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Regulatory Recon: 'Practical Hurdles' to Outcomes Based Pricing, China FDA Rejects 11 Drugs (12 November 2015)

Posted 12 November 2015 | By Michael Mezher 

Regulatory Recon: 'Practical Hurdles' to Outcomes Based Pricing, China FDA Rejects 11 Drugs (12 November 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

  • Valeant, Ackman must face U.S. insider trading lawsuit (Reuters)
  • Is This the New Beginning of Individual Prosecutions? Probably Not. (FDA Law Blog)
  • Gene therapies offer dramatic promise but shocking costs (Washington Post)
  • Other diagnostic companies utilize regulatory loopholes, not just Theranos (MedCityNews)
  • Novartis, Roche find 'outcome-based' drug pricing an elusive dream (Reuters)
  • Drugmakers Kept One-Third of Trial Results Secret, Study Finds (Bloomberg)

In Focus: International

  • China rejects 11 drug applications over inadequate trial data (Reuters)
  • Pacific trade deal could limit affordable drugs: world health chief (Reuters)
  • AHWP Endorses Text On Reg Best Practice For Combo Products, Among 11 Other Documents (Clinica-$) (Focus)
  • MSF launches global action against GSK and Pfizer over pneumonia vaccine price (Pharmafile) (MSF)
  • China Reforms Welcome, But More Needed: Frazier (PharmAsiaNews-$)
  • Novartis Japan faces censure for delay in disclosing drug side effects (Japan Times)
  • Health Canada issues warning on two AbbVie hepatitis C treatments (PharmaLetter-$)

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US: Pharmaceuticals and Biotechnology

  • OPQ Tests its Team-Based Review Process for Drug Applications (FDANews-$)
  • PCSK9 Patient Assistance Programs: Do ask. Do tell. (DrugWonks)
  • Precision Medicine Initiative: Privacy and Trust Principles (White House)
  • Vaccines For Use During Pregnancy Pose Development Challenges, FDA Says (Pink Sheet-$)
  • AZ halts Dr Reddy's 'purple pill' generic; firm responds to FDA Letter (In-PharmaTechnologist)
  • Cell And Gene Therapy: An “Outside-In” Technology Evolution (LifeSciVC)
  • Acquired Resistance to Bedaquiline and Delamanid in Therapy for Tuberculosis (NEJM)
  • Sorry, kids. There's a nationwide FluMist shortage, so you'll probably have to get a shot. (Washington Post)
  • Germany, U.S. in hot pursuit of 'messenger' drug molecules (Reuters)
  • Top Tips For A Harmonious Drug Development Partnership (SCRIP-$)
  • Patent Cliff: Value of branded drug patent expiries at all-time high (DSN)
  • Lupus: positive results announced from phase III BLISS-SC study of Benlysta (belimumab) (MNT)
  • Postapproval Cardio Studies Challenged By Enrollment, Protocol Issues (Gray Sheet-$)
  • Neos' ADHD Drug Won't Launch Until 2017 As FDA Requires Clinical-Commercial Bridging Study (Pink Sheet-$)
  • AHF: Gilead's new HIV med an attempt to evergreen, avoid patent expiration (BioPharmaDive) (Press)

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

  • Portola reversal agent for Xarelto succeeds in late stage trial (Reuters)
  • FDA eases up on Forum's schizophrenia program with Alzheimer's trials still on hold (FierceBiotech) (SCRIP-$)
  • Alnylam, Medicines Co cholesterol drug effective for six months: study (Reuters)
  • World first blood cancer drug trial reveals life-changing results (MNT)
  • Concert Pharmaceuticals Initiates Phase 1 Multiple Ascending Dose Trial with CTP-656 for Cystic Fibrosis (Press)
  • Perrigo gets FDA approval for generic KlorCon (DSN)
  • miRagen Therapeutics Initiates First Clinical Trial for Anti-Fibrosis Product Candidate MRG-201 (Press)
  • BMS to Present New Data for Opdivo in Advanced Melanoma, as Monotherapy and in Combination with Yervoy, at the Society for Melanoma Research 2015 International Congress (Press)
  • Allena Pharmaceuticals Announces Presentation of Successful Phase 2 Data from ALLN-177 Program at American Society of Nephrology Kidney Week (Press)
  • Derma Sciences Announces Results of Futility Analyses for Phase 3 Clinical Trials of Aclerastide in Diabetic Foot Ulcer Healing (Press)

US: Medical Devices

  • MD Labs brings pharmacogenetics to masses (DSN)
  • Tired of regulatory delays, hacker patients build their own diabetes tech (MobiHealthNews)
  • Exponential Medicine 2015 Day 1: Genomics, Big Data, AI, and Bitcoin? (medGadget)
  • Perspectum Diagnostics Announces FDA Clearance for LiverMultiscan MR Imaging Device (Press)
  • Blood test detects when hormone treatment for breast cancer stops working (MNT)
  • Qualcomm Exec Urges Device Firms To Focus On Usability (Gray Sheet-$)
  • Quintiles upgrades Apple ResearchKit with open source additions (FierceMedicalDevices)
  • Expedited Access for the Wearable Artificial Kidney (MDDI)

US: Assorted and Government

  • Group seeks more funds for FDA drug approvals (The Hill)
  • Health Data Co. Denies Duty to Protect Patient Info (Law360-$)
  • More than 100 women say birth control mix-up led to unplanned pregnancies (CBS)
  • Valeant Pharmaceuticals' Dizzying Fall From Investors' Good Graces (Forbes)
  • For US Hospitals, A Mixed Report In Electronic Health Record Adoption (Health Affairs Blog)
  • Horizon Infected By Valeant Scandal (SCRIP-$)
  • CMS Proposal Would Plug Up Watchman Reimbursement (CardioBrief)
  • “Scoring” Savings From Obesity Drugs: CBO Points To Gap Between Categories In Rx Labels And Economic Impact (Pink Sheet-$)
  • Cannabis(ness), Patient, or Recreational User be Assured They Will Not be Subject to DOJ Enforcement for Activities in States that have Legalized Marijuana? (FDA Law Blog)
  • Evening Things Out Some With Trial Evidence Rulings In A Bellwether Case (Drug and Device Law)

Upcoming Meetings and Events              


  • Three new drugs approved for use in Scotland (Pharmafile)
  • Celltrion files CT-P10, proposed Mabthera biosimilar to EMA (BioSimilarNews)
  • Antibiotics use rising in England's deprived areas (PharmaTimes)
  • 'European companies will not be able to follow the exact path to operational compliance as their US counterparts,' says IMS Health survey (Pharmaceutical Commerce)
  • European Medicines Agency signs four-year deal for AdisInsight (Press)
  • 'Alarming' fall in flu jab take-up, warns RCGP (OnMedica)



  • Prevention And Private-Public Partnerships Lie At The Heart Of China's Latest Health Care Initiative (Clinica-$)
  • ISPE Names AstraZeneca China Facility of the Year Winner (Pharmaceutical Manufacturing)


  • Font Size, 'Look-Alikes' And Costs Are Top Concerns In Australian Drug Labeling Review (SCRIP-$)

Other International

  • Brazil tests man for Ebola, puts others under observation (Reuters)
  • New Nigerian Minister of Health is Early Supporter of Guided Therapeutics' LuViva Advanced Cervical Scan use in Africa (Press)

General Health and Other Interesting Articles

  • Maternal deaths fell 44% since 1990 – UN (WHO)
  • Outer space: The final frontier of biopharma R&D (BioPharmaDive)
  • Why Tuberculosis Is Back (NYTimes)
  • New vaccine could prevent high cholesterol (Science Daily)

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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