Regulatory Focus™ > News Articles > Regulatory Recon: House Bill Would Add Zika to FDA Priority Review Voucher Program (2 February 2016)

Regulatory Recon: House Bill Would Add Zika to FDA Priority Review Voucher Program (2 February 2016)

Posted 02 February 2016 | By Michael Mezher 

Regulatory Recon: House Bill Would Add Zika to FDA Priority Review Voucher Program (2 February 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Undisclosed Conflicts Common Among FDA Hearing Speakers (Medpage Today) (EurekAlert) (JAMA)
  • The Real Reason Medicare Is a Lousy Drug Negotiator: It Can't Say No (NYTimes)
  • Modernizing Pharmaceutical Manufacturing to Improve Drug Quality: Ensuring a Safe and Adequate Supply of Drugs (FDA Voice) (Focus)
  • Reforming Federal Oversight Of Medical Devices Won't Be Easy (KHN) (MedCityNews)
  • Shkreli Was Right: Everyone's Hiking Drug Prices (Bloomberg)
  • House Bill Would Add Zika to Tropical Disease Priority Voucher Program(Bill) (Press Release)

In Focus: International

  • WHO Declares Public Health Emergency Over Microcephaly, Zika Suspected as Cause (Focus) (Reuters) (NYTimes)
  • EMA: Framework for Interaction with Industry (Policy and Medicine) (Focus)
  • The Future of Eudamed – Better, Bigger, Riskier (Emergo)
  • African Union Heads of State make a major policy decision to improve medicines regulation (PharmaAfrica)
  • Sanofi launches hunt for Zika vaccine as disease fears grow (Reuters) (SCRIP-$)
  • 'Clear statistical reservations' surround Bial's fatal clinical trial (In-PharmaTechnologist)
  • Building research and development on poverty-related diseases (WHO Bulletin)

US: Pharmaceuticals and Biotechnology

  • Therapy focus – Multiple myeloma pricing set to feel the heat (EP Vantage)
  • Billion-Dollar Cancer 'Moonshot' Plan Includes $75M in New Funds for FDA (Focus) (Reuters) (NYTimes)
  • Brintellix Review To Focus On Cognitive Function Measurement (Pink Sheet-$)
  • CDC Endorses A More Effective HPV Vaccine To Prevent Cancer (NPR)
  • CVS to make overdose drug naloxone prescription-free in Ohio (Reuters)
  • Modest Price Cut Expected For Generic Version Of Cancer Pill Gleevec (NPR)
  • Microbioreactor could replace animal testing (BioPharma-Reporter)
  • Scientists create imaging 'toolkit' to help identify new brain tumor drug targets (EurekAlert)
  • Risk of opioid overdose 'influenced by prescription strength' (MNT)
  • More link think? OPDP lists social media links as guidance item for 2016 (FiercePharmaMarketing)

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

  • Reneuron gets US patent for non-toxic cell cryopreservation system (BioPharma-Reporter)
  • CEL-SCI Reports Monthly Patient Enrollment in January for Its Phase 3 Head and Neck Cancer Trial (Press)
  • Ziarco Pharma Ltd - Phase 2a Psoriasis Study Initiated with Ziarco's Lead Compound ZPL-389 (Press)
  • Impax Receives Tentative FDA Approval for Generic Version of Vytorin (ezetimibe and simvastatin) Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg (Press)
  • Teligent, Inc. Announces FDA Approval Of Lidocaine Ointment USP 5% (Press)
  • Bracco Diagnostics Inc. Receives First US FDA Approval For Barium-Based Product Used For Contrast Radiography (Press)
  • NDA Submitted for Chronic Idiopathic Constipation Drug Plecanatide (MPR)
  • Lion Biotechnologies Announces Allowance of IND Application to Begin Clinical Trials in Cervical, Head and Neck Cancers (CNN Money)
  • Results from Phase 3 trial of defibrotide for the treatment of severe veno-occlusive disease and multi-organ failure published (MNT)

US: Medical Devices

  • Information about Automated Endoscope Reprocessors (AERs) and FDA's Evaluation (FDA)
  • FDA Mammography Quality Standards Act National Statistics (FDA)
  • Insurer's Approval Of Genetic Testing For Some Cancers Raises Questions (KHN)
  • Biocompatibility Safety Assessment of Medical Devices: FDA, ISO, and Japanese Guidelines (MDDI)
  • Study Closure and Final Sponsor Report (Medical Device CRO Blog)
  • Blood Test Offers An Amazing View Of Metastatic Prostate Cancer Cells (Forbes)
  • BIOTRONIK MRI-Compatible Ilivia ICDs and CRT-Ds with MRI AutoDetect Approved in Europe (medGadget)
  • LivaNova wins FDA nod for Crown PRT stented heart valve (MassDevice)

