal Opioid Overdose (JAMA)
• Novartis Pharmaceuticals Corporation, et al.; Withdrawal of Approval of Five New Drug Applications (FDA)
• HTX-011 for Postoperative Pain Management Receives Breakthrough Therapy Designation from FDA (Press)
• Blueprint Medicines Initiates VOYAGER Phase 3 Clinical Trial of Avapritinib in Patients with Advanced Gastrointestinal Stromal Tumors (Press)

• Lawmakers press genetic testing companies for details on their privacy policies (STAT)
• From smartphone to EHR: a case report on integratingpatient-generated health data (Nature)
• Artificial Intelligence and the Augmentation of Health Care Decision-Making (NEJM)
• Why Walmart filed a patent for blockchain, wearables and EHR data (Healthcare IT News)
• ivWatch to integrate IV infiltration sensor into Philips’ patient monitors (DDBN)
• Abbott escapes payer’s lawsuit over St. Jude Medical CRM batteries (MassDevice)
• 12 Deaths Reported with Weight Loss Gastric Balloons (Drugwatch)
• Bard Can't Get New Trial After $3.6M Vein Filter Verdict (Law360-$)
• Medical Devices; Immunology and Microbiology Devices; Classification of the Next Generation Sequencing Based Tumor Profiling Test (FDA)
• At SNMMI 2018, Siemens Healthineers Announces FDA Clearance of New Molecular Imaging Functionalities (Press)
• Siemens Healthineers Announces FDA Clearance of syngo.via VB30 Molecular Imaging Software (Press)
• UCI, Beckman Coulter Diagnostics announce strategic collaboration (Press)

• Welcome to Right to Try (Science Translational Medicine)
• Trump federal reorganization plan due to arrive this week (Politico)
• Why the VA Needs More Competition (NEJM)
• Trump Officially Nominates a Veterans Affairs Secretary (WSJ)
• The drug pricing war that leaves patients caught in the middle (Axios)
• Everyone is trying to end the opioid epidemic (Axios)
• Health Care Is Eating the Economy. Will Walgreens Sate the Dow? (Bloomberg)
• Oscar to expand individual health insurance to more states (Reuters)
• In Opioid Battle, Cigna Launches New Front To Stop Overdoses (Forbes)
• Salesforce looks to help health insurers be more like the best consumer companies (CNBC)
• FDA Strives to Adapt Regulatory Approach to Rapidly Evolving Digital Health Space (JD Supra)
• The INCLUDE Project Research Plan (NIH)
• A Common Virus May Play Role in Alzheimer’s Disease, Study Finds (NYTimes) (NIH)
• FDA Issues First Installment of Guidance on Intentional Adulteration Rule (FDA Law Blog)
• CMS Launches Data Element Library Supporting Interoperability (CMS)
• Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments (FDA)

• FDA Advisory Committee Calendar

• Even 'resolved' atrial fibrillation carries increased stroke risk (Reuters)
• Executing a medical device rollup strategy, SGH buys 2 companies, doubling in size (Fierce)
• Fat Cell Suppressor Emerges from the Stromal Shadows (GEN)
• Wellcome Trust awards $8bn cash injection to trial schizophrenia drug (pharmaphorum)
• NHS ‘MOTs’ missing attendance, uptake and prescribing targets (PharmaTimes)
• Estar Medical wins patent infringement lawsuit against Regenlab (Pharmabiz)
• Stada Arz recovers selling rights to Parkinson's drug (The Pharma Letter)
• Reva Medical wins CE Mark for full line of Fantom Encore bioresorbable scaffolds (DDBN)
• JenaValve launches CE Mark study of next-gen TAVR system (MassDevice)
• “Have the guts to follow your instincts”: Top CEO Talks About His Time in Biotech and Pharma (Labiotech.eu)
• Interested in joining the Committee for Advanced Therapies (CAT) to represent patients’ associations or clinicians? (EMA)
• Major new funding to attract world's best in science and innovation (UK Government)
• Elekta Unity with Philips MR technology receives CE mark (Press)
• MaaT Pharma and Lutech Sign Licensing Agreement on Microbiome Therapy for Graft-vs-Host Disease (Press)
• Innovus Pharma Receives Approval from Amazon to Expand its Amazon Stores to Europe Covering the United Kingdom, France, Germany, Spain and Italy (Press)

• Walking ability before heart surgery tied to brain function afterward (Reuters)
• Can-Fite delays phase 2 trial of liver cancer drug Namodenoson (PBR)
• GSK Korea’s flu vaccine wins nod for use in infants (Korea Biomedical Review)
• Roche Diagnostics Korea gets reimbursement for EGFR mutation exam (Korea Biomedical Review)
• Shire Korea launches hereditary angioedema therapy Firazyr (Korea Biomedical Review)

• AstraZeneca gets nod to launch cancer drug (The Hindu Business Line)
• Pharmacovigilance guidance document should be made part of D&C Act to ensure 100% compliance of drug industry: Expert (Pharmabiz)
• Maha FDA issues TB notification reporting format for medical labs, hospitals, pharmacies to effectively monitor TB patients (Pharmabiz)
• Massive Insurance Plan In India Will Open New Markets For Medical Devices (Med Device Online)

• iX Biopharma receives Australian regulatory approval for Wafesil to treat male erectile dysfunction (Pharmabiz)
• Electronic submissions (TGA)

• Samsung BioLogics earns first manufacturing approval from Health Canada (The Korea Herald)
• Health Canada plans to ‘severely restrict’ opioid marketing as death toll mounts (Maclean’s)
• Health Canada Licenses Beckman Coulter's Access Sensitive Estradiol Assay (Press)

• Automated Performance Metrics and Machine Learning Algorithms to Measure Surgeon Performance and Anticipate Clinical Outcomes in Robotic Surgery (JAMA)
• AI Hospital Software Knows Who’s Going to Fall (Bloomberg)
• How A Reduction In Hospital Deaths Helped Amazon And Buffett Pick Atul Gawande (Forbes)
• Medical training programs need to care about physician burnout. Should the rest of us? (STAT)
• No-shows at radiology can cost a hospital $1 million a year, study says (Medical Design & Outsourcing)