Regulatory Recon: NEJM Endorses Califf to Head FDA, Japan Fast-Tracks 6 Drugs (29 October 2015)

Posted 29 October 2015 | By Michael Mezher 

Regulatory Recon: NEJM Endorses Califf to Head FDA, Japan Fast-Tracks 6 Drugs (29 October 2015)

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

  • NEJM Endorses Califf to Head FDA (NEJM)
  • US panel proposes executive biodefence office (Nature) (NBC)
  • Express Scripts to maintain availability of AbbVie's hep C drug (Reuters)
  • At top U.S. hospital, almost 50 percent of surgeries have drug-related error (Washington Post)
  • FDA Approves a New Indication for Bristol-Myers Squibb's Yervoy  (BMS) (FDA) (Reuters) (SCRIP-$)
  • Researchers Call for National, International Microbiome Initiatives (GenomeWeb) (NYTimes) (Science) (Nature)
  • The Regulatory Burden Of The Priority Review Voucher Program (Health Affairs Blog)
  • Theranos, Facing Criticism, Says It Has Changed Board Structure (NYTimes)
  • Specialty Pharmacy Linked to Valeant's Sales Tactics Disclosed (WSJ)

In Focus: International

  • Six fast-track drug candidates named by Japan's health ministry (FiercePharmaAsia)
  • You probably have herpes, the WHO says (Reuters) (WHO)
  • Tuberculosis mortality nearly halved since 1990 (Reuters) (WSJ) (WHO)
  • Novartis to close one Indian manufacturing plant as FDA warning bites (FiercePharmaAsia)
  • New Brazilian Medical Device Regulations in Effect (Emergo)

US: Pharmaceuticals and Biotechnology

  • Bringing the Common Rule into the 21st Century (NEJM)
  • FDA Seeks Info on New Tech Helping Conduct Clinical Research (FDA) (Focus)
  • Personalized Medicine: The Challenges Ahead (MedpageToday)
  • Comment Request; Financial Disclosure by Clinical Investigators (FDA)
  • Sanofi US Issues Voluntary Nationwide Recall of Auvi-Q® Due to Potential Inaccurate Dosage Delivery (Reuters) (Sanofi) (FDA)
  • Oncologist Discusses Advancements In Treatment And The Ongoing War On Cancer (NPR)
  • Gilead: Three HIV Launches Expected In Near-Term Future (Pink Sheet-$)
  • FDA Publishes Interim Guidance on Compounding Using Bulk Drug Substances and Once Again Establishes a Time Period for Comments and Nominations (FDA Law Blog)
  • Gene Therapy Could Treat Debilitating Form Of Muscular Dystrophy (Forbes)

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

  • Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for Treatment of All Six Genotypes of Hepatitis C (Press)
  • No difference in efficacy or immunogenicity following switch to Remsima (infliximab) from originator (MNT)
  • New Macrolide Passes Phase III Pneumonia Test (MedpageToday)
  • Astellas Initiates Phase 3 Registration Trial of gilteritinib (ASP2215) in Relapsed or Refractory Acute Myeloid Leukemia Patients (Press)
  • Boehringer Ingelheim’s Biosimilar Candidate Demonstrated Pharmacokinetic Bioequivalence to Adalimumab (Press)
  • Intercept's much-hyped NASH drug misses the mark in Phase II (FierceBiotech) (Intercept)
  • Cannabis Derivative Sativex 'Shows Promise In US Patients' Despite Further Phase III Failure (SCRIP-$)
  • Strategic Science and Technologies Initiates Phase 2 Study to Evaluate Topical Sildenafil in Women with Female Sexual Arousal Disorder (Press)

US: Medical Devices

  • FDA Shoots For New 510(k) Modification Draft Guidance In 2016 (Gray Sheet-$)
  • Valeant's ambitious plan for its contact lens business (Reuters)
  • Rapid diagnostic tests for infections essential in battle against antimicrobial resistance (Pharmaceutical Journal)
  • Next-gen pacemakers may be powered by unlikely source: the heart (Press)
  • Paper-based test could diagnose hepatitis B and assess male fertility at low cost (MNT)
  • Drug-device combination opens potential new path to treat stroke (MNT)
  • Mauna Kea wins FDA 510(k) for Cellvizio (MassDevice)
  • ER-REBOA Catheter for Emergency Occlusion of Aorta FDA Cleared (medGadget)
  • Medtronic touts study of accuracy, cost effectiveness of capnography monitors (MassDevice)

US: Assorted and Government

  • Most Americans want Washington to lower prescription drug prices (Pharmalot)
  • Abbott, AbbVie Urge No Punitive Damages In Depakote Suit (Law360-$)
  • Pfizer and Allergan Begin Merger Talks (WSJ)
  • Gillibrand, Warren Introduce the Cody Miller Patient Medication Information Act (Warren)
  • Pennsylvania Supreme Court reverses Zimmer win in $20m knee implant lawsuit (MassDevice)
  • Signatures to be filed for California drug price referendum (Reuters)

Upcoming Meetings and Events              


  • EU Guideline On Validating, Assessing Device Trials Overhauled (Clinica-$)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 October 2015 (EMA)
  • German Pilot Seeks Companies To Test EU's Future Clinical Trial Application Procedure (SCRIP-$)
  • NICE recommends against Celgene’s drug for pancreatic cancer (PharmaLetter-$)
  • EU vs US: Which Medtech Launch Market Offers Best Returns? (Clinica-$)
  • NICE recommends tolvaptan for patients with ADPKD (EPR)


  • How much transparency does Canada’s new law allow? (AllTrials)


  • Sun Pharma recalls over 10 lakh boxes of allergy drug in US (Economic Times)


  • Japan's PMDA Clarifies India Plans Amid Asian Co-Operation (SCRIP-$)


  • Ampicillin injection and Amoxycillin injection - medicine shortages (TGA)
  • Harvoni - Australian Public Assessment Reports for prescription medicines (TGA)

Ebola Outbreak

  • Guinea records three new cases of Ebola, brings total to nine (Reuters)
  • Photo Feature: After Ebola, Sierra Leone’s burial workers fear a bleak future (IRIN)

Other International

  • New Pressure Sensitive Thin Film Controls Orthotic Arm for People with Essential Tremor (medGadget)
  • Brazil: Federal District Court in Rio de Janeiro Declares AstraZeneca’s Patent Covering Fosladex Invalid (National Law Review)
  • WHO’s Removal Of Nigeria From Polio-Endemic List ‘Should Have’ Received More Attention (Kaiser) (Humanosphere) (WHO)
  • Taiwan Grapples with Record Outbreak of Dengue Fever (VOA)

General Health and Other Interesting Articles

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

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

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