Regulatory Focus™ > News Articles > 4 > Recon: FDA Re-examines Arcadia Parkinson's Drug, EU Calls for Renewed Push Against Preventable Disea

Recon: FDA Re-examines Arcadia Parkinson's Drug, EU Calls for Renewed Push Against Preventable Diseases

Posted 26 April 2018 | By Ana Mulero 

Recon: FDA Re-examines Arcadia Parkinson's Drug, EU Calls for Renewed Push Against Preventable Diseases

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In Focus: International Pharmaceuticals & Biotechnology
  • How High Drug Prices and Big Lobbying Budgets Go Together for Big Pharma (Fortune-KHN)
  • Feds almost ready to charge drugmakers—and executives—in generics price-fixing probe (Fierce)
  • AbbVie Must Escape the Shadow of Humira's Decline (Bloomberg)
  • Amazon failed to disrupt the prescription drug business with Could a second try succeed? (STAT)
  • You’ve heard about precision medicine. Now get ready for precision drug ads (STAT-$)
  • CRISPR legend Jennifer Doudna helps some recent college grads launch a diagnostics upstart (Endpoints)
  • The Drug Supply Chain Security Act: A progress report (BioPharma Dive)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Roche flags first case of anti-drug antibodies that forced a patient to drop would-be blockbuster Hemlibra (Endpoints)
  • GSK tips its hat on new deals, reviews incentives as Hal Barron cooks up a turnaround plan for its lackluster R&D group (Endpoints)
  • Celgene’s disclosures about ozanimod this week spur analysts’ fears of a lengthy delay for a key drug (Endpoints)
  • Neurocrine presents positive analysis of Phase III Ingrezza data (The Pharma Letter)
  • AllTrials audit finds most top public funders lack research transparency policies (Fierce)
  • Alder builds case for CGRP migraine drug eptinezumab (FIerce)
  • Saniona cleared for second phase of Prader-Willi syndrome trial (Fierce)
  • FDA could convene second advisory panel to re-examine safety of Acadia Pharma drug (STAT-$)
  • What's the Total Cost of One CAR T-Cell Treatment? (Medscape)
  • Astellas files experimental AML therapy (PharmaTimes)
Medical Devices
  • Fresenius Medical Care North America Launches Corporate Charitable Foundation (Press)
  • Medineering touts first uses of Robotic Endoscopy system (MassDevice)
  • Restech acquires Mederi Medical (MassDevice)
  • Agfa Receives FDA 510(k) Clearance for DR 800 Multi-purpose Digital Imaging System (Press)
  • Mobius Imaging Receives 510(k) Clearance for Airo CT Pediatric Applications (Press)
  • Medical Device Startup Blink Device Company Announces 510(k) Clearance of TwitchView Quantitative Monitor for Neuromuscular Blockade and Hires VP of Sales and Marketing (Press)
US: Assorted & Government
  • Trauma centers serving vulnerable patients on shaky financial ground (Reuters)
  • Judge rules in Baltimore's favor in suit over federal cuts to teen pregnancy prevention program (The Baltimore Sun)
  • 31 more sick in romaine lettuce E. coli outbreak (USA Today)
  • Will Amazon Bend the Cost Curve for Health Care? (Bloomberg)
  • The Trump Administration Wants to Take the Mystery Out of How Much Hospitals Charge Patients (Fortune)
Upcoming Meetings & Events Europe
  • BD Vacutainer EDTA & BD Vacutainer Lithium Heparin Tubes – risk of incorrect results for lead testing or other assays using ASV methodology (MHRA)
  • Couple sentenced for operating fake online pharmacy (MHRA)
  • German minister calls for clearer labeling of unhealthy food (Reuters)
  • ABPI explores the future of medicines (PMLiVE)
  • Pfizer takes aim at UK’s health tech industry (PMLiVE)
  • Lords slam government commitment to life sciences strategy (PharmaTimes)
  • U.K. Healthcare Startup Said to Have Posted Fake Reviews Online (Bloomberg)
  • EU Invests Funds, Working On Standards To Spur AI Growth (Law360-$)
  • Taiwan accuses China of risk to global health over WHO ban (The Straits Times)
  • Twice rejected by Lilly, Adocia mounts recovery with diabetes drug deal (Fierce)
  • Amitabh Bachchan: 'Forget the Avengers, it took real heroes to make India polio-free' (The Guardian)
  • TGA stakeholder survey 2017 (TGA)
  • Prostate cancer: early detection saves lives (The Australian)
  • What We Heard - Proposals for prescription drug transparency (Health Canada)
General Health & Other Interesting Articles
  • Income, education tied to physical function in old age (Reuters)
  • A startup promised to make health care ‘refreshingly simple.’ Building the business has been anything but (STAT)
  • Commentary: Shame won't help opioid addicts (Chicago Tribune)
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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