Regulatory Recon: Pfizer Abandons PCSK9 Drug After Earnings Miss NICE Again Rejects Head and Neck Cancer Drug Erbitux (1 November 2016)

Posted 01 November 2016 | By Michael Mezher 

Regulatory Recon: Pfizer Abandons PCSK9 Drug After Earnings Miss NICE Again Rejects Head and Neck Cancer Drug Erbitux (1 November 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

In Focus: US

  • Study: 'Ubiquitous' Nature Of Painkillers Lands Kids — Even Toddlers — In The ER (KHN) (NYTimes)
  • Pfizer Ends Trials for Cholesterol Drug as Earnings Fall Short (Bloomberg) (Reuters)  (Press)
  • This drug discount program is good for Americans. But pharma wants to gut it (STAT)
  • FDA Finalizes Guidance On Boxed Warning, Patient Decision Checklist For Essure Devices (Focus)
  • A 'Cures' Revival? Congress Looks To Lame Duck Session To Pass Bill Overhauling FDA, NIH (Focus)
  • Also-Ran to EpiPen Reaches for a Closing Window of Opportunity (NYTimes)
  • Dr. Robert Califf and Dr. C. Michael Gibson Discuss: Pragmatic Clinical Trials - The Road Ahead ( 1, 2)
  • Large molecule clinical trials taking longer, costing more (OutsourcingPharma)
  • Why treating diabetes keeps getting more expensive (Washington Post)
  • Cancer survivors take more psych meds than other people (Washington Post)
  • 10 Start-ups to Watch (C&EN)
  • Early report card on quality of FDA news releases: C at best (HealthNewsReviews)
  • From gene editing to death traps, Seattle scientists innovate in race to end malaria (Reuters)
  • Valeant's ex-CEO and CFO 'facing criminal charges' (PMLive) (Forbes) (The Street) (Pharmafile)
  • Aralez Acquires U.S. Rights to AstraZeneca Beta-Blocker (GEN)
  • Genetic testing fumbles, revealing 'dark side' of precision medicine (STAT)
  • Guest Post -- The Emergent Microbiome: A Revolution for the Life Sciences -- Part VIII, The Microbiome and Immunotherapy I (Patent Docs)
  • Leahy, Wyden Alarmed By Decreased DEA Enforcement Of Pharmaceutical Distributors (Senate Committee on Finance)
  • Opioid epidemic: ex-DEA official says Congress is protecting drug makers (The Guardian)
  • What McKesson's Profit Warning Means for Manufacturers and Pharmacies (Drug Channels)
  • Amgen 'unlikely' to launch Humira biosimilar in 2017 due to AbbVie lawsuits (BioPharmaReporter)
  • Cardinal Health Cuts Profit Guidance (WSJ-$)

In Focus: International

  • Biocuba is optimistic about a future without barriers (BioWorld)
  • Australia's TGA Looks To Mirror US FDA, EMA With Two New Expedited Drug Approval Pathways (Focus)
  • NICE says head and neck cancer drug Erbitux is not cost-effective (PharmaLetter-$) (NICE)
  • WHO: New Emergencies Program Faces $200M Funding Gap (Focus)
  • Report: Boston Scientific pauses Lotus Edge heart valve in Europe (MassDevice)
  • Roche's Alecensa approved by Health Canada (PharmaLetter-$)
  • Merck Anti-PD-L1 avelumab under EMA review (BioCentury) (PMLive)
  • Thermo Fisher confident in gaining share of blossoming Korean market (BioPharmaReporter)
  • TaiGen, HEC launch cross-strait newco for HCV combo (BioCentury)
  • Alprolix approved in Switzerland for the treatment of haemophilia B (EPR)

