Regulatory Recon: EU Industry Weighs Outcomes-Based Pricing FDA Panel Backs Pfizer Opioid (9 June 2016)

Posted 09 June 2016 | By Michael Mezher 

Regulatory Recon: EU Industry Weighs Outcomes-Based Pricing FDA Panel Backs Pfizer Opioid (9 June 2016)

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

  • FDA Rejects Highest Number of Monthly Generic Drug Applications Ever (Focus)
  • FDA panel backs approval of Pfizer's opioid painkiller (Reuters) (Press) (Fierce)
  • House Looks to Reform Tropical Disease Priority Review Voucher Program (Focus)
  • Boston Scientific to Restructure Operations (WSJ-$) (MassDevice)
  • First PCSK9 Outcome Trial Results Pushed Back To 2017 (CardioBrief)
  • Not Waiting for the Feds, Some States Are Tackling Drug Pricing (Morning Consult)
  • US FDA Commissioner Califf calls on industry to tackle supply chain quality issues (In-PharmaTechnologist)
  • Just When FDA Thought It Was Out, They Pull It Back In: AstraZeneca Raises 505A(o) and Orphan Drug Exclusivity Carve-Outs in CRESTOR Petition (FDA Law Blog)
  • Amgen says migraine prevention drug meets main goal of study (Reuters)
  • Documents Reveal Rogue Laboratory Company's Unorthodox Billing Practices (CardioBrief)
  • Valeant scrambles to restructure Walgreens deal (Financial Times)
  • Yes, Providing Cancer Drugs In Multiple Vial Sizes Could Save Patients And Payers Money (Health Affairs Blog)
  • Ex-Valeant CEO's Pay Structure May Have Increased Dangerous Risk-Taking, Study Says (Forbes)

In Focus: International

  • US and EU Regulators Seek to Reduce Pharma Inspections (PharmTech)
  • Industry weighs radical shake-up of European drug pricing (Reuters) (EFPIA)
  • Researchers Propose Framework to Validate Surrogate Endpoints (Focus)
  • WHO declares Liberia free of active Ebola virus transmission (Reuters) (WHO)
  • Tech-savvy patients from Gulf to China to drive Philips health (Reuters)
  • CFDA's Domestic Pharma Manufacturing Site Inspections Decline Significantly (Focus)
  • NICE issues provisional opinion on Eylea (PharmaLetter-$) (PharmaTimes)
  • Medical advances made despite big business (Financial Times) (Daily Mail)
  • WHO Pilots Faster Pre-Qualification Procedure For IVDs (SCRIP-$)

US: Pharmaceuticals & Biotechnology

  • Novel C. Diff Drug Questioned in FDA Staff Review (Medpage)
  • Combatting Superbugs: U.S. Public Health Responses to Antibiotic Resistance 14 June 2016 (Energy and Commerce)
  • Scientists decipher 11 subtypes in acute leukemia gene study (Reuters)
  • I'm a recovering addict. So why did my doctors give me opioids and leave me on my own? (STAT)
  • FDA Calls for Consumer Representatives to Fill Roles on AdComms (FDA)
  • FDA issues final guidances on interim policy for certain bulk drug substances used in compounding (FDA) (Interim Policy 1, 2)
  • A big victory for lab rats: Congress moves to limit chemical testing on animals (Washington Post)
  • FDA Announces Draft Guidance for Sponsors of Certain Oncology Drugs for Companion Animals (FDA, Draft Guidance)
  • FDA Schedules Arthritis AdComm  for Enbrel Biosimilar - 13 July 2016 (FDA)
  • FDA Schedules AdComm for  Valeant's Brodalumab Injection – 19 July 2016 (FDA)
  • Report Touts Benefits Of Prolonged Medication After Breast Cancer. Is It Persuasive? (Forbes)
  • Most antidepressants not working for children and teenagers – study (The Guardian)
  • Will CAR-T deliver on the promise of widespread therapeutic improvement? (MedCityNews)
  • Vantage point – Patient-reported data gain traction in FDA decisions (EP Vantage)
  • Opioids Need Post-Marketing Data To Inform Abuse-Deterrent Claims, FDA Panel Says (Pink Sheet-$)
  • BsUFA II: What Biosimilar Makers Need From FDA (BioProcessOnline)
  • Pfizer's Lessons On Breakthrough Designation: Be Strategic, Work Hard (Pink Sheet-$)
  • Pfizer's Remicade Biosimilar: Sept. 15 Is Earliest Launch Date (Pink Sheet-$)
  • Antibiotic Development Incentives May Be Tricky to Implement (BIO)

