Regulatory Focus™ > News Articles > Regulatory Recon: Trials May Not Show if Ebola Drugs are Safe or Effective (12 May 2015)

Regulatory Recon: Trials May Not Show if Ebola Drugs are Safe or Effective (12 May 2015)

Posted 12 May 2015 | By Alexander Gaffney, RAC

Regulatory Recon: Trials May Not Show if Ebola Drugs are Safe or Effective (12 May 2015)

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

In Focus: US

  • FDA Weighs in on Important Question: What's a New Drug? (FDA Law Blog)
  • J&J, Endo, Teva and Actavis off the hook in Chicago painkiller lawsuit (Fierce) (Pharmalot) (Law 360-$)
  • Why the newest sunscreens still haven’t hit the U.S. market (WashPo)
  • Why Massachusett's price transparency bill could succeed where others have failed (BioCentury-$)
  • 21st Century Cures: Data Reliance Provision May Raise Exclusivity Issues (Pink Sheet-$)
  • Industry Eager to Help FDA Train Staff (MDDI)
  • Congressman Faults FDA’s Response To Calif. Superbug Outbreak (LATimes)
  • Shuren: LDT Reliability Critical To Precision Medicine Initiative (Gray Sheet-$)
  • FDA Starts Developer Challenge to Tap Into its Public Data (FDA)

In Focus: International

  • As Ebola disappears, no useful data seen from vaccine trials: WHO (Reuters)
  • EMA to screen medical literature for 400 active substance groups (EMA) (EMA)
  • Scottish cost regulators OK NHS use of 7 new drugs (PharmaTimes)
  • EMA: clinical data may not be needed for topical comparisons (In-Pharma)
  • India's Punjab state goes its own way on drug price caps (Fierce) (India Times)
  • Experts call for global research fund for antibiotics, Ebola and other neglected diseases (Guardian) (Press) (PLoS)

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US: Pharmaceuticals and Biotechnology

  • FDA Weighs in on Important Question: What's a New Drug? (FDA Law Blog)
  • J&J, Endo, Teva and Actavis off the hook in Chicago painkiller lawsuit (Fierce) (Pharmalot) (Law 360-$)
  • Why the newest sunscreens still haven’t hit the U.S. market (WashPo)
  • Why Massachusett's price transparency bill could succeed where others have failed (BioCentury-$)
  • HHS: Actavis could cost the government $6B with Namenda hard switch (Fierce) (Law 360-$)
  • 21st Century Cures: Data Reliance Provision May Raise Exclusivity Issues (Pink Sheet-$)
  • FDA Issues Form 483 to Impax over Hayward, CA Facility (Press)
  • FDA Facing Daunting Task of Vetting More Complex Carve-Out of “Protected” Labeling – Is this the New Evergreening? (Lachman)
  • Rare Disease Groups Launch Push for OPEN ACT in 21st Century Cures Act (RDLA)
  • FDA Issues Final Guidance on Veterinary Drug Genotoxicity Testing (FDA) (FR)
  • Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System; Draft Guidance (FDA) (FR)
  • FDA to Hold Meeting on “Dose Finding of Small Molecule Oncology Drugs" (FDA)
  • ‘Pay-For-Delay’ Deals Likely Put On Hold Themselves After Cipro Ruling (Pink Sheet-$)
  • Registering as an outsourcing facility helps rid compounding safety stigma, Fagron (Outsourcing Pharma)
  • FDA Posts Proposed Strategy to Test Donated Blood for Babesia Microti (Tarius)
  • PhRMA Hosting "Next Generation Cures" Event (Webcast Here)

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

  • NewLink's Pancreatic Cancer Vaccine on Long Road to Study Failure (The Street) (BioCentury)
  • FDA Grants Priority Review Status for Novocure’s PMA Supplement Application of Optune in Newly Diagnosed Glioblastoma (Press) (Fierce)
  • U.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label for INVEGA SUSTENNA (Press)
  • Merck KGaA, Darmstadt, Germany, Receives FDA Fast Track Designation for Evofosfamide for the Treatment of Patients Living With Advanced Pancreatic Cancer (Press)
  • New data demonstrates Saxenda (liraglutide 3 mg) provides benefits beyond weight loss (EPR)

US: Pharmaceuticals and Biotechnology: General

  • Politico Launches New Prescription Drug Policy Tipsheet (Politico)
  • Cuba Has a Lung Cancer Vaccine—And America Wants It (Wired)
  • Companies plead guilty to illegally sourcing, distributing pharmaceuticals in US (Outsourcing Pharma) (Fierce)
  • Drug Makers are Having Trouble Improving Their Reputations: Survey (Pharmalot)

US: Medical Devices

  • Industry Eager to Help FDA Train Staff (MDDI)
  • Congressman Faults FDA’s Response To Calif. Superbug Outbreak (LATimes)
  • Shuren: LDT Reliability Critical To Precision Medicine Initiative (Gray Sheet-$)
  • Bayer responds to article critical of its Essure birth control device under FDA investigation (Fierce)
  • FDA Seeks Full-Time Medical Officers to Evaluate Cardiovascular Devices (Posting)

US: Dietary Supplements

  • New York AG, NPA On Same Page For Herbal Ingredients DNA Barcoding (Tan Sheet-$) (NI-USA)
  • Here's Why FDA Is Ordering BMPEA Supplements Off The Market (Forbes)

US: Assorted And Government

  • FDA Starts Developer Challenge to Tap Into its Public Data (FDA)
  • New FDA Guidances for April 2015 (Ask Cato)
  • Source: biopharma didn't refuse 'Cures' pay-for; no one asked (SCRIP-$)
  • House Dems: Repeal medical device tax by Memorial Day (The Hill)
  • A Potential Solution to the Shortage of Solid Organs for Transplantation (JAMA)

Upcoming Meetings and Events

Ebola Outbreak

  • As Ebola disappears, no useful data seen from vaccine trials: WHO (Reuters)

Europe

  • EMA to screen medical literature for 400 active substance groups (EMA) (EMA)
  • Scottish cost regulators OK NHS use of 7 new drugs (PharmaTimes)
  • EMA: clinical data may not be needed for topical comparisons (In-Pharma)
  • An Update on the French Sunshine Law (Policy and Medicine)
  • Workshop on the joint procurement of medical countermeasures (EC)
  • National implementation of EU eSubmission roadmap - information from German BfArM and PEI (Exalon)

India

  • New chapter on the horizon for pharma data exclusivity in India (PharmaLetter-$)
  • India's Punjab state goes its own way on drug price caps (Fierce) (India Times)

Australia

  • TGA Warns About Heartware Ventricular Assist System (TGA)

Other International

  • Experts call for global research fund for antibiotics, Ebola and other neglected diseases (Guardian) (Press) (PLoS)
  • A major AIDS research groups says the TPP will make it harder to fight AIDS (Vox)

General Regulatory And Interesting Articles

  • Drug-resistant 'superbug' strain of typhoid spreads worldwide (Reuters)
  • Prevent Medication Dosing Errors – Ditch the Teaspoon (USP)

Regulatory Reconnaissance #555 – 12 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.


Categories: Recon, Regulatory News

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