Regulatory Recon: Pfizer Herceptin Biosimilar Succeeds in Key Study Pharma Companies Argue Against New UK Regulator (30 November 2016)

Posted 30 November 2016 | By Michael Mezher 

Regulatory Recon: Pfizer Herceptin Biosimilar Succeeds in Key Study Pharma Companies Argue Against New UK Regulator (30 November 2016)

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

In Focus: US

  • Donald Trump Signals Big Health Policy Changes Are Coming (NYTimes)
  • The Food and Drug Administration: Six Important Ideas (Morning Consult)
  • Pfizer's Herceptin biosimilar succeeds in key breast cancer study (Reuters) (Press)
  • GOP leaders set for House vote on medical research bill (AP)
  • 21st Century Cures Act reboot keeps controversial changes for FDA (Modern Healthcare)
  • White House Statement on 'Cures' Amendment (
  • New Cures Bill to Reconsider Conflict-of-Interest Rules (Bloomberg)
  • Tom Price, HHS Nominee, Drafted Remake of Health Law (NYTimes) (KHN) (Nature)
  • 10 Questions: Rep. Tom Price, MD (R-Ga.) (Medpage)
  • Will Tom Price take a 'surgical approach' to revising Obamacare? (PBS)
  • Tom Price, a Radical Choice for Health Secretary (NYTimes Editorial Board)
  • Statement on Announcement of Intent to Nominate Rep. Tom Price to Head HHS and Seema Verma to Lead CMS (Sen. Hatch)
  • Your Weekly Reminder That FDA Approval and Insurance Coverage Are Often Linked (Harvard Bill of Health)
  • Should doctors check your electric bill? (Politico)
  • After criticism from scientists, Congress eases its pursuit of faster stem cell therapies (STAT)
  • Rejecting J&J could leave Actelion with 'lot of explaining to do' (Reuters)
  • Drugs That Levitate (C&EN)
  • FDA Agrees to New Trials for Ecstasy as Relief for PTSD Patients (NYTimes) (Pharmafile)
  • Big data promise exponential change in healthcare (Financial Times)
  • Switching course, Gilead markets HIV drug for prevention (Reuters)
  • Prenatal Genetic Test Billing Practices Questioned (CardioBrief)
  • FDA Finalizes Guidance on Providing Postmarket Safety Reports in ICH Format (Focus)
  • How to Mitigate Cross-Contamination During Colonoscopies, Final FDA Guidance Explains (Focus)
  • FDA Warns Chinese Heparin Manufacturer, Reigniting Questions of Contamination (Focus)
  • Noteworthy Takeaways From FDA's 180-Day Exclusivity Forfeiture Decision on Generic EDLUAR (FDA Law Blog)
  • Arrowhead Pharma sinks after shelving three drug programs (Reuters)
  • Meeting with Trump emboldens anti-vaccine activists, who see an ally in the Oval Office (STAT)

In Focus: International                                                                                               

  • Pharma companies argue against new UK drugs regulator (Financial Times)
  • Complexity of new logistics policy may stunt China vaccine industry, Sinovac (BioPharmaReporter)
  • Novo Nordisk reports Tresiba insulin achieves target in study (Reuters) (WSJ)
  • Not One But Two Decisions Fine Tune the Australian Patent Office's Approach to Life Science Technologies (Patent Docs)
  • Boehringer forges hearing loss research deal in China (BioCentury)
  • Industry warns of Brexit uncertainty for thousands of medicines (Reuters)
  • EMA Highlights Central Nervous System Drug Development Challenges (Focus)
  • Asia Regulatory Roundup: India Begins Reviewing Drug Recall Guidelines (Focus)
  • Sanofi Partnership Passes First Test With Delivery of Antibiotic Compounds (WSJ)
  • Science Europe lobby group hit by sudden exodus (Nature)
  • EU drug spending fell after 2008 recession (Pharmaceutical Journal)
  • EMA Accepts Coherus' Pegfilgrastim Biosimilar for Review (Press)
  • Discontinued Formulation of Protonix IV Is Unsafe for Generics, FDA Says (FDANews-$)
  • Second French Trial Tragedy Verdict: No Danger Signs In Lower Dose Triallists (Pink Sheet-$)
  • Takeda plans German plant to support dengue vaccine roll-out (PMLive)
  • Impact of Accelerated Pathways on Method Development, Inter-Agency Collaboration Draw Regulator Discussion at Europe Biotech CMC Strategy Forum (IPQ)
  • Will 10 Million People Die a Year due to Antimicrobial Resistance by 2050? (PLOS)
  • The Dengue Vaccine Dilemma: Balancing the Individual and Population Risks and Benefits (PLOS 1, 2)

