Regulatory Recon: Eli Lilly Stops Phase III for Heart Drug and an Expanded Indication for Opdivo (12 October 2015)

Posted 12 October 2015 | By Michael Mezher 

Regulatory Recon: Eli Lilly Stops Phase III for Heart Drug and an Expanded Indication for Opdivo (12 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

In Focus: International

  • Some TPP Countries Allowed Transition Periods for Biologics Exclusivity (PharmAsiaNews)
  • Turkey Launches Major New Biologics Projects (PharmAsiaNews)
  • Sientra halts US sales of Implants Made by Brazilian Manufacturer (Reuters) (MassDevice)
  • EMA Orphan Chief On Smart Strategies For Companies (SCRIP-$)

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US: Pharmaceuticals and Biotechnology

  • Advance Science, Don't Pressure FDA On Approvals, Drug Chief Tells Advocates (SCRIP-$)
  • Measles Herd Immunity Won't Hold as Vaccinations Drop (MedpageToday)
  • Controversy over blood pressure trial demonstrates danger of relying on press releases (AHCJ)
  • ANDA Approval Improvements Reveal Just How Big The Backlog Is (Pink Sheet-$)
  • Xarelto, Savaysa, Pradaxa, And Eliquis: Safety Secondary To Ease Of Use Is "A Major Wrong Turn" Says Drug Watchdog Group (Drug Injury Watch)
  • TF Supplements Issues Voluntary Nationwide Recall of All Lots of Rhino 7 3000 and Rhino 7 Platinum 3000 Capsules due to Undeclared Active Pharmaceutical Ingredients (FDA)

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

  • U.S. FDA Grants Priority Review For Daklinza (daclatasvir) sNDAs (BMS)
  • One Year Data from Phase III Study Evaluating Oral OTEZLA® (apremilast) or Injectable etanercept versus Placebo in Patients with Moderate to Severe Plaque Psoriasis Presented at EADV (Press)
  • Clearside Biomedical, Inc. Completes Enrollment in Phase 2 Clinical Trial of CLS-TA Using Suprachoroidal Space (SCS™) Drug Administration (Press)
  • Clinical Study Shows Omega Q Plus® Resveratrol Significantly Increases Coenzyme Q10 Blood Levels (Press)

US: Medical Devices

  • FDA Allows Marketing of the First Nucleic Acid-Based Test to Detect Multiple Pathogens from CSF (ICT) (FierceMedicalDevices)
  • Medtronic touts first implant of deep brain stimulator along with its antinfective technology (FierceMedicalDevices)
  • FDA Greenlights FilmArray For Quick Pathogen Detection (Gray Sheet-$)
  • Advanced device improves health and saves costs for patients with lymphedema (MNT)
  • Apollo uses long-term data to defend Lap-Band, as U.S. obesity device options expand (FierceMedicalDevices)
  • Cook expands Class I Beacon Tip recall (MassDevice)
  • Agilent's Dako Lands FDA Approval for Lung Cancer Complementary Dx (GenomeWeb)
  • USPTO Report to Congress Says No Immediate Action Necessary on Confirmatory Genetic Testing (GenomeWeb)
  • Regulatory Tips for IoT Device Developers (MDDI)
  • TYRX Neuro Absorbable Antibacterial Envelopes Cleared for Use with Implantable Neurostimulators in U.S. (medGadget)

US: Assorted and Government

  • Three Strikes and Out of Court for Breast Implant Opt-Out (Drug and Device Law)
  • Califf FDA Nomination Hearing Expected Before Holiday Season (Gray Sheet-$)
  • FDA seeks comments on potential scheduling change for ketamine (FierceAnimalHealth)
  • False Claims Act Defenses Boosted By Amarin Decision, Attorney Says (Pink Sheet-$)
  • Boston Scientific mesh verdict slashed to $10 million (MassDevice)
  • The U.S. GAO Reports on FDA’s Oversight of Compounded Animal Drugs: FDA Could Improve Oversight with Better Information and Guidance (FDA Law Blog)
  • California to enact comprehensive medical marijuana regulations (Reuters)
  • Presidential candidate Sanders opposes Obama's FDA nominee (Reuters)
  • Ohio Challenges FDA's Stand on Execution Drug (PharmPro)
  • Recommended Recordkeeping for Cosmetic Good Manufacturing Practices (FDA)
  • New Wrinkle In NDI Debate: Supplement Ingredients Used As Drugs Outside US (Tan Sheet-$)

Upcoming Meetings and Events              


  • Irish Health Committee report calls for reduction in the long-term cost of pharmaceuticals (PharmaLetter-$)
  • EU Ruling On Market Exclusivity Period Turns Days Into millions For Drug Companies (SCRIP-$)
  • UK Marketing authorisations granted in September 2015 (MHRA)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 October 2015 (EMA)


  • Government may bar pharmaceutical companies from giving gifts to doctors (Economic Times)
  • NGOs call for cautious approach by Indian govt on resuming negotiations for EU-India free trade agreement (PharmaBiz)
  • Indian pharma majors get 113 ANDAs approval from US FDA in Jan-Sept 2015 (PharmaBiz)
  • Amend D&C Act to make manufacturers accountable for prompt recalling of NSQ drugs from market (PharmaBiz)
  • Unichem gets USFDA nod for generic asthma treatment tablets (Economic Times)
  • TPP, RDP and the Indian Pharma Sector (24 Insight)
  • Indian drugmakers take page from HIV playbook for hep C combo pill (FiercePharmaAsia)



  • Japan Pushing Forward In Global Scrum For Cancer Leads (Pink Sheet-$)

Other International

  • More Thoughts On FDA and ANVISA (RXTrace)

Ebola Outbreak

  • Ebola's persistence in survivors fuels concerns over future risks (Reuters)
  • Antiviral Compound Provides Full Protection from Ebola Virus in Nonhuman Primates (ICT)

General Health and Other Interesting Articles

  • Antibiotic Stewardship Reduces C. diff in Hospitalized Children (ICT)

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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