Regulatory Recon: EMA, EC Release Biosimilars Information Guide NICE Rejects Orexigen Weight-Loss Drug (5 May 2017)

Posted 05 May 2017 | By Michael Mezher 

Regulatory Recon: EMA, EC Release Biosimilars Information Guide NICE Rejects Orexigen Weight-Loss Drug (5 May 2017)

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

In Focus: US

  • House Votes To Repeal Obamacare And The Real Fight Begins (Forbes) (Reuters) (NYTimes 1, 2)
  • Political Theater: How A Bill That Nearly All Opposed Managed To Pass The House (KHN) (NYTimes)
  • GOP Cheers a Big Victory. But Has It Stirred a 'Hornet's Nest'? (NYTimes)
  • In Rare Unity, Hospitals, Doctors and Insurers Criticize Health Bill (NYTimes)
  • Health insurers focused on 2018 unknowns for Obamacare market (Reuters)
  • Drug Prices Are Growing At The Slowest Rate In Years. Here's Why It Doesn't Feel That Way (Forbes)
  • FDA to Create Digital Health Unit (Focus)
  • Biosimilars Forum Seeks More Clarity in FDA Draft Guidance on Biosimilar Interchangeability (Focus)
  • Seattle Genetics is throwing in the towel on a $2B Immunomedics pact after venBio goes on the attack (Endpoints)
  • Sales executive for opioid maker was addicted to the drug he promoted (STAT)
  • These five biotech CEOs earned big bucks even as their companies tanked (STAT)
  • The STAT Plus spreadsheet: Salaries and stock prices at 162 biotechs (STAT)
  • J&J ordered to pay $110 million in U.S. talc-powder trial (Reuters)
  • Paratek, a pharma firm in play? (Financial Times)
  • Orphan Drugs: Pursuing Value And Avoiding Unintended Effects Of Regulations (Health Affairs Blog)
  • As Patients Take On More Costs, Will Providers Shoulder The Burden? (Health Affairs Blog)
  • Are new bone drugs from Amgen and Radius cost-effective? Not even close, ICER says (Fierce)
  • FDA On Drug Pricing: Incremental Steps, But No Full-Frontal Assault (Pink Sheet-$)
  • Market watch: Landscape for medical countermeasure development (Nature)
  • Puma Regulatory Exec Resigns As Neratinib Panel Nears (BioCentury)
  • Regulus CEO leaves, axes 30% of staff as FDA hold goes on (Fierce)
  • Reagan-Udall Launching Compassionate Use Navigator (BioCentury)

In Focus: International

  • NICE rejects Orexigen's weight-loss pill (PharmaTimes)
  • EU Urged To Probe Gilead, Novartis, Roche, Aspen Pricing (Law360-$)
  • EMA, EC Release Biosimilars Information Guide (EMA)
  • EMA Updates its Advice for Centralized Biosimilar Applicants  (EMA)
  • Statement of the 13th IHR Emergency Committee regarding the international spread of poliovirus (WHO)
  • WHO to Begin Cancer Biosimilar Prequalification Pilot This Fall (Focus)
  • European Regulatory Roundup: UK Hurries Drug Pricing Bill Ahead of Election (Focus)
  • Pharma Firms Urged To Push For Post-Brexit Regulatory Equivalence Deal (Pink Sheet-$)
  • Dutch To Score Companies On Their Pharmacovigilance Systems (Pink Sheet-$)
  • EU Big Data Task Force Is 'Not Just Another Discussion Forum', Says Chair Thomas Senderovitz (Pink Sheet-$)
  • European Commission Approves Keytruda for Relapsed or Refractory Classical Hodgkin Lymphoma (Press)
  • After a lull, Spain's pharma market set to show signs of stability, report (PharmaLetter-$)
  • AstraZeneca's new formulation tablets receive positive CHMP opinion (EPR)
  • Broad-spectrum agents for flaviviral infections: dengue, Zika and beyond (Nature)
  • Opening remarks at the Ebola vaccines for Guinea and the world event (WHO)

US: Pharmaceuticals & Biotechnology

  • FDA Hits Allegiant Health for Lapses in Controls and Storage (FDANews-$)
  • Biomarin Tops Q1 Estimates (BioCentury)
  • I-O startup Gritstone lures Rousseau from Genentech (Fierce)
  • Dr. Julius Youngner, Polio Vaccine Pioneer, Dies at 96 (NYTimes)
  • How Do Policies on Detailing Affect Branded Drug Rx? (MedPage)
  • BIO blasts Blue Cross Blue Shield report (PharmaLetter-$)
  • Pharma's Great Automation Migration (Pharmaceutical Manufacturing)

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

  • Zafgen Plans Phase II Trial Of Next-Generation Metap2 (BioCentury)

US: Medical Devices

  • 21st Century Cures Act: Debunking Common Misperceptions (MDDI)
  • NovoCure launches 2 pediatric trials of TTFields (MassDevice)
  • FDA labels Medtronic HVAD splice kit recall as Class 1 (MassDevice)
  • Ventricular Assist Device Controllers and DC Adapter by Medtronic Mechanical Circulatory Support (formerly HeartWare Inc.): Class I Recall - Updated Controller, Power Management Software (FDA)
  • FDA Approves Cardiovascular Systems' Replacement Saline Infusion Pump (Press)

US: Assorted & Government

  • How Long is 60 Days? 59 Days and Change, or a Full 60 Days? A New Challenge to PTE Application Timeliness Raises the Issue (FDA Law Blog)
  • Texas's Challenge to the FDA's Authority (Drug & Device Law)
  • Eli Lilly Cleared To Sue Cialis Counterfeiter (Law360-$)

Upcoming Meetings & Events


  • Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 April 2017 (EMA)
  • Industry Welcomes the 3rd European Commission Workshop on Biosimilar Medicines (EFPIA)
  • ALK Abello adds Canada to Acarizax approval list (PharmaLetter-$)
  • Analysis: Health Service Medical Supplies (Costs) Bill (ABPI)


  • Sorrento Therapeutics completes China manufacturing plant (PharmaLetter-$)


  • Pharma cos blamed for rise in antibiotic resistant bacteria, BDMA, Pharmexcil refute allegations (PharmaBiz)
  • Virtual medicine is coming, but India must stand ready to seize the manifold opportunities (Economic Times)
  • Consul General of Turkey visits Maha FDA office, explores exchange of technical knowledge (PharmaBiz)
  • Strides Shasun's plant completes successful USFDA inspection (Economic Times)
  • Jubilant Life to buy Triad Isotopes' radio-pharmacy business (Economic Times)
  • Hetero gets DCGI nod for generic chronic hepatitis C drug (Economic Times)

Other International

  • Mexico reports H7N3 bird flu outbreak on commercial farm: OIE (Reuters)

General Health & Other Interesting Articles

  • Prescribing video games for kids with sensory and attention problems (Reuters)
  • Having adult heart risk factors in childhood tied to mental decline later (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.

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