Regulatory Recon: Pfizer Loses UK Patent Appeal for Lyrica ZMapp Found Promising Against Ebola in Human Trial Despite Missing Efficacy Threshold (13 October 2016)

Posted 13 October 2016 | By Michael Mezher 

Regulatory Recon: Pfizer Loses UK Patent Appeal for Lyrica ZMapp Found Promising Against Ebola in Human Trial Despite Missing Efficacy Threshold (13 October 2016)

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

In Focus: US

  • The Cost Of US Adult Vaccine Avoidance: $8.95 Billion In 2015 (Health Affairs Blog) (Study) (Forbes)
  • DEA delays kratom ban, waits for word from FDA (Washington Times) (NPR)
  • Reviews Of Medical Studies May Be Tainted By Funders' Influence (NPR)
  • FDA inks deal with CluePoints to use data to sniff out sloppy or fraudulent clinical trials (MassDevice)
  • Study finds high rate of overdiagnosis from mammograms (Reuters) (Medpage) (Study)
  • The Case Against The Case Against Mammography (Forbes)
  • Study finds Ebola treatment ZMapp holds promise, although results not definitive (NIH) (NEJM)
  • NIH funds additional medical centers to expand national precision medicine research program (NIH)
  • Biosimilar Suffix Detractors Hope Private Studies Build Their Case (Pink Sheet-$)
  • Cardiovascular Toxic Effects of Targeted Cancer Therapies (NEJM)
  • The Illumina mystery (EP Vantage)
  • New Report Investigates Use Of Analytics To Measure Medical Device Quality (Focus)
  • FDA, CDC Find Contaminated Water At Florida Plant Linked To Multistate Outbreak (Focus)
  • Calcium Supplements Linked To Increased Cardiovascular Risk (CardioBrief)
  • Drugmakers respond to growing need for eye treatments (Financial Times)
  • Bluebird Bio Showcases Upgraded Gene Therapy for Rare Blood Diseases (The Street)
  • Sun Pharmaceuticals hit with recall of over 31 thousand bottles of anti-depressants (Pharmafile)
  • Drug Coupons: Helping a Few at the Expense of Everyone (NYTimes)

In Focus: International

  • Pfizer Loses U.K. Patent Appeal Over $4.8 Billion Lyrica Drug (Bloomberg)
  • European Regulatory Roundup: Clinical Trial Delays Prompt EMA to Consider Revising Guidance (18 August 2016) (Focus)
  • Biosimilars to boost growth of Indian pharma sector in next 15 years: Assocham study (PharmaBiz)
  • Biosimilar interchangeability: what's the big deal, asks CPhI delegates? (BioPharmaReporter)
  • China Resources Pharma Attracts Reckitt, Fujifilm to IPO (Bloomberg)
  • UK's MHRA: Products Containing Cannabis Extract Are Medicines (Focus)
  • NICE turns down Janssen's Imbruvica for rare blood cancer (PharmaTimes) (BioCentury)
  • Merck KgaA foresees meeting 2018 objectives and plans for 2022 (Pharmafile)
  • Celltrion Gets Phase IIb Green Light For Universal Influenza Antibody Drug (SCRIP-$)
  • Brexit: UK Gov't Says Retaining The EMA Cannot Be A "Line In The Sand" Matter (Pink Sheet-$)

US: Pharmaceuticals & Biotechnology

  • Diabetes Trials Tend To Eschew Patient-Reported Outcomes (Pink Sheet-$)
  •  Fatigue keeps many Hodgkin survivors from working (Reuters)
  • Study highlights drug-drug interaction risk from two commonly used drugs (Pharmaceutical Journal-$) (Medpage)
  • Merck signs value-based contract with Aetna for Januvia, Janumet (DSN)
  • Revusiran's Failure Revisited (In The Pipeline)
  • Changes in depression symptoms tied to lung cancer survival (Reuters)
  • Adaptimmune stock slides after poor efficacy forces it to add fludarabine to regimen (Fierce)
  • Danaher set to buy purification consumables firm Phenomenex (BioPharmaReporter)
  • Regeneron pumps $300M-plus into Ocular Therapeutix for new Eylea formulation (Fierce)
  • Biotrial: transparency key as CRO moves forward in US (Outsourcing Pharma)
  • Daiichi pens lung cancer pact with Dana-Farber, continuing oncology deal drive (Fierce)
  • Bay Area Researchers Take A CRISPR Cut At Sickle Cell Disease (Xconomy)
  • Kite Pharma Appoints Chris Nowers as Head of Europe to Lead Commercial Operations and Advance the Company's CAR/TCR Therapy Portfolio in the Region (Press)
  • Merck outspends Bristol-Myers Squibb on journal ads for Keytruda (MM&M)
  • FDA Finalizes Two Guidances Concerning Sunscreen TEAs (FDA Law Blog)

