Regulatory Focus™ > News Articles > Regulatory Recon: Drug Firms Challenge UK Trials Transparency Effort (18 May 2015)

Regulatory Recon: Drug Firms Challenge UK Trials Transparency Effort (18 May 2015)

Posted 18 May 2015 | By

Regulatory Recon: Drug Firms Challenge UK Trials Transparency Effort (18 May 2015)

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

In Focus: US

  • FDA to Hold Meeting on Use, Uptake of Opioid Overdose Reversal Drug Naloxone (FDA)
  • The 21st Century Cures Act And Drug Company Promotion Of Real-World Data (Health Affairs)
  • New York Introduces Pharmaceutical Cost Transparency Bill (Policy and Medicine)
  • REMS Are Not The Right Weapon Against Antibiotic Resistance, FDA Says (Pink Sheet-$)
  • IEEE Cybersecurity Initiative Releases “Building Code for Medical Device Software Security” (Press) (Code)
  • FDA Panel Urges Intensified Device Cleaning to Stave Off ‘Superbugs’ (WSJ-$) (LATimes) (FPN) (MPT)
  • Cybersecurity and the artificial pancreas -- what are the risks? (MNT) (Paper)
  • DMAA Supplements Still on U.S. Market in Spite of FDA Enforcement (NPI)
  • Medical cures bill on the move (The Hill) (BioCentury)

In Focus: International

  • Drug trials firm to challenge plans for greater transparency over results (Guardian)
  • The EU Falsified Medicines Directive: what does pharma need patients to know? (Pharmafile)
  • Indian Health ministry to roll out materio-vigilance programme for safety of medical devices soon (PharmaBiz)
  • Why Does ANVISA Embrace GS1 Standards, Except The Serial Number? (RxTrace)

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US: Pharmaceuticals and Biotechnology

  • FDA to Hold Meeting on Use, Uptake of Opioid Overdose Reversal Drug Naloxone (FDA)
  • The 21st Century Cures Act And Drug Company Promotion Of Real-World Data (Health Affairs)
  • New York Introduces Pharmaceutical Cost Transparency Bill (Policy and Medicine)
  • Vertex’s Orkambi Efficacy Data May Make FDA More Cautious With Other ‘Breakthroughs’ (Pink Sheet-$)
  • Flexibility Or Formal Pathway? Avycaz Suggests FDA Doesn't Need Congress To Expedite Limited Use Antibiotics (Pink Sheet-$)
  • REMS Are Not The Right Weapon Against Antibiotic Resistance, FDA Says (Pink Sheet-$)
  • Reagan-Udall, Pfizer Testing Ways To Tap Sentinel Network Without FDA (Pink Sheet-$) (SCRIP-$)
  • US lawsuit puts generic drug imports from India under scanner (India Times)
  • Failure to Properly Drug List – a New Compliance Target? (Lachman)
  • As in 2014, “right-to-try” laws continue to metastasize in 2015 (Science-Based Medicine)
  • GSK Files New Suit Against Teva Over Generic Wellbutrin (Law 360-$)
  • Simulating Adverse Event Spontaneous Reporting Systems as Preferential Attachment Networks (PMC)
  • Novel Algorithms for Improved Pattern Recognition Using the US FDA Adverse Event Network Analyzer (IOS Press)
  • NYTimes Editorial Board: FDA, Congress Need to Look Into How to Help Rein in Bogus Drugs (NYTimes)
  • From our perspective: The U.S. drug supply chain and patient safety (FDA)
  • Baxter Receives U.S. FDA Approval for 0.9% Sodium Chloride Injection (Press)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Late-stage data back Orkambi benefit in cystic fibrosis (PharmaTimes) (Press)
  • Third Rock's Eleven Bio flunks a Phase III dry eye study (Fierce)
  • Xtandi benefit larger in certain TNBC patients (BioCentury)
  • New data and analyses confirm the efficacy and safety of Boehringer's OFEV (nintedanib) for the treatment of IPF beyond 52 weeks and for distinct subgroups (Press)
  • FDA Fast Track Designation Granted to Luspatercept for the Treatment of Patients with Beta-Thalassemia (Fierce)
  • Agios Announces FDA Fast Track Designation Granted to AG-120 for Treatment of Patients with Acute Myelogenous Leukemia with an IDH1 Mutation (Fierce)
  • Karyopharm reports Phase II selinexor data (BioCentury)
  • Humira Designated Orphan Drug for Painful, Inflammatory Skin Disease (MPR) (Press)

US: Pharmaceuticals and Biotechnology: General

  • Fixing failed emerging threat R&D model: Is the US way best? (SCRIP-$)
  • The debate over prescription painkillers, explained (Vox)

US: Medical Devices

  • IEEE Cybersecurity Initiative Releases “Building Code for Medical Device Software Security” (Press) (Code)
  • FDA Panel Urges Intensified Device Cleaning to Stave Off ‘Superbugs’ (WSJ-$) (LATimes) (FPN) (MPT)
  • Cybersecurity and the artificial pancreas -- what are the risks? (MNT) (Paper)
  • Rep. Burgess Still Wants to Limit FDA LDT Oversight (Gray Sheet-$)
  • HRS 2015: Biotronik’s Iforia ICD safe for MRI (MassDevice)
  • Veracyte lung cancer test could help avoid some risky biopsies (Reuters)

US: Dietary Supplements

  • DMAA Supplements Still on U.S. Market in Spite of FDA Enforcement (NPI)
  • FTC Returns $3 Million to Consumers in Cactus Juice Scam (FTC)

US: Assorted And Government

  • Medical cures bill on the move (The Hill) (BioCentury)
  • New Federal Website Makes FOIA Requests Easier To Understand, But Still Can't Make Them – Yet (HuffPo)
  • Brookings: Draft 21st Century Cures Act a "step backwards from transparency" (Brookings)
  • Ongoing 'Cures' Negotiations On FDA Funding (Politico)
  • PWC's Weekly Regulatory Newsletter (PWC)
  • House seeks momentum on medical cures (The Hill)

Upcoming Meetings and Events

Europe

  • Drug trials firm to challenge plans for greater transparency over results (Guardian)
  • The EU Falsified Medicines Directive: what does pharma need patients to know? (Pharmafile)
  • Europe wants scientific advice to become pluralistic (PMLive)
  • EFPIA and CPIA Joint Forum to Enhance Regulatory Understanding (EFPIA)
  • NGOs launch watchdog to keep an eye on the Commission's 'Better Regulation' (EurActiv)

India

  • Indian Health ministry to roll out materio-vigilance programme for safety of medical devices soon (PharmaBiz)
  • Weekly Recap – Supreme Court Action, SEC and Apex Committee Meetings, D&C Bill To Be Introduced (Two-Four Insight)

Other International

  • Cheap blindness drug should be made widely available, says WHO (Guardian)
  • Why Does ANVISA Embrace GS1 Standards, Except The Serial Number? (RxTrace)

General Regulatory And Interesting Articles

  • David Sackett, the father of evidence-based medicine, dies at 80 (Vox)

Regulatory Reconnaissance #559 – 18 May 2015

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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