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Recon: White House Proposes Taking the Food out of FDA

Posted 22 June 2018 | By Ana Mulero 

Recon: White House Proposes Taking the Food out of FDA

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

In Focus: US In Focus: International Pharmaceuticals & Biotechnology
  • What Is Ailing the Drug Industry? (The Wall Street Journal)
  • Tesaro stock rockets as rumours of Roche takeover abound (pharmaphorum)
  • Opioids don’t have to be addictive – the new versions will treat pain without triggering pleasure (The Conversation)
  • VR Art Reduces Need For Opioids in NY Hospital (Forbes)
  • We need more answers about immunotherapy for the elderly (STAT)
  • ‘Living Legos’ form blood vessels to simulate heart disease and test drugs (STAT-$)
  • Can biotech keep its breathless IPO pace? A look at the numbers (STAT-$)
  • Up and down the ladder: The latest comings and goings (STAT-$)
  • To save money, my insurance company forced me to try drugs that didn’t work (The Verge)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Naturally-Derived Cancer Drugs Provide Clues As To How Microbiome May Cause Chemotherapy Resistance (Forbes)
  • Acurx Pharma's antibiotic product candidate, ACX-362E gets US FDA qualified infectious disease product status (Pharmabiz)
  • Alligator Bioscience presents positive additional preclinical data from ATOR-1017 to treat metastasizing cancer at WPC meeting (Pharmabiz)
  • Harmony Biosciences Makes Headway on Narcolepsy Drug Involving Histamine (BioSpace)
  • Impel NeuroPharma Announces FDA Clearance of IND for Pivotal Phase 3 Study of INP104 for Acute Treatment of Migraine (Press)
  • Adamas Presents New Data Analysis Demonstrating that GOCOVRI Reduces Transitions between Dyskinesia and OFF Episodes Throughout the Day (Press)
  • Optinose Announces Publication of Pivotal Efficacy and Long-Term Safety Data for XHANCE in Peer Reviewed Journals (Press)
Medical Devices
  • Nerve stimulation device maker electroCore goes public with $78M IPO (Fierce)
  • Smith & Nephew Wants Hip MDL Slashed Over Time Bar (Law360-$)
  • GPB Capital puts $21m into CardioFocus for HeartLight catheter launch (MassDevice)
  • No new trial for Bard in $4m vena cava filter loss (MassDevice)
  • Purdue University researchers develop glucose-monitoring contact lens (MobiHealthNews)
  • Masimo, Thermomedics team up to launch Bluetooth, contactless thermometer (MobiHealthNews)
  • Abbott Receives FDA Clearance for Afinion HbA1c Dx for Diagnosing Diabetes (Press)
  • Tenon Medical, Inc. Receives FDA Clearance For Sacroiliac Joint Fusion System (Press)
  • LUTRONIC Announces U.S. FDA Clearance for 1.8 GW Picosecond Laser (Press)
  • Tandem Diabetes Care Announces FDA Approval of t:slim X2 Insulin Pump with Basal-IQ Technology (Press)
  • Siemens Healthineers launches Acuson Sequoia to address industry challenges in ultrasound imaging (Press)
US: Assorted & Government
  • How Trump's ACA case differs from Obama's (Axios)
  • Allscripts offering buyouts (Politico)
  • FDA mustn't interfere with dying patients' right to experimental treatments (Washington Examiner)
  • CVS Health CEO Larry Merlo: Confident Aetna deal will close later this year (CNBC)
  • Lyft Is Offering Free Rides to Cancer Patients in Major U.S. Cities (Fortune)
  • Head of new U.S. corporate health plan cites surgery as biggest cost (Reuters)
  • FDA shouldn’t allow politics to hurt women suffering miscarriage (STAT)
  • How life sciences companies are using AI — and how to separate hope from hype (STAT-$)
  • Trump Administration Resumes Approving Young Doctor Visas (Forbes)
  • Sanofi Judge Skeptical She Was Wrong To Toss Antitrust Suit (Law360-$)
  • PBMs, Insurers Back Anthem, Express Scripts In Pricing Suit (Law360-$)
Upcoming Meetings & Events Europe
  • Ireland urgently needs access to new drugs, says pharma body (Irish Times)
  • How much does big pharma make from animal antibiotics? (The Guardian)
  • Pharma expert: Combination vaccines reduce the cost of outbreaks and treatments (EURACTIV)
  • Industry urges EU to scrap national HTA bodies (pharmaphorum)
  • Brexit and the medical devices industry: coping with uncertainty (Lexology-$)
  • Stada Arz recovers selling rights to Parkinson's drug (The Pharma Letter)
  • Impersonation of MHRA staff (MHRA)
  • LumiThera LT-300 Device For Treating Dry Advanced Macular Degeneration Granted CE Mark (Press)
Asia
  • Israel's UroGen to start mid-stage bladder cancer trial (Reuters)
  • Korean pharmaceuticals enter schizophrenia therapy market (Korea Biomedical Review)
  • ‘Long-term aspirin use can lower gastric cancer risks’ (Korea Biomedical Review)
  • Jiao Hong,CNDA Commissioner meets UNAIDS Executive Director Michel Sidibe (CFDA)
India
  • Government may scrap trials for some IVD devices (Livemint)
  • APAC Biotech and Diakonos collaborate on immunotherapy technology for India (The Pharma Letter) (Press)
  • Astrazeneca Pharma sweetens after securing permission (Business Standard)
Australia
  • Three babies and young adult given donor tissue from cancer patient (The Guardian)
  • Inaugural Industry Forum on Good Manufacturing Practice (GMP) (TGA)
  • Metronidazole intravenous infusion 500 mg/100 mL bag (TGA)
Canada
  • Proposed Amendments to Regulations Define Health Care Institutions’ Pharmaceutical and Medical Device Adverse Event Reporting Obligations (Lexology-$)
  • List of Drugs for an Urgent Public Health Need (Health Canada)
General Health & Other Interesting Articles
  • Many psychiatric conditions have the same genes in common (New Scientist)
  • Researchers Just Printed Sensors Onto Gummi Candies (Forbes)
  • Lifestyle changes can help obese women improve fertility (Reuters)
  • Targeting cancer cells' escape vehicles to stop tumor metastasis (Fierce)
  • Will launching plants into orbit yield new medicines? (STAT)
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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