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

  • BIOCAD Biotechnology Company Announces the Start of Phase 2 Clinical Trials of an Innovative Drug to Treat Severe Psoriasis. (Press)
  • FDA Fast Track Designation and First Subject Dosing with Lead Candidate CC8464/ASP1807 for the Management of Neuropathic Pain Associated with iSFN (Press)
  • Novartis' Zykadia more effective than chemo, new study shows (Pharmafile) (Fierce)
  • FDA Grants QIDP and Fast Track Designations to VT-1161 for Treatment of Recurrent Vulvovaginal Candidiasis (Press)
  • True North Therapeutics Receives FDA Orphan Drug Designation for TNT009 for the Treatment of Autoimmune Hemolytic Anemia, including Cold Agglutinin Disease (CAD) (Press)
  • Allegro Ophthalmics Announces Positive Topline Results from DEL MAR Phase 2b Trial Evaluating Luminate® in Patients with Diabetic Macular Edema (Press)
  • Sunovion Announces FDA Filing Acceptance of New Drug Application for SUN-101/eFlow® for the Treatment of Patients with Chronic Obstructive Pulmonary Disease (COPD) (Press)
  • C2N Diagnostics Completes Phase 1 Clinical Study of C2N-8E12 (ABBV-8E12) Among Individuals with Progressive Supranuclear Palsy (Press)

US: Medical Devices

  • Injectable Wires for Fixing the Brain (MIT Technology Review)
  • Novocure enrolls 1st patient in phase III brain metastases trial (MassDevice)
  • Tunable hydrogel helps predict tissue response to chemo (MassDevice)
  • St. Jude Medical is only the latest medical device maker to face battery issues (MassDevice)
  • Real-time MRI in stem cell therapy for Parkinson's (MassDevice)

US: Assorted & Government

  • Medical devices a factor in Minnesota Congressional races (MassDevice)
  • Theranos, Walgreen Blood-Test Suits Consolidated In Ariz. (Law360-$)
  • SEC launches probe, investors file suit against Mylan over EpiPen pricing (MassDevice)
  • Survey: 57% of Americans Favor Marijuana Legalization (Forbes) (Reuters)
  • How The 'Cannabis Catch-22' Keeps Marijuana Classified As A Harmful Drug (NPR)
  • New Study: Substantial rebates negotiated in Medicare Part D (PhRMA)
  • Humana Sees Potential Fallout From Lower Medicare Star-Rating Report (WSJ)

Upcoming Meetings & Events


  • BIA calls for additional UK government support for life sciences (PMLive)
  • Protein Sequence Variants, Process Development and Spec Setting Are Generating Queries from EU Biopharmaceutical CMC Assessors (IPQ)
  • EU Pharma Loses €10.2bn, 38,000 Jobs To Counterfeits As "Massive" Track & Trace Obligations Approach (Pink Sheet-$)
  • Generic drugs "save European 100 billion euros per year" (PharmaLetter-$)
  • NeuroVive scraps kidney injury program after PhII miss, wiping 50% off its stock price (Fierce)
  • Sanofi lowers Q3 sales figures from 2015 (Pharmafile)


  • Thermo Fisher clinical services facility in South Korea to support global trials (Outsourcing Pharma)
  • Hoya picks up Performance Optics for $476m (MassDevice)


  • DCGI issues guidance document for functions & responsibilities of zonal, sub-zonal and port offices of CDSCO (PharmaBiz)
  • Centre may push for MAHs participation in ADR reporting in PvPI (PharmaBiz)
  • India pharma firms caught for exporting counterfeit drugs (Securing Industry)
  • Jubilant Life gets USFDA nod for urinary incontinence drug (Economic Times)

General Health & Other Interesting Articles

  • Exercise, Even In Small Doses, Offers Tremendous Benefits For Senior Citizens (KHN)
  • The One Thing To Do To Stop The Obesity Epidemic (Forbes)
  • High-Protein Diets May Negate Some Of The Benefits Of Losing Weight (Forbes)

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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