Regulatory Focus™ > News Articles > Regulatory Recon: The Struggle to Test Drugs and Vaccines to Treat the Ebola Virus (10 April 2015)

Regulatory Recon: The Struggle to Test Drugs and Vaccines to Treat the Ebola Virus (10 April 2015)

Posted 10 April 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: The Struggle to Test Drugs and Vaccines to Treat the Ebola Virus (10 April 2015)

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

In Focus: US

  • What's in a name? For drugs, a lot of Zs and Xs (CNBC)
  • Drug regulations tied to fewer prescriptions of effective gout drug (MNT)
  • Study: Off-Label Drug Prescribing Doesn't Necessarily Cause More Adverse Events (PubMed)
  • An Update on Pending Hatch-Waxman and BPCIA Litigation (FDA Law Blog)
  • Roche gets FDA clearance, brief recall for diabetes management app (MobiHealthNews)
  • Retailers to Stop Sales of Controversial Supplements (NYTimes)
  • US officials pound drum harder in trade agenda pursuit (SCRIP-$)

In Focus: International

  • Squabbles Over Testing Methods Hamper Search for Ebola Vaccine (WSJ-$)
  • New EU rules on human tissues and cells increase patient safety (EC) (Directive) (Directive)
  • European Commission Releases Modified Directive on Use of Polyvinyl Chloride in IVDs (Eur-Lex)
  • Indian Task Force on medical devices recommends to formulate 'Medical Device Regulatory Act' (PharmaBiz)
  • Mexico clears Biocon's 'biocomparable' insulin glargine (SCRIP-$)
  • TransCelerate launches two new initiatives to accelerate clinical trials (Outsourcing Pharma)

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US: Pharmaceuticals and Biotechnology

  • What's in a name? For drugs, a lot of Zs and Xs (CNBC)
  • Drug regulations tied to fewer prescriptions of effective gout drug (MNT)
  • Study: Off-Label Drug Prescribing Doesn't Necessarily Cause More Adverse Events (PubMed)
  • An Update on Pending Hatch-Waxman and BPCIA Litigation (FDA Law Blog)
  • AZ's Onglyza has most to lose at FDA safety confab, analysts say (Fierce) (MM&M)
  • Texas Senate OKs Right to Try Bill (ABC13)
  • California Right to Try Bill Advances (Scout)
  • Some Declaratory Judgment Guidance For ANDA Litigants (Law 360-$)
  • The FDA’s Focus on Data Integrity: The Whole Story (FDAzilla)
  • Should Biogen investors worry about new PML case? (SCRIP-$)
  • Where Are The ‘Five Stars’ Merck Got From Schering-Plough? (Pharmalot)

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

  • US priority review for Shire's dry eye drug, lifitegrast (PharmaTimes) (Fierce) (SCRIP-$) (Press) (BioCentury)
  • One of Shire's top blockbuster drug prospects flops in a key PhII study (Fierce) (SCRIP-$)
  • Exelixis’ Cabozantinib Granted Fast Track Designation by FDA For Advanced Renal Cell Carcinoma (Press)
  • Horizon Pharma’s Friedreich’s Ataxia Drug Gets Fast-Track Designation (WSJ-$)

US: Pharmaceuticals and Biotechnology: General

  • Gilead’s $1,000 Pill Is Hard for States to Swallow (WSJ-$)
  • Vermont governor demands price cut for Amphastar's overdose antidote (Fierce)
  • No Easy Answers for Rise in Drug Prices (MedPage Today)

US: Medical Devices

  • Roche gets FDA clearance, brief recall for diabetes management app (MobiHealthNews)
  • Arizona law allows consumers to order lab tests directly (BioCentury)
  • FDA clears Mayo Clinic spin-off’s decision support software (MobiHealthNews-$)
  • ivWatch Receives FDA Clearance and Significantly Advances Safety of IV Therapy (Press)
  • How to run effective medical device design reviews (MedCityNews)
  • NIH funds nine antimicrobial resistance diagnostics projects (NIH)

US: Dietary Supplements

  • Retailers to Stop Sales of Controversial Supplements (NYTimes)
  • GNC responds to industry questions about its NY AG deal with open letter from CEO (NI-USA)
  • Recent enforcement trends: state attorneys general target the dietary supplements industry (NI-USA)
  • FDA Figures It Will Get Around To Regulating Supplements With Names Like Black Widow, Yellow Demon (The Onion-Satire)

US: Assorted And Government

  • Navigating the Landscape of Patient Registries (FasterCures)
  • FTC Approves Final Order Barring Company from Making Unsubstantiated Claims Related to Products’ “Brain Training” Capabilities (FTC) (NI-USA)
  • US officials pound drum harder in trade agenda pursuit (SCRIP-$)

Upcoming Meetings and Events

Ebola Outbreak

  • Squabbles Over Testing Methods Hamper Search for Ebola Vaccine (WSJ-$)
  • Aethlon Medical eyes full marketing approval for Ebola biofiltration device (Fierce)
  • Right Job, Wrong Tool: A Commentary on Designing Clinical Trials for Ebola Virus Disease (Bioethics-$)
  • FDA Orders Recall of Uncleared/Unapproved Ebola Device (FDA)
  • Controlling Ebola Trials (BioEthics-$)
  • Most Recent Issue of the American Journal of Bioethics Entirely Focused on Ebola (Bioethics)

Europe

  • New EU rules on human tissues and cells increase patient safety (EC) (Directive) (Directive)
  • European Commission Releases Modified Directive on Use of Polyvinyl Chloride in IVDs (Eur-Lex)
  • 50 Years of Pharma Legislation Has Been Beneficial, but Europe Needs to Keep Its Foot on the Gas (EFPIA)
  • Alexion Receives Approval for Important Updates to the European Label for Soliris (eculizumab) (Press)
  • More arrests in Italian pharma theft clampdown (Securing Industry)
  • Sophia Genetics Gets CE-IVD Mark for Solution to Detect CNVs in BRCA1/2 (GenomeWeb)
  • Russia’s General Prosecutor Office to force producers to reduce prices for vital drugs (PharmaLetter-$)
  • IQWiG passes Boehringer lung cancer drug (PMLive)

India

  • Task Force on medical devices recommends to formulate 'Medical Device Regulatory Act' (PharmaBiz)
  • India drug price chief sacked as essential drug prices rise (Fierce)

Canada

  • Expired Pfizer contraceptives recalled after supply chain fumble (Fierce)

Australia

  • New guidance addresses Australian firms' worries over post-market reviews (SCRIP RA-$)

Other International

  • Mexico clears Biocon's 'biocomparable' insulin glargine (SCRIP-$)
  • What is needed to accelerate access to quality medicines and vaccines in Africa? (PharmaLetter-$)

Clinical Trials

  • TransCelerate launches two new initiatives to accelerate clinical trials (Outsourcing Pharma)
  • Experts Call For More Clinical Trials Of Percutaneous Circulatory Devices (Gray Sheet-$)

General Regulatory And Interesting Articles

  • Diabetes devices may interfere with avalanche beacon signals (Reuters)
  • Fighting fake drugs about patient safety not competitive advantage says Rx-360 (In-Pharma)

Regulatory Reconnaissance #533 – 10 April 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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