US: Pharmaceuticals & Biotechnology

  • A Conversation with Vinay Prasad, MD: To 'First, Do No Harm,' You Must Start With Good Evidence (ManagedCareMag)
  • On Front Lines Of Price Dispute, Eye Doctors Wary of New Drug Data (Xconomy)
  • Big Pharma Has Broken Its Social Contract: How To Restore Fairness In Drug Pricing (Forbes)
  • Why The Approach To Drug Pricing Has To Change Now (Forbes)
  • What Pricing Critics Get Wrong About Drug Innovation (Forbes)
  • Drug prices: Where do we go after the Election? (Harvard Bill of Health)
  • Draft Guidance: Animal Drug User Fees and Fee Waivers and Reductions (FDA)
  • Hyland's Discontinues Homeopathic Teething Products, FDA Investigation Continues (Forbes 1, 2)
  • ​Trial suggests Flexion's knee injection may be safer for diabetes patients (Boston Biz Journal)
  • Leading Research Advocates Urge Vote for #CuresNow (E&C)
  • Novo Nordisk kills oral insulin, rejigs R&D to address U.S. payers (Fierce)
  • Kamp to Urge FDA to Provide Clear Guidance on Off-label Communication at November Hearing (CHC)
  • How patient groups can address perceived conflict of interest with corporate donors (BioCentury)
  • GE Healthcare invests US$7m in Westborough, MA facility expansion (Manufacturing Chemist Pharma)
  • Influenza antiviral drug use 2010-2015 (Sentinel)

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

  • Novartis gains FDA priority review for ribociclib, as EMA accepts med (Fierce) (Reuters)
  • Experimental treatment clears malaria infections in small clinical study: Novartis (Press)
  • Priority Review for Ariad's brigatinib (BioCentury)
  • Astex Achieves Milestone on US FDA Filing of New Drug Application (NDA) for LEE011 (Ribociclib) Plus Letrozole as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer (Press)
  • Vyome Biosciences Administers First In-human Dose of VB 1953 in U.S. Phase 1 Clinical Study in Patients with Facial Acne Vulgaris (Press)

US: Medical Devices

  • CDRH's Shuren Extols Victories of Flexible Regulatory Approach (MDDI)
  • First Clinical Data of Medtronic Drug-Filled Stent Show Positive Outcomes (Press)
  • When mobile tech becomes medical device (MedCityNews)
  • New method for performing aortic valve replacement proves successful in high-risk patients (NIH)
  • Nanoscale features on implant surface reduce bacterial growth (MassDevice)
  • Exalenz Bioscience Receives FDA Marketing Clearance for its Laboratory System in the United States (Press)
  • Neural Analytics Receives U.S. FDA 510(k) Clearance for Company's Next Generation, Portable Brain Monitoring Information System (Press)

US: Assorted & Government

  • U Of California Sues Boston Scientific Over AFib Devices (Law360-$)
  • Is High-Deductible Health Insurance Worth the Risk? (NYTimes)
  • Blackstone to Acquire Team Health for About $3.2 Billion (WSJ-$)
  • Misjoined Plaintiffs Can't Be Used to Forum Shop (Drug and Device Law)
  • Pfizer, Others Tell High Court PTAB Unfair To Patent Owners (Law360-$)
  • Defendant in U.S. opioid kickback case claims constitutional right to smoke pot (Reuters)

Upcoming Meetings & Events


  • The Calm Before the Storm (BrandwoodBiomedical)
  • UK team of health experts to tackle global disease outbreaks (UK DOH)
  • Development of the European medicines web portal – Reflection Paper (EMA)


  • CFDA Vice Minister Jiao Hong meets Director-General of European Commission DG GROW (CFDA)
  • CFDA Vice Minister Wu Zhen meets Cuban Ambassador to China (CFDA)
  • Christiane Hamacher becomes head of Asia Pacific, Roche Pharmaceuticals (PharmaLetter-$)


  • Indian drugmakers muscle in on biosimilars development (PharmaLetter-$)


  • Medical Devices Safety Update, Volume 4, Number 6, November 2016 (TGA)
  • TGA presentations: Biotherapeutics Association of Australasia 2016 AGM, TGA Workshop & Education Session (TGA)
  • Orchestra and Orchestra Plus programming devices when used with Reply and Esprit pacemakers (TGA)



  • Colombia Is Hit Hard by Zika, but Not by Microcephaly (NYTimes)
  • Zika causes infertility, lasting harm to testes in mice: U.S. study (Reuters)

Other International

  • Tanzania suspends some HIV programs for gay men, says health minister (Reuters)

General Health & Other Interesting Articles

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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