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Regulatory Recon: Pfizer Hit With Record £84M Fine for Overcharging NHS Mylan Eyes 3,500 Layoffs in Cost Cutting Drive (7 December 2016)

Posted 07 December 2016 | By Michael Mezher 

Regulatory Recon: Pfizer Hit With Record £84M Fine for Overcharging NHS Mylan Eyes 3,500 Layoffs in Cost Cutting Drive (7 December 2016)

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

In Focus: US

  • Senate Republican Leaders Vow to Begin Repeal of Health Law Next Month (NYTimes)
  • Trump Vows to 'Bring Down Drug Prices'; Biotech Stocks Fall (Bloomberg)
  • Sun Pharma Halol Plant Review Resulted in 14-Page FDA Report (Bloomberg) (Reuters) (Economic Times)
  • The Mutual Reliance Initiative: A New Path for Pharmaceutical Inspections in Europe and Beyond (FDA Voice)
  • Mylan eyes up to 3,500 layoffs in post-M&A cost-cutting drive (Fierce)
  • Shoddy Medication? Search Engines May Already Know (MIT Technology Review)
  • Being patient-centric in a digitizing world (McKinsey)
  • Why Pharma Under-Values Novel R&D (Forbes)
  • Guest Post -- The Emergent Microbiome: A Revolution for the Life Sciences -- Part IX, The Microbiome and Immunotherapy II (Patent Docs)
  • US patent agency to weigh rival claims on gene-editing technology (Reuters) (STAT)
  • Standing Up to the Test of Time: Two Cancer Drugs That Could Survive a Hobbled FDA (Forbes)
  • How Will FDA Under @realDonaldTrump Regulate Speech? (FDA Law Blog)
  • The GiveAway Act (CardioBrief)
  • US expands scope of Avastin in ovarian cancer (PharmaTimes) (Press)
  • Chantix's Boxed Warning: Will A Positive Vote Justify A Negative Outcome? (Pink Sheet 1, 2)
  • FDA Warns Spanish API Maker for GMP Violations (Focus)
  • Leahy Looks to Amend 'Cures' Bill as Senate Prepares for (Focus)
  • Sequencing Strategies to Guide Decision Making in Cancer Treatment (PLOS)
  • Precision Cancer Diagnostics: Tracking Genomic Evolution in Clinical Trials (PLOS)
  • Tumor Evolution in Two Patients with Basal-like Breast Cancer: A Retrospective Genomics Study of Multiple Metastases (PLOS)
  • Somatic Genomics and Clinical Features of Lung Adenocarcinoma: A Retrospective Study (PLOS)
  • Pfizer, Avillion's Bosulif comes out on top in first-line CML trial (PharmaTimes)
  • Was FDA Nit-Picking In Criticism Of Pfizer's EAGLES Trial? (Pink Sheet-$)
  • Cascadian Therapeutics Enlarges Breast Cancer Pill Study to Meet FDA Registration Standards (The Street) (Forbes)
  • Jenkins' Retirement From US FDA Was Several Years In The Making (Pink Sheet-$)

In Focus: International

  • Pfizer fined record £84.2m over NHS overcharging (The Guardian) (Financial Times) (Reuters)
  • AstraZeneca's Lisa Anson appointed president of ABPI (Pharmafile)
  • AZ' Tagrisso beats chemo in lung cancer trial (PharmaTimes) (Pharmafile)
  • Japan PM's advisers urge annual review of drug prices (Reuters)
  • Takeda overturns negative EU CHMP opinion for oral drug Ninlaro in 'face-to-face' appeal (InPharmaTechnologist)
  • Chinese anti-trust regulators ding Medtronic for $17m (MassDevice)
  • China is narrowing the U.S. lead in cancer research (Fierce)
  • Waiting For The Perfect Case: Why EMA Has Yet To Hold A Public Drug Safety Hearing (Pink Sheet-$)
  • EU green light for BMS' Opdivo in blood cancer (PharmaTimes) (Reuters)
  • Ethical Guidelines for Human Research Revised (Focus)
  • Asia Regulatory Roundup: CFDA Shifts to Random Inspections (Focus)
  • Twenty reasons why Brexit will be even trickier than we thought (The Guardian)
  • AZ sells Rhinocoart Aqua rights to Cilag (PharmaTimes)
  • Binnopharm may become leading player in Russian OTC drugs market (PharmaLetter-$)
  • Global drugmakers slam latest Russian initiatives on drug procurement (PharmaLetter-$)
  • NHS England is 'failing rare disease patients,' charity says (PharmaLetter-$)
  • Indian-made fake erectile dysfunction meds seized in Switzerland en route from Serbia (InPharmaTechnologist)

