Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Amgen's Virus Based Immunotherapy (28 October 2015)

Regulatory Recon: FDA Approves Amgen's Virus Based Immunotherapy (28 October 2015)

Posted 28 October 2015 | By Michael Mezher 

Regulatory Recon: FDA Approves Amgen's Virus Based Immunotherapy (28 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

  • FDA seizes around 15,000 bottles of Codeine syrup (Economic Times)
  • India to press drug firms to tackle cough syrup abuse (Reuters)
  • EMA Updates Stakeholders on EudraVigilance System (EMA)
  • FDA Mutual Reliance with EU on Inspections Is Slow Going (Gold Sheet-$)
  • Health Canada and FDA Joint Public Consultation on ICH Guidelines (Health Canada)

US: Pharmaceuticals and Biotechnology

  • Pfizer/Hospira Epogen Biosimilar Rejected; Relief For Amgen (SCRIP-$) (Pink Sheet-$) (BigMoleculeWatch)
  • Briefing Summary: US FDA Posts Advisory Committee Materials About Substances Nominated for the “Bulk Substances Allowed” List – OCT 27-28, 2015 (PCAC) (Tarius)
  • The Evolving Role of Glycosylation Analysis for Biopharmaceuticals (USP)
  • Senator slaps Valeant for sparse response on pricing decisions (FiercePharma)
  • Biotech companies chase elusive peanut allergy treatment (Reuters)
  • A Catalyst to Bring Change to Clinical Research (Geeks Talk Clinical)
  • There’s more to single-use than switching to bags, says Amgen (BioPharma-Reporter)
  • After Eli Lilly flop, Merck adds a futility challenge to huge PhIII anacetrapib study (FierceBiotech)
  • Clinical Trial Partnerships: Driving Forward New Technologies And Collaborations (SCRIP-$)
  • How to Remedy Data Integrity Failures: FDA’s Step-by-Step Approach (Gold Sheet-$)
  • Biosimilar Development Continues to Challenge FDA and Industry (PharmTech)
  • The Role of the FDA's Office of Pharmaceutical Quality (DD&D)

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

  • GSK heart drug flops in study, shingles vaccine on track (Reuters)
  • Amgen, Cytokinetics heart failure drug succeeds in mid-stage study (Reuters)
  • Shire's eye drug data could strengthen bid for Baxalta, says CEO (Reuters)
  • New Phase III data puts Shire's lifitegrast back on track for 2016 launch (Pharmafile)
  • New Sub-Analyses Show Improvement in COPD Patient Outcomes with Spiolto® Respimat® (Press)
  • Shire's OPUS-3 Phase 3 Trial with Lifitegrast Meets Primary and Key Secondary Endpoints, Significantly Reducing Patient-Reported Symptoms for Dry Eye Disease (Press)
  • Phase 3 trial of Adcetris in Hodgkin lymphoma completes target enrolment (European Pharmaceutical Review)
  • Long-Acting Tx for Ocular Itching Shows Efficacy in Phase 3 Study (MPR)

US: Medical Devices

  • FDA Guidance Sought To Fill Anticoagulant IVD Gap (Gray Sheet-$)
  • Ear infection and patient monitoring devices win pediatric competition (FierceMedicalDevices)
  • Edwards Lifesciences beats Q3 forecasts, raises outlook (MassDevice)

US: Assorted and Government

  • A Letter of Support to urge swift confirmation of Robert Califf as FDA Commissioner (Faster Cures)
  • Novartis to pay $390M to settle kickback case, but will execs pay a price? (Pharmalot)
  • FDA Seeks To Resolve First Amendment Suit By Pacira (Gray Sheet-$)
  • Cross-Motions for Summary Judgment Filed in PRADAXA Patent Term Extension Dispute (FDA Law Blog)
  • TPP Biologics Exclusivity Period Maintains The Status Quo (Law360-$)
  • Pfizer Still Looking To Buy A Tax Advantage – And Before Congress Flips (Pink Sheet-$)
  • Another Smack Down for Cymbalta Plaintiffs’ Lawyers (Drug and Device Law)
  • Generic Drug Price Inflation Tackled In Congressional Budget Deal (Pink Sheet-$)

Upcoming Meetings and Events              


  • Pharma Running Up Against Deadline for Assessing Excipient Risks (Gold Sheet-$)
  • EU Guideline On Validating, Assessing Device Trials Overhauled (SCRIP-$)
  • Otsuka kidney drug earns first NICE nod (Pharmafile)
  • ABPI response to the interim report of the Accelerated Access Review (ABPI)


  • Maharashtra urged to hike health spending to Rs 74 bn by 2018 (Economic Times)
  • Antibiotics overuse: ‘India must be part of solution’ (The Hindu)
  • FDA approves Aurobindo’s generic Ultram (DSN)


  • Update on access to TGA Business Services for clinical trial sponsors (TGA)

Other International

  • NGOs ask WHO DG Dr Chan to take steps to insulate WHO from corporate capture & other undue influences (PharmaBiz)
  • Natco Pharma launches Hepatitis C drug in Nepal (Economic Times)
  • TWi Biotech secures patent for diabetes drug in Korea (BioSpectrum)

General Health and Other Interesting Articles

  • Poll: Most Americans Support FDA Regulation Of E-Cigarettes (NPR)
  • Death Rates, Declining for Decades, Have Flattened, Study Finds (NYTimes) (Reuters)
  • Meat Industry Responds To WHO Cancer Report (NPR)
  • Researchers Discover More Than 3,000 Genes in a Little-studied Part of the Human Genome (DD&D)

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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