Regulatory Recon: Pfizer Decides Not to Split Regeneron Gets Priority Review for Eczema Drug (26 September 2016)

Posted 26 September 2016 | By Michael Mezher 

Regulatory Recon: Pfizer Decides Not to Split Regeneron Gets Priority Review for Eczema Drug (26 September 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

  • Pfizer Decides Not to Split, Ending Years of Speculation (Bloomberg) (Reuters) (WSJ)
  • Technology and Health Care: The View From HHS (WSJ)
  • ​Regeneron, Sanofi may win US approval of $3 billion eczema drug by March (WSJ) (Fierce) (Press)
  • FDA Licenses First HUMIRA Biosimilar; Denies AbbVie Petition on Fifth Amendment Takings (WSJ) (FDA) (Patent Docs) (Focus) (FDA Law Blog)
  • Endo International CEO steps down, Campanelli named successor (Reuters)
  • Beware the hype: Top scientists cautious about fighting cancer with immunotherapy (STAT)
  • FDA Lab-Developed Test Oversight Could Spur Gene Test Advances (Bloomberg)
  • Should clinicians prescribe treatments that are more affordable but possibly less effective? (Healio)
  • Recipe for ripoffs: Pricing drugs by their 'value' to sick people (Los Angeles Times)
  • ISO 13485: Ex-FDA Official Kim Trautman Gives Advice on Transitioning (Focus)
  • Doctors Dig for More Data About Patients (WSJ)
  • New Nuclear-Imaging Tests Show Promise in Locating Cancer (WSJ)
  • Physicians and Physicists Join Forces to Fight Pancreatic Cancer (WSJ)
  • GW's cannabis-derived drug succeeds in third epilepsy study (Reuters)
  • Drug-resistant bugs flourish in America's aging water systems (CBS)
  • Patient Advocacy With FDA Review Staff Will Be Tougher Post-Sarepta (Pink Sheet-$)
  • FDA approves expanded indications for Ilaris for three rare diseases (FDA) (Press)
  • Right-To-Try Laws For The Terminally Ill Are Bad Policy (Forbes)
  • Harvard-POLITICO poll: Americans blame pharma on costs (Politico)

In Focus: International

  • GSK files for approval of subcutaneous lupus drug (PharmaTimes)
  • Novartis leads way in new class oENf malaria treatments (PharmaLetter-$)
  • The Ebola crisis then and now: An interview with the UN's David Nabarro (McKinsey)
  • Building A Stronger Ecosystem to Combat Antimicrobial Resistance (LifeSciVC)
  • Six in the running to be next World Health Organization leader (Reuters) (WHO)
  • Lilly's Sarcoma Drug Lartruvo Latest To Test EU Conditional Approval System (Pink Sheet-$)
  • Jim O'Neill Is "Free For Global AMR Role" After Leaving UK Government (SCRIP-$)
  • Glass Ceiling Cracked; Pharma Forges Path To Gender Equality By 2040? (SCRIP-$)
  • We're on your side, NICE boss Sir Andrew Dillon tells pharma (PharmaLetter-$)
  • Dublin The Odds: Ireland Plays On Strengths As It Prepares EMA Bid (Pink Sheet               -$)
  • Australian pharmaceutical market to grow to be worth $25 billion by 2020 (Pharmafile)
  • CytoSorbents enters Iran (MassDevice)
  • Polish police uncover 'world's largest' fake drug factory (Securing Industry)
  • Chinese FDA Adds to Medical Device Submission Document Requirements (Emergo)
  • The Challenge of Health-Care Innovation in Developing Nations (WSJ)
  • Attitudes to animal research in 2016 (GOV.UK)

US: Pharmaceuticals & Biotechnology

  • Califf names Sherman deputy commissioner (BioCentury)
  • Optimizing Clinical Drug Product Performance: Applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid. (Journal of Pharmaceutical Science)
  • Controversy Continues Over Muscular Dystrophy Drug, Despite FDA Approval (NPR)
  • Sick Children Face Potentially Deadly Danger: Medication Errors (WSJ)
  • Deep-sea microbes, simple medical diagnostic tools and complex computing win 2016 MacArthur 'genius grants' (Nature)
  • FDA Publishes Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022 (FDA Lawyers Blog)