US: Pharmaceuticals & Biotechnology

  • Whitepaper: Understanding the links between drug delivery route and in vitro test methods (EPR)
  • Kymab's antibody shows early promise in GvHD prophylaxis (PharmaTimes)
  • Janssen reveals positive results from longest follow-up of Imbruvica (Pharmafile)
  • AbbVie/J&J's Imbruvica On Track For New Indication In Graft-Versus-Host Disease (SCRIP-$)
  • Raising the curtain on cerebral malaria's deadly agents (NIH)
  • Amgen teams with NPR-famed StoryCorps to collect and share myeloma stories (Fierce)
  • Costs vary for moisturizers used to ease eczema in babies (Reuters)
  • Expression of lncRNAs in Low-Grade Gliomas and Glioblastoma Multiforme: An In Silico Analysis (PLOS)
  • Regulus adds two more projects to pipeline as it works to get lead hep C drug back on track (Fierce)
  • Hypogonadism Trial Designs: FDA Panel Favors Symptom Assessments, Fertility Measures (Pink Sheet-$)

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

  • AbbVie's phase 2 PARP study misses survival endpoints; hopes rest on bigger phase 3 (Fierce)
  • Phase III Studies Present Additional Evidence for REVLIMID® (lenalidomide) as Maintenance Therapy in Multiple Myeloma (Press)
  • KEYTRUDA® (pembrolizumab) Demonstrated Improved Health-Related Quality of Life Compared to Chemotherapy in First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) (Press)
  • Revance Announces Initiation of Subject Dosing in the SAKURA Phase 3 Clinical Program of RT002 Injectable for the Treatment of Glabellar (Frown) Lines (Press)
  • Aerie Pharmaceuticals Completes Enrollment of Mercury 2 Phase 3 Registration Trial of Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% (Press)
  • Clonal Evolutionary Analysis during HER2 Blockade in HER2-Positive Inflammatory Breast Cancer: A Phase II Open-Label Clinical Trial of Afatinib +/- Vinorelbine (PLOS)

US: Medical Devices

  • Hearing Aid Debate Reaches Congress (MDDI)
  • Gordian Surgical Completes $2.25 Million Raise and Receives FDA Clearance for TroClose1200™ (Press)
  • Medtronic and Fitbit Partner to Integrate Health and Activity Data Into New CGM Solution for Simplified Type 2 Diabetes Management (Press)
  • One Drop Announces FDA Clearance And One Drop | Premium Launches In US, UK, And EU  English (Press)
  • Voluntis gets both FDA and CE Mark for diabetes management app, Insulia (mobihealthnews)

US: Assorted & Government

  • Owner Of Parsippany-Based Diagnostic Testing Facility Sued For Submitting False Claims To Federal Health Care Programs (DoJ)
  • Why FDA Is Making Data Extracted from Reports of Adverse Events for Foods and Cosmetics Available to the Public (FDAVoice)
  • Hospitals warn Trump, Congress of massive losses with Affordable Care Act repeal (Washington Post)
  • U.S. insurer lobby group seeks delay in 2018 Obamacare deadline (Reuters)
  • Obamacare Repeal Without 'Replace' Doubles Uninsured To 59 Million (Forbes)
  • Philip Morris seeks U.S. approval to market alternative cigarette (Reuters)
  • Senate leader pushes for extension of coal miner healthcare (Reuters)
  • Medicines Co. Gets Fed. Circ. Grilling On Blood Thinner IP (Law360-$)
  • 11th Circuit Upholds Stent Defense Verdict (Drug and Device Law)
  • Gilead Uses Merck As Shield In $2.5B Idenix Patent Fight (Law360-$)
  • Providing Clear and Transparent Patent Quality Metrics (USPTO)

Upcoming Meetings & Events


  • UK CRO Ergomed buys out competing Pharmacovigilance firm in Prague for £6.8m (OutsourcingPharma)
  • Medtronic wins expanded CE Mark indication for Endurant II stent graft (MassDevice)


  • Turkey Works To Expand Non-Rx Drug List (Pink Sheet-$)
  • Astellas Launches Kiklin® Granules, a Treatment for Hyperphosphatemia, in Japan (Press)


  • 79 demand notices issued to drug cos for overcharging: Govt (Economic Times)
  • HC seeks Centre's stand on fixing MRP of coronary stents (Economic Times)
  • Suven Life gets patent for neuro-degenerative drug (Economic Times)


  • TGA presentation: International Society for Cellular Therapy Australia and New Zealand Regional Meeting, 12 November 2016 (TGA)
  • Correcting the record: Australia Financial Review story on medicinal cannabis (TGA)


  • New York City Has 5 Babies Born With Zika-Related Brain Issue (NYTimes)

General Health & Other Interesting Articles

  • IUDS, implants may be best birth control for women with diabetes (Reuters)
  • Women Face 20% Higher Health-Care Costs in Retirement, Survey Finds (WSJ)
  • In a Test, Cancer Hospital Customizes Diet to Help Patients (WSJ)

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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