Regulatory Recon: Merck's Melanoma Immunotherapy Drug Keytruda Approved (5 September 2014)

Posted 05 September 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Merck's Melanoma Immunotherapy Drug Keytruda Approved (5 September 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register here.

In Focus: US

In Focus: International

  • Drug regulators collaborate to tackle Ebola outbreak (PMLive) (ICMRA) (EMA) (EMA)
  • China Readies New Biosimilar Guidelines (PharmAsia-$)
  • China, Taiwan To Cooperate On Clinical Trials, Inspection Data (PharmAsia-$) (BioSpectrum)
  • Good relations with EU auditors could reduce number of surprise inspections (Clinica-$)
  • Australia's federal court rules that companies can patent genetic material (Pharma Letter-$)
  • Ease Regulations For Affordable Biosimilars, Groups Urge (PharmAsia-$)

US: Pharmaceuticals and Biotechnology

  • Merck Skin Cancer Immunotherapy Keytruda Gets FDA Approval (The Street) (Pharmalot) (Fierce) (MedPage Today) (Reuters) (Forbes) (Xconomy) (NYTimes) (FDA) (Merck) (WSJ-$) (BioCentury) (SCRIP-$)
  • Man tied to deadly 2012 U.S. meningitis outbreak arrested (NYTimes) (Reuters) (Law 360-$) (AP) (The Hill) (WaPo) (DOJ) (SCRIP-$)
  • FDA Issues Revised MAPP on Drug Shortages (FDA)
  • Existing Sunscreen Monograph Ingredients Could Fail Proposed Safety Standards (Tan Sheet-$)
  • BASF Sunscreen Ingredient TEA Suffers Identity Crisis In FDA Review (Tan Sheet-$)
  • Wockhardt expects to resolve most FDA concerns within the year (Fierce)
  • A cancer trial scandal and its regulatory backlash (Nature)
  • FDA change of heart benefits a company (BioFlash)
  • Drug black box warnings up post-Vioxx withdrawal (Oncology Practice)
  • U.S. Marshals seize drug products from Company Over Misbranding (FDA)
  • Please Complain: FDA Needs GDUFA Meeting Comments, Presenters (Pink Sheet-$)
  • Court Orders Orange Book Patent Delisting in NUEDEXTA Infringement Litigation; But What’s It Good For? (FDA Law Blog)
  • Follow-up on Visible Particulate Matter in Parenteral Products (Lachman)
  • Examining the Pharma Industry’s Recall Execution Complexities (SteriCycle)
  • FDA Approves Suitability Petition Seeking Application for Generic Feline Hypothydroidism Drug (FDA)
  • Advancing the Use of Biomarkers and Pharmacogenomics in Drug Development (Brookings)
  • Pharmakon Pharma Recalls Products due to Undeclared Excipient (FDA)

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

  • Lilly says peglispro tops Lantus in diabetes trials (PMLive) (Reuters) (AP)
  • Halozyme gets fast track status for PEGPH20 program in metastatic pancreatic cancer (PBR)
  • FDA Removes Partial Clinical Hold on OncoMed's Ipafricept (Press) (BioCentury) (SCRIP-$) (Fierce)
  • Tetraphase On Track For Antibiotic Submission In 2015 (Pink Sheet-$)
  • Prana receives FDA Orphan Drug Designation for PBT2 for Huntington Disease (Press)
  • Actavis Announces FDA Acceptance of the NDA Filing for Ceftazidime-Avibactam, a Qualified Infectious Disease Product (Press)

US: Pharmaceuticals and Biotechnology: General

  • Public Policy 101: Serialization (LillyPad)
  • Walgreen Grapples With Drug-Label Troubles (WSJ-$)

US: Medical Devices

  • PMA Approvals Increase, But Time-To-Decision Data Suggests Possible Slowing Trend (Gray Sheet-$) (Clinica-$)
  • AdvaMed says FDA proposed rule would result in more PMAs, device reclassifications (Fierce)
  • FDA Explores New Uses for MRI Scans (FDA)
  • FDA Wants More Information on Wheelchair Elevators (FDA)
  • FDA Draft Guidance Could Spur Innovation in Diabetes, Cardio Spaces (MDDI)
  • FDA Proposal for Regulating Laboratory Diagnostics Could Improve Patient Care (Hastings)
  • Case Backs Brain Device as Wealthy Push Do-Good Investing (Bloomberg)
  • Huge Class II Recall for Zimmer due to Packaging Errors (FDA)
  • Cedars-Sinai-backed tinnitus app gets FDA clearance (MobiHealthNews)
  • Cook CloverSnare 4-Loop Vascular Retrieval Snare - Snare Tip May Break During Use (FDA)
  • J&J, Ethicon Seek Early Win At Bellwether Pelvic Mesh Trial (Law 360-$)

US: Dietary Supplements

  • Liver Injury Caused by Herbals, Dietary Supplements Rises in Study Population (Press) (Wiley) (Press)

US: Assorted And Government

  • 21st Century Cures Initiative Heading Back to Washington Next Week (E&C)
  • Weekly FDA Enforcement Report (FDA)

Upcoming Meetings

Ebola Outbreak


  • IQWiG finds no added benefit for Astellas’ Betmiga (Pharma Letter-$)
  • Good relations with EU auditors could reduce number of surprise inspections (Clinica-$)
  • England's Cancer Drugs Fund: Naughty or NICE? (PMLive)
  • Majority of British public back animal tests if no alternative (Pharma Times)



  • GSK won't be able to supply 2 million doses of flu vaccine promised for 2014-15 (Canadian Press) (Fierce)


  • Australia's federal court rules that companies can patent genetic material (Pharma Letter-$)

Other International

  • Ease Regulations For Affordable Biosimilars, Groups Urge (PharmAsia-$)

Clinical Trials

  • Pharma firms ‘saving billions’ in research – by giving away their tech (Outsourcing Pharma)

General Regulatory And Interesting Articles

  • Once and for all, bras don’t cause breast cancer (WaPo) (Press)

Regulatory Reconnaissance #393 – 5 September 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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney 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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