Regulatory Recon: FDA Approves Acadia's Nuplazid to Treat Parkinson's Hallucinations France Gets G7 to Weigh in on Drug Pricing (2 May 2016)

Posted 02 May 2016 | By Michael Mezher 

Regulatory Recon: FDA Approves Acadia's Nuplazid to Treat Parkinson's Hallucinations France Gets G7 to Weigh in on Drug Pricing (2 May 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

  • US Approves First Drug for Psychosis Linked to Parkinson's (Reuters) (FDA) (WSJ) (Medpage) (Xconomy) (SCRIP-$) (Press)
  • FDA Approves First Generic Crestor (FDA) (DSN) (Press)
  • House Democrats Trying to Slow Obama Administration Effort to Reduce Drug Prices (Daily Kos)
  • Making Money on Drugs (Washington Post)
  • Buffett, Munger Slam Valeant After Company Released Long Delayed Annual Report (WSJ) (Reuters) (Financial Times) (NYTimes)
  • This Drug Ad Is Not Right for You (Scientific American)
  • Gilead Judge Re-Opens Case Amid Claim Merck Scientist Lied (Bloomberg)
  • Pharos Biologicals Conducting Tests of a Novel Zika Vaccine (Press)
  • Riding Dancing Unicorns Down The Road To Recap (LifeSciVC)
  • Breaking Down Pros and Cons of Preprints in Biomedicine (PLOS)
  • Puerto Rico Zika Cases Now Include 65 Pregnant Women, One Death: CDC (Reuters) (NYTimes)
  • New Implant set to Join Fight Against US Painkiller Epidemic (Reuters)

In Focus: International

  • France Gets G7 to Discuss Global Regulation of Medicine Prices (Reuters)
  • Colombia Moves to Override Patent for Novartis Cancer Drug (STAT)
  • Nurofen Maker Reckitt Benckiser Fined in Australia (BBC)
  • Indian Government May Move Supreme Court to Club all FDC Drugs Ban Cases (Economic Times)
  • Singapore HSA Fine-tuning Good Distribution Practice for Medical Devices (Emergo)
  • Canadian Pharma Group Raises Price of NHS Eye Drug 14-Fold (Financial Times)
  • Pharmexcil, IPMA, Ukraine Sign MoU to Strengthen Pharma Trade (PharmaBiz)
  • Study of Liberia Ebola Flare-Up Shows Need for Longer Vigilance (Reuters) (ICT)
  • Maharashtra FDA Short of 63 Drug Inspectors, 5 Joint Commissioners (PharmaBiz)
  • EMA, FDA Get Together on Drugs Eligible for PRIME and Breakthrough Designation (Pink Sheet-$)
  • Biocon: Japan Biosimilar Glargine Nod To Open Other Doors (PharmasiaNews-$)
  • Experts Fear India Clinical Research May get Hit as Global Regulators Spot Irregularities (PharmaBiz)

US: Pharmaceuticals & Biotechnology

  • CDER Goes Live With Electronic Export Certification System (FDANews-$)
  • Does an FDA Import Alert automatically equate to an impending FDA Warning Letter? (FDA Zilla)
  • W-18 Bears No Relation To The Synthetic Marijuana Chemical JWH-018 (Forbes 1, 2)
  • Manufacturers Concede on Price as Drug Spending Increases (Outsourcing-Pharma)
  • Valeant's CEO Was Key Force on Pricing (WSJ)
  • Putting the Patient in Labeling (And Drug Approval Decisions) in ODE 1 (Pink Sheet-$)
  • CRISPR-Cas9 gene editing tech could eliminate orphan diseases, entrepreneur (BioPharma-Reporter)
  • FDA Making A Generic Case For Continuous Manufacturing (Pink Sheet-$)
  • Duchenne Group's Presentation Is Milestone For Patient Involvement (Pink Sheet-$)
  • Maine Widens Access to Overdose Reversal Drug Naloxone (WSJ-$)
  • EMD Serono, targeting immuno-oncology, to add 150 jobs in Billerica (Boston Globe)
  • Sarepta: FDA Policy Forced AdCom To Vote Against Patients' Interests (Forbes)
  • Is Eteplirsen an Exceptional Case for the FDA? (OZGUR OGUT)
  • Massive failure to publish trial results exposes patients to risks without providing benefits for others (MNT)
  • CDC Says Prioritize Use of Antibiotic for Syphilis After Shortage Announced (MPR)
  • Sarepta, FDA And The Dangers Of Strong Early Results (Pink Sheet-$)
  • Opioid Product Sponsors Eye REMS Fixes To Boost Prescriber Education Uptake (Pink Sheet-$)
  • FDA To Mull Mandatory Opioid Education For Prescribers (Law360-$) (Modern Healthcare)
  • New UK Market Surveillance Levy Could Cost Medtech Companies Millions Each Year (Clinica-$)
  • Scientists Turn Skin Cells into Heart, Brain Cells Using Drugs (DD&D)