US: Pharmaceuticals & Biotechnology

  • Violations of federal antifraud provisions alleged against two hepatitis B treatment producers (Harvard Bill of Health)
  • Patient-Reported Barriers to Adherence to Antiretroviral Therapy: A Systematic Review and Meta-Analysis (PLOS)
  • Pharma Needs To Have A Sense Of Urgency (Forbes)
  • FDA Appears Close To Beginning Trump Transition Process (Pink Sheet-$)
  • Experimental treatments aim to prevent brain damage in babies (Nature)
  • FDA panel to discuss Neurocrine's Ingrezza (BioCentury)
  • How can bulk freeze drying be successfully adopted into pharmaceutical R&D? (Manufacturing Chemist)
  • The Precision Medicine Initiative and Access (Harvard Bill of Health)
  • Losing the Arms Race: Health Policy and Anti-Microbial Resistance (Harvard Bill of Health)
  • Goldman Funnels $51M Into Cloud Tech Company That Fights Fake Drugs (Xconomy)
  • Cystic fibrosis spotlight turns to Galapagos (EP Vantage)
  • How CMOs can fight back against the counterfeit drug market (OutsourcingPharma)
  • How Paul Allen's Foray Into Gene Editing Could Benefit Human Health (Forbes)
  • FDA Announces Minor Use/Minor Species (MUMS) Grant Application Open Period Due January 13, 2017 (FDA)

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

  • New KEYTRUDA® (pembrolizumab) Data to be Presented at 17th World Conference on Lung Cancer Highlight Research Across the Spectrum of Thoracic Malignancies (Press)
  • Novan genital warts treatment meets Phase II endpoint (BioCentury)
  • FDA Accepts for Review a Supplemental New Drug Application to Expand Labeling of Abilify Maintena® (Aripiprazole) for the Treatment of Bipolar I Disorder (Press)
  • Early data on OncoMed's cancer antibodies 'intriguing, but preliminary' (Fierce)
  • Eisai to Present Latest Data on Eribulin at 39th Annual San Antonio Breast Cancer Symposium (Press)

US: Medical Devices

  • Q&A: Lawyer Jeff Gibbs On Future of FDA Regulation of Lab-Developed Tests Under New Administration (GenomeWeb)
  • Cynosure wins Chinese FDA nod for Icon aesthetic system (MassDevice)
  • IBM Unveils Watson-Powered Imaging Solutions for Healthcare Providers (IBM)
  • ConvertX™ Nephroureteral Stent System Receives FDA Clearance (Press)
  • Class 1 Device Recall Greatbatch, Offset Cup Impactor (FDA)

US: Assorted & Government

  • Need Pricey Drugs From An Obamacare Plan? You'll Shoulder More Of The Cost (KHN)
  • Attorney-Client Privilege Held Not to Apply to Nonreporting Employee/Expert (Drug and Device Law)
  • Back to court: Nevro files new patent infringement suit against Boston Scientific (MassDevice)
  • Anthem Begins Defense of Cigna Merger at Antitrust Trial (WSJ)
  • DEA Bans a Cousin of Deadly Synthetic Opioid Fentanyl (WSJ)

Upcoming Meetings & Events


  • EU action to tackle chronic diseases: New Steering Group on Promotion and Prevention meets today! (EC)
  • 156th session of the European Pharmacopoeia Commission (EQDM)
  • One in seven people with HIV in EU unaware they have virus: report (Reuters)
  • NeuroMetrix wins CE Mark for Quell wearable pain relief device (MassDevice)


  • Brief history of medicine in Japan (PharmaLetter-$)
  • Micell begins MiStent clinical trial in Japan (PharmaLetter-$)
  • Massive drop in use of antibacterial drugs in China (Drug Delivery-$)
  • Challenges and Opportunities for Healthcare in Asia Pacific (Medgadget)


  • Minutes of the 74th meeting of drugs technical advisory board held on 15th November, 2016 at DGHS, Nirman Bhawan, New Delhi (CDSCO)
  • Lupin receives USFDA approval for generic drug to treat sleep disorders (Economic Times)



  • Varying entries in the ARTG - medical devices and IVDs (TGA)
  • ACSOV meeting statement, Meeting 12, 12 August 2016 (TGA)

Other International

  • WHO issues new guidance on HIV self-testing ahead of World AIDS Day (WHO)

General Health & Other Interesting Articles

  • Stroke Rates Rising in Younger People (NYTimes)

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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