US: Assorted and Government

  • What The Court Got Wrong About Hatch-Waxman In Alcon (Law360-$)
  • U.S. appeals court ruling may clear barrier to generic OxyContin (Reuters)
  • 6 ways to reduce the price you pay for prescription drugs (Washington Post)
  • Will Amarin Case Put Judges in Charge of Drug Promotion? (Medpage Today)
  • The Peculiar Brilliance Of Donald Trump's Healthcare Strategy (Forbes)
  • This is the best way to end soaring drug prices (Washington Post)
  • Medicaid Rebate Final Rule Published in Federal Register, HP&M Issues Summary, Schedules Webinar (FDA Law Blog)
  • Velano Vascular's New Needle-Free Blood Draw Device FDA Cleared (medGadget)

Upcoming Meetings and Events              

Europe

  • EMA Offers New Draft Guidance on Developing Alzheimer's Treatments (Focus)
  • Scottish government announces review of how medicines are assessed for NHS use (Pharmaceutical Journal-$)
  • Sanofi Tells Unions Drugmaker Plans to Cut 600 Jobs in France (Bloomberg)
  • Medtronic Adds New Resolute Onyx(TM) Drug-Eluting Stent Sizes and Expands Indications (Press) (MassDevice)
  • ICH guideline E14: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for nonantiarrhythmic drugs (R3) - questions and answers (EMA)
  • ICH guideline E18 on genomic sampling and management 5 of genomic data (EMA)
  • Draft Guideline on core SmPC and Package Leaflet for nanocolloidal technetium (99m Tc) albumin (EMA)
  • Cancer patient organisation: A cancer diagnosis is no longer a death sentence (EurActiv)
  • Mylan Generics In Europe: Three Positive Opinions, One Filing Withdrawn (SCRIP-$)
  • Gilead Files Truvada For HIV Pre-Exposure Prophylaxis (SCRIP-$)
  • French Industry Head Lauds New Drug Pricing Deal (SCRIP-$)
  • NICE widens access to ankylosing spondylitis therapy(PharmaTimes)

India                                                            

  • USFDA inspects two units of Aurobindo Pharma; makes observations (Economic Times)
  • Dr Reddy's goes beyond generic products, gets nod for two branded drugs (Economic Times)
  • India Targets Illicit Sex-Selective Abortions (WSJ-$)
  • Aurobindo gets USFDA nod for epilepsy, arthritis drugs (Economic Times)
  • GSK Biologicals Secures Indian Patent for Vaccine to Protect Against S. Pneumoniae (24 Insight)
  • Indian government moves to ease export requirements for pharma companies (PharmaLetter-$)

Japan

  • Daiichi Sankyo to Expand Access to Clinical Trial Data (Press)

Zika Virus

  • CDC director says WHO declaration 'calls world to action' on Zika (Reuters)
  • Zika Is Not the New Ebola (Chatham House)
  • Brazil says Zika virus outbreak worse than believed (Reuters)
  • Brazil authorizes forced entry to private property to fight Zika (Reuters)
  • New York to offer free Zika tests (Reuters)
  • U.S. adds four more countries to Zika travel alert list (Reuters) (CDC)
  • Zika vaccine may be ready for emergency use this year: developer (Reuters)
  • Africa, Asia vulnerable to spread of Zika virus: WHO (Reuters)
  • Australia reports two cases of Zika virus, detects mosquitoes at Sydney airport (Reuters) (NYTimes)
  • Thai health ministry says don't panic over Zika virus (Reuters)
  • Student at College of William & Mary has contracted the Zika virus (Washington Post)

Other International

  • Health workers sent to north Uganda as malaria epidemic kills over 650 (Reuters)
  • Mortality from neglected tropical diseases in Brazil, 2000–2011 (WHO Bulletin)
  • Indonesia mulls foreign JVs and reduction on imports to boost local API production (In-PharmaTechnologist)

General Health and Other Interesting Articles

  • Why I let a brain tumor go untouched for 10 years (Washington Post)
  • Pursuing the Goal of Healthy Aging (NYTimes)

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 @Michael_Mezher 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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