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

  • New Trial 'Justifies' FDA Nod for Ibrance (Medpage)
  • Studies Demonstrate Lilly's Taltz® (ixekizumab) Maintained or Achieved High Levels of Skin Clearance for Patients with Moderate-to-Severe Plaque Psoriasis through 60 Weeks: Results Published in NEJM (Press)
  • Patient-reported outcomes across phase 3 studies of baricitinib demonstrate statistically significant improvements in physical function and quality of life symptoms in patients with rheumatoid arthritis (RA) (Press 1, 2)
  • Galderma Trifarotene Development Program Meets Key Milestone for Lamellar Ichthyosis Orphan Disease (Press)
  • Acorda Presents Phase 1 Data on CVT-427 for Acute Treatment of Migraine at 58th Annual Scientific Meeting of the American Headache Society (Press)
  • Cidara Therapeutics Doses First Patient in Phase 2 Trial of CD101 Topical to Treat Vulvovaginal Candidiasis (Press)
  • Alnylam Initiates Phase 1 Clinical Trial for ALN-TTRsc02, an Investigational RNAi Therapeutic for the Treatment of TTR-Mediated Amyloidosis (Press)
  • ThromboGenics Receives US FDA Approval for New 'Already-Diluted' Formulation of JETREA (Press)
  • Ironwood and Allergan Announce Supplemental New Drug Application for 72 mcg Linaclotide in Chronic Idiopathic Constipation Has Been Accepted for FDA Review (Press)

US: Medical Devices

  • Bill Would Require Doctors to Report Medical-Device Hazards (WSJ-$) (MassDevice) (Gray Sheet-$)
  • What do you need to know to comply with Phase 3 of FDA's Unique Device Identification System? (MedCityNews)
  • Wellness Device Firms Should Follow Regulatory Prompts, Expert Says (Gray Sheet-$)
  • Astute Medical Receives FDA Clearance For NephroCheck Test Improvements Extending Shelf Life (Press)
  • Medtronic launches Valiant Evo TAA device trial (MassDevice)
  • New Data Further Demonstrate Safety Benefits for World's Smallest Pacemaker (Press)
  • FDA clears Ares robot-assisted bronchoscopy device from Auris Surgical Robotics (MassDevice)

US: Assorted & Government

  • Specialty Drug Coverage: Payers Agree On Problem But Not Solutions (Pink Sheet-$)
  • Government Seeks Limits on Short-Term Health Policies (WSJ-$)
  • Ohio governor signs bill legalizing medical marijuana (Reuters)
  • ACLU v. Myriad Genetics, Round 2: The Problem of Governance-by-Guidance (Genomics Law Report)
  • Early Alert: The Food and Drug Administration Does Not Have an Efficient and Effective Food Recall Initiation Process (OIG)
  • Statement on HHS OIG Early Alert on FDA food recall initiation process (FDA)

Upcoming Meetings & Events


  • Biocad Sues Roche Over Alleged Anti-Competitive Pricing Practices of Biosimilars (FDANews-$)
  • New bowel cancer screening test (UK DOH)
  • New data on biosimilars of the big three anti-TNF drugs presented at EULAR 2016 (Pharmafile)
  • Competent Authorities on Substances of Human Origin Expert Group  Meeting Agenda (EC)
  • New biosimilars facility opens in Iceland (PharmaLetter-$)
  • Russia sees decline of drug sales for first time since 2006 (PharmaLetter-$)
  • EFPIA launches Blog Series to Back UN SDGs (EFPIA)


  • Ko Da not at end of regulatory problems: US FDA says Taiwan firm should hire CFR 211 consultant (In-PharmaTechnologist)
  • Catalent opens new clinical supply facility on its Japan campus (BioSpectrum)
  • Takeda gets rights to Theravance's GI candidate (BioCentury)
  • Samsung reports long-term biosimilar switching data (BioCentury)


  • Roche Backs Off Mircera Suit In India (PharmAsiaNews-$)
  • US Agency charges Dr. Reddy's Labs for packaging lapses; company disagrees (Economic Times)
  • Health Ministry begins work on new law for safer drugs (Economic Times)
  • Health ministry planning makeover of laws governing domestic medical devices industry (Economic Times)
  • Made-in-Chennai heart pump to cost one-third (Economic Times)
  • 80% drugs to combat AIDS supplied by India: JP Nadda (Economic Times)
  • Price control on stents not justified in patient's interest: experts (PharmaBiz)
  • Granules acquires rights for 4 products from USpharma Windlas (Economic Times)
  • India cites Taj Pharma in counterfeit BiCNU case (Securing Industry)
  • Industry wants Centre to increase validity of WHO GMP certification from 2 to 5 years (PharmaBiz)


  • Ethicon Physiomesh Flexible Composite Mesh (TGA)
  • Public submissions on scheduling matters referred to the ACMS#16, November 2015 (TGA)



  • Slovenia confirms first case of Zika virus (Reuters)

Other International

  • WHO says new yellow fever case in Congo transmitted locally (Reuters)
  • Consumer Health To Play A Pivotal Role In Merck's Africa Growth Strategy (PharmaAfrica)
  • Four reasons why Africa, Gates and Obama want to end malaria (Reuters)

General Health & Other Interesting Articles

  • This Med School Teaches Health Policy Along With The Pills (NPR)
  • Pregnant women may overestimate risk of some drugs (Reuters)
  • Good oral hygiene linked to reduced risk of head and neck cancers (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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