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

  • Regeneron Pain Drug Clears Late-Stage Trial (Reuters)
  • BioInvent, Oncurious NV and NMTRC Initiating Phase I/IIa Study with TB-403 for the Treatment of Medulloblastoma (Press)
  • ImmunoGen falls after modifying ovarian cancer trial (BioCentury)
  • FDA expands indication for Teva's ProAir RespiClick (DSN)
  • NightstaRx reports long-term benefits of gene therapy for inherited form of progressive blindness (MNT)
  • CEL-SCI Reports Record Monthly Patient Enrollment in April for Its Phase 3 Head and Neck Cancer Trial (Press)
  • Seres Therapeutics Announces Achievement of Target Enrollment of SER-109 Phase 2 Study for the Prevention of Recurrent Clostridium difficile Infection (Press)
  • TRACT Therapeutics, Inc. Received FDA Approval for a Phase 2 Trial Using a Patient's Immune Cells to Prevent Organ Rejection (Press)
  • FDA approves Bayer's Gadavist (gadobutrol) injection as first contrast agent for use with magnetic resonance angiography of supra-aortic arteries (Press)
  • Eisai Announces FDA Approval of FYCOMPA® (perampanel) Oral Suspension for Adjunctive Therapy in the Treatment of Partial-Onset Seizures and Primary Generalized Tonic-Clonic Seizures (Press)

US: Medical Devices

  • Abbott + St. Jude Medical: What does it mean for med tech innovators? (MassDevice)
  • Stryker acquires British orthopedic implant manufacturer (Modern Healthcare)
  • Zuckerberg Signals Wide Use of Artificial Intelligence On Internet For Medical Uses (Forbes)
  • Potential Regulation of Clinical LC/MS Tests to be Discussed at FDA Workshop Next Week (Genome Web)
  • CHIME wants 'assurance' of med device interoperability (Fierce)
  • Abbott Tried To Pull Out Of Alere Deal, But It Remains On For Now (Gray Sheet-$)
  • Clinical Groups Call For 'Me-Too' Pathway For Infectious Disease LDT Approvals (Gray Sheet-$)
  • Synaptive Medical Receives FDA Clearance for Health Informatics Platform (Press)
  • EnteroMedics inks deal with VA distributor for Maestro anti-obesity device (MassDevice)
  • Corsens Medical Ltd., Announces Filing of a 510(k) Pre-Marketing Notification with the US Food and Drug Administration for the Corsens Cardiac Monitor (Press)

US: Assorted & Government

  • These top scientists want the FDA to have an open mind about e-cigs (Washington Post)
  • Medicare's Drug Payment Proposal Puts Patients First (Huffington Post)
  • Appropriations Trickery in Congress (NYTimes)
  • Dole Knew About Listeria Problem at Salad Plant, F.D.A. Report Says (NYTimes)
  • House bill would speed CMS reimbursement for breakthrough devices (MassDevice)
  • Ransomware: Four Steps to Avoid Becoming the Next Victim (Xconomy)
  • New York Slashes Opioid Use in Childbearing-Age Women (Medpage)
  • Oklahoma governor vetoes bill requiring vaccine information (Modern Healthcare)
  • Pfizer Still Can't Compare Children's Advil To Tylenol In Ads (Law360-$)
  • Preemption: Oregon Has Not Gone Bananas (Drug and Device Law)
  • Pharma CEO Hid FDA Hold From Investors, Jury Finds (Law360-$)
  • NIH Again Closes Drug Product Manufacturing Facilities and Halts Clinical Studies (FDA Law Blog)

Upcoming Meetings & Events



  • 'Pharma imports from China reaches $1.74 billion in April-December 2015' (Economic Times)
  • Korea to Bolster Fast-Track System With Speedier Approvals in Mind (PharmasiaNews-$)
  • Yicheng Goto Pharma Named On USFDA Import Alert (24 Insight)


  • India's Patent Policy Needs More Stakeholder Input, US Trade Office Urges (Pink Sheet-$)
  • Antimicrobial resistance poses serious consequences: J P Nadda (Economic Times)
  • Indian Herceptin Biosimilars Case Simmers (SCRIP-$)
  • Lupin looks to strengthen brand, specialty biz in the US (Economic Times)
  • NGO FIND, Cipla tie-up for Hepatitis C treatment in India (Economic Times)
  • India's Health Ministry Issues List Of Free Diagnostic Services (24 Insight)
  • Marksans Pharma gets USFDA nod for diabetes treatment tablets (Economic Times)
  • Aurobindo Scores USFDA Approval For Generic Vimpat (24 Insight)
  • Glenmark Lands Approval Of Generic Epiduo (24 Insight)
  • Over 50 children die of cancer in India every day, finds study (Economic Times)
  • IDA-Ireland urges Indian pharma cos to invest there by taking advantage of low corporate tax of 12.5% (PharmaBiz)
  • CRI, Kasauli becomes cGMP compliant facility for mfg DPT & TT vaccines (PharmaBiz)


  • Medical Devices Safety Update, Volume 4, Number 3, May 2016 (TGA)



  • Quest gets FDA Emergency Use Authorization for first commercial Zika test (Fierce) (Gray Sheet-$)
  • CDC adds Papua New Guinea to interim travel guidance related to Zika virus (CDC)

General Health & Other Interesting Articles

  • NIH creates Atlas of Human Malformation Syndromes in Diverse Populations (NIH)
  • Norovirus sickens scores on Fred. Olsen cruise ship -US agency (Reuters)
  • Could The Most Effective Birth Control Soon Become The Cheapest? (Forbes)

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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