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

  • Biogen Completes Rolling Submission of New Drug Application to FDA for Nusinersen as a Treatment for Spinal Muscular Atrophy (Press)
  • Medivir: Updated Interim Phase IIa Data Demonstrate That the Combination of Simeprevir, Odalasvir and AL-335 Has a High Level of Efficacy in HCV Patients (Press)
  • First Patient Dosed in CANbridge's CAN-008 Phase I/II Trial in Newly-Diagnosed Glioblastoma Multiforme in Taiwan (Press)
  • Cytori Partner Kerastem Completes Enrollment of US Phase II Trial for Early Stage Hair Loss (Press)
  • Exelixis Announces Collaborator Daiichi Sankyo's Initiation of Phase 3 Clinical Development for CS-3150, a Selective Mineralocorticoid Receptor Antagonist (Press)
  • Promising Tanibirumab Trial Boosts PharmAbcine's Confidence (SCRIP-$)
  • Alnylam Reports Positive Initial Results from Ongoing Phase 1/2 Study of ALN-GO1, an Investigational RNAi Therapeutic for the Treatment of Primary Hyperoxaluria Type 1 (Press)
  • U.S. FDA Approves Labeling Update of REXULTI® (brexpiprazole) For Maintenance Treatment of Schizophrenia (Press)
  • Ibrutinib (IMBRUVICA®) Supplemental New Drug Application Submitted to FDA for Marginal Zone Lymphoma (MZL) (Press)
  • DURECT's Licensee Pain Therapeutics Receives Complete Response Letter from FDA for REMOXY® ER (oxycodone) Extended-Release Capsules CII (Press)
  • AbbVie's eight-week HCV regimen leads to 98% SVR12 (BioCentury)
  • J&J six-week combo cures all HCV patients in Phase II cohort (BioCentury)

US: Medical Devices

  • Medtronic opens diabetes HQ in Minn (MassDevice)
  • FDA Planning Board Unveil Priorities For Coordinating Center Overseeing Device Evaluation System (MDDI)
  • How to Apply FDA's 3-D Printing Guidance to Medtech Manufacturing (MDDI)
  • Vela Diagnostics Receives FDA Emergency Use Authorization for Zika Virus Molecular Assay (Press)
  • Why We Must Apply Lean Startup Principles to Medical Devices (MDDI)
  • EarPods and EpiPens: The Design Dynamics Behind Permanent Adoption (MDDI)
  • FDA Purchasing Power is on the Line (Alliance for a Stronger FDA)
  • Glaukos touts 3-year iStent data (MassDevice)
  • FDA relabels RebiScan Pediatric Vision Scanner as Class II device (MassDevice)
  • St. Jude gets $4.4M from NIH for app to improve medication adherence in sickle cell anemia patients (MobiHealthNews)
  • UVLrx Therapy Lights Up Charlatans Dealing In Medical Devices (Forbes)
  • Draper Labs plans human study of neural implants (MassDevice)
  • BrainScope Announces FDA Clearance of the First Handheld Medical Device for Assessment of the Full Spectrum of Traumatic Brain Injury (Press)

US: Assorted & Government

  • Rules Amendments Mean That Proportionality Limits Even MDL Discovery (Drug and Device Law)
  • Health Care Deserves More Attention on the Campaign Trail (NYTimes)
  • US politicians lament inaction over price-gouging drug companies (Financial Times)
  • Big Pharma urges acquittal for ex-Acclarent execs (MassDevice)

Upcoming Meetings & Events


  • Pharma 2020 has activated Russian biomanufacturing tech market says GE Healthcare (BioPharmaReporter)
  • Invitation to participate in the EC-EUnetHTA Forum (EUnetHTA)
  • UK Recommends Double Emergency Contraceptive Dose To Counter Enzyme Inducers (SCRIP-$)
  • Medicines For Europe and GPhA Commit To Supporting Positive Developments of the Negotiations for TTP (GPhA)


  • Daiichi's Japan Filing The First For Denosumab In RA (SCRIP-$)



  • Singapore considers monitoring program for babies born to women with Zika (Reuters)
  • Adult, larval insecticides pack deadly punch to mosquitoes, Zika: U.S. (Reuters)
  • Doctors Brace for Zika Babies (NYTimes)

General Health & Other Interesting Articles

  • People who improve their diets reduce diabetes risk (Reuters)

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.

Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles