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

Posted 21 June 2018 | By Ana Mulero 

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

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

In Focus: US
  • 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)
In Focus: International
  • 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-$)
  • What's Holding Back Market Uptake Of Biosimilars? (Forbes)
  • Drug prices row: EU health chief hits back at Trump view that Europe is ‘free-loading’ on US innovation (Science Business)
  • Draft South African Law Sets Stage for National Health Insurance (Bloomberg)
  • WHO opens new Country Office in Greece (WHO)
  • India's per capita expenditure on healthcare among lowest in the world; govt spends as little as Rs 3 per day on each citizen (FirstPost) (Business Standard)
  • Superbugs: MEPs advocate further measures to curb use of antimicrobials (European Parliament)
  • Behind Atul Gawande’s rise is the incredible story of his Indian immigrant parents (Quartz India)
Pharmaceuticals & Biotechnology
  • A quest to drug the undruggable (C&EN)
  • Wanted: Wrinkled Men Not Afraid of Needles for ‘Brotox’ Revival (Bloomberg)
  • Steven Cohen Keeps Buying Acadia Pharmaceuticals, A Stock Down By Half This Year (Forbes)
  • Number of drug makers lobbying Congress on pricing issues skyrockets (STAT-$)
  • 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)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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)
Asia
  • 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)
India
  • 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)
Australia
  • iX Biopharma receives Australian regulatory approval for Wafesil to treat male erectile dysfunction (Pharmabiz)
  • Electronic submissions (TGA)
Canada
  • 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)
General Health & Other Interesting Articles
  • 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)
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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