Regulatory Reconnaissance: Lilly's Potential Blockbuster Gets FDA Approval (22 April 2014)

Posted 22 April 2014 | By Alexander Gaffney, RAC 

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In Focus: US

In Focus: International

  • India's Trial Volunteers put off by camera consent for clinical trials (India Times)
  • The genetic testing amendment in the IVDR (MedicalDevicesLegal)
  • EU Commission Releases Policy Paper on Mobile Health (mHealth) (EC)

US: Pharmaceuticals/Biotechnology

  • Lilly wins approval for potential blockbuster drug Ramucirumab (IBJ) (Fierce) (FDA) (PMLive) (MedPage Today) (SCRIP-$) (BioCentury) (Eli Lilly) (Reuters) (Bloomberg)
  • ASCO off-label access program could be model for compassionate access (BioCentury-$)
  • FDA to again review Gilead's cobicistat, elvitegravir (BioCentury) (SCRIP-$)
  • Pharma Cos. Press FDA For Track-And-Trace Flexibility (Law 360-$)
  • Pfizer agrees to $190 million settlement over generic Neurontin (Reuters)
  • Priority Review Times Slow Considerably as Standard Review Times Fall (Context Matters)
  • FDA Argument For 5-Year NCE Exclusivity Denial Unfounded, Gilead Says (IHP-$)
  • Powerful Narcotic Painkiller Up For FDA Approval (NPR)
  • FDA issued import alert after importer tried to ship saline not approved in U.S. (Fierce)
  • Voice of the Patient: Supporting FDA As Well As Educating FDA (RPM Report-$)
  • NIH Official Shows Little Patience For FDA's Processing of Patient-Input (RPM Report-$)
  • Emerging 'Superbugs' -- and Why Investors Should Care About New Regulations (The Street)
  • FDA Continuing to Evaluate Concerta, Tykerb, Votrient, Nexavar and Sutent (FDA)
  • 34 Drugs Withdrawn by FDA, Sponsors (FDA)

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

  • FDA to again review Gilead's cobicistat, elvitegravir (BioCentury) (SCRIP-$) (Press)
  • Pfizer Announces Positive Top-Line Results from Two Phase 3 Trials of Tofacitinib in Adults with Moderate-to-Severe Chronic Plaque Psoriasis (Press)

US: Pharmaceuticals and Biotechnology: General

  • Patient advocate groups get increasingly involved in drug development (BioFlash)
  • Baxter settles class-action suit for $64 million, denies wrongdoing (Crain's)
  • Biotech's Hard Bargain (New Yorker) (Forbes)

US: Medical Devices

  • Appeals Court Allows Medtronic to Keep Selling CoreValve Device (WSJ-$) (Reuters) (Law 360-$) (Gray Sheet-$) (Mass Device)
  • Apple adds rising star with background in FDA approvals & product testing to medical team (9to5 Mac)

US: Dietary Supplements

  • Long strange trip: The evolution of botanicals since the inception of DSHEA (NI-USA)
  • SCOTUS Justices Critical Of Coca-Cola's View That FDCA Preempts False Label Claims (IHP-$)

US: Assorted And Government

  • Upcoming AdComms by Subject Matter (EyeOnFDA)


  • The genetic testing amendment in the IVDR (MedicalDevicesLegal)
  • EU Commission Releases Policy Paper on Mobile Health (mHealth) (EC)
  • EndoStim bags a CE mark for MRI-safe reflux device (Fierce)
  • Salix Pharmaceuticals and Progenics Pharmaceuticals Announce the Acceptance of Submission to Expand the Use of RELISTOR in Chronic Non-Cancer Pain by the European Medicines Agency (Press)


  • Volunteers put off by camera consent for clinical trials (India Times)
  • Indian regulator seeks to address the nation's substandard drugs problem (Pharma Letter-$)

Japan & China

  • MHLW Japan Issues Warning To Janssen Regarding Xeplion Deaths (PharmAsia-$)
  • Another Needle Discovered In Novartis Drug Voltaren (PharmAsia-$)

Other International

  • On TGA's Reforms and Developments (TGA)
  • Australia: Cessation of acknowledgement letters for Category 3 submissions (TGA)
  • Vietnam Closes Market To 64 Drug Makers Over Substandard Drugs (PharmAsia-$)

General Regulatory And Interesting Articles

  • Bio-Piracy: When Western Firms Usurp Eastern Medicine (Forbes)
  • Who's Protecting Whom From Deadly Toxin? (NPR)
  • Pimp your ride: Personalized prostheses (WaPo)
  • False-positive mammograms have limited effect on anxiety (Reuters)

Regulatory Reconnaissance #302 - 22 April 2014

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.

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