Regulatory Recon: J&J Hit With $1Bn Verdict in Hip Implant Trial TPP Exit Forces Look at Global Biopharma IP Challenges (2 December 2016)

Posted 02 December 2016 | By Michael Mezher 

Regulatory Recon: J&J Hit With $1Bn Verdict in Hip Implant Trial TPP Exit Forces Look at Global Biopharma IP Challenges (2 December 2016)

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

In Focus: US

  • Approvals of novel molecules set to plunge in 2016 (EP Vantage)
  • A comprehensive map of molecular drug targets (Nature)
  • Drug launch curves in the modern era (Nature)
  • Pharma executives weigh in on possible changes under Trump (Reuters) (SCRIP-$)
  • Only 26 Percent Of Americans Support Full Repeal Of Obamacare, Poll Finds (NPR)
  • Why Don't People Like Pharma Companies? Pfizer and Regeneron CEOs Discuss (Focus) (Business Insider)
  • Top FDA Officials Defend Agency Stance on Stem Cell Therapies (Focus)
  • FDA Issues Draft Guidance on Physiologically Based Pharmacokinetic Analyses (Focus)
  • Mylan CEO Defends EpiPen Price Increases (Focus)
  • Merck CEO Kenneth Frazier: There are ways to 'strengthen and improve' Obamacare coverage (CNBC)
  • How The 21st Century Cures Act Should Support Public Health (Forbes)
  • Alexander: Leader McConnell Announces Senate on Monday Will Take Up "Most Important Legislation of the Year" (Senate HELP)
  • Maryland congressman in running to head NIH? (Science)
  • Will he stay or will he go? Crunch time approaches for FDA's Califf (Fierce)
  • Cancer drugs may remain approved despite lack of benefit (Reuters)
  • Life Inside The Alzheimer's Ward: A Hidden World Revealed (NPR)
  • Johnson & Johnson hit with over $1 billion verdict on hip implants (Reuters) (Pharmafile)
  • Medical device maker Teleflex to buy Vascular Solutions for $1 billion (Reuters)
  • Allergan Sues Drugmakers Over Linzess Generics (Law360-$)
  • Scientific Evidence and Financial Obligations to Ensure Access to Biosimilars for Cancer Treatment (JAMA)
  • Biosimilar Therapy for ERBB2 (HER2)–Positive Breast Cancer (JAMA) (Study)
  • Regenerative Medicine In Cures: Conditional Approval Dropped In Lieu Of 'Breakthrough'-Style Approach (Pink Sheet-$)

In Focus: International

  • Boehringer axes small-molecule discovery ops as R&D focus shifts to immuno-oncology (Fierce)
  • Pharma companies bat for settlement out of court on FDC issue (Economic Times)
  • Fisher & Paykel wins German court case against ResMed (Reuters)
  • Looking back at the biggest deal of 2016: Bayer-Monsanto (Pharmafile)
  • TPP Exit Forces New Look at Global Biopharma IP Challenges (Bloomberg)
  • PRAC warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C (EMA) (Meeting Highlights)
  • NICE approves MSD's Keytruda for new cancer indication (BioCentury) (Pharmafile) (NICE)
  • Brexit: EMA Has A Visit A Week From Potential Hosts (Pink Sheet-$)
  • Brexit: EMA Could Lose Up To Half Its Staff If It Has To Move (Pink Sheet-$)
  • APAC pharma market to see modest growth in 2017 (BioSpectrum)
  • Merck wins UK okay for Keytruda in lung cancer after price cut (Reuters)
  • EMA: Simpler website navigation for regulatory information on human medicines (EMA)
  • China-developed HIV drug could become first long-acting anti-HIV drug worldwide (PharmaLetter-$)
  • New Australian legislation will improve access to medicines and cut red-tape (PharmaLetter-$)
  • Dolutegravir to be available under national health program in Brazil (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • Intellia gears up for human testing of CRISPR with new HQ, set to double staffers (Fierce)
  • Arrowhead Chief Scientific Officer David Lewis Among 34 Laid Off (Xconomy)
  • ASCO releases oncology pathways criteria (BioCentury)
  • New Directions for FDA, Part 2 – Regulatory Matters (Eye on FDA)
  • REMS Requirement Lifted for MS Drug (MPR)
  • Kite Pharma names new senior VP of Supply Chain (Pharmafile)
  • Using Patient-Centric Initiatives and Online Forums to Improve Adverse Event Reporting (Cutting Edge Info)
  • FDA Issues Baxalta Form 483 for Records, Building Issues and Uncorrected observations (FDANews-$)
  • Desmopressin Battle: Ferring Asks FDA To Reject Serenity's Nocturia Drug (Pink Sheet-$)
  • FDA Smacks Down Vanda's Bid To Block Fanapt Generics (Law360-$)
  • Patients need training to use inhalers properly, study finds (Pharmaceutical  Journal)

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

  • FDA approves IND for injectable anti-PD-L1 (BioCentury)
  • Egalet Announces Filing of Supplemental New Drug Application for OXAYDO® to FDA (Press)
  • Ensysce Biosciences Inc. Initiates Phase 1 Clinical Trial to Study PF614, BIO-MD™ Prodrug of Oxycodone (Press)
  • Promedior Announces Completion of Patient Enrollment Milestones in Phase 2 Clinical Studies of PRM-151 in Both Idiopathic Pulmonary Fibrosis and Myelofibrosis  (Press)
  • Sunovion Initiates SEP-363856 Phase 2 Program for Patients with Schizophrenia or Parkinson's Disease Psychosis (Press)

US: Medical Devices

  • BD puts Pyxis ES drug pump into the Internet of Things (Drug Delivery)
  • Nanowear receives FDA clearance for its transformative remote diagnostic monitoring device differentiated by novel cloth-based nanosensor technology (SimplECG™) (Press)

US: Assorted & Government

Upcoming Meetings & Events


  • ABPI gives evidence to Exiting the EU Commons Select Committee on Brexit priorities (ABPI)
  • Medicinal product smuggling in coaches: large quantities of potency preparations confiscated (SwissMedic)
  • GSK Files Regulatory Submission in European Union for Once-Daily Closed Triple Combination Therapy FF/UMEC/VI for Patients with COPD (Press)
  • Propeller inks deal with Italian spirometer maker (Drug Delivery)
  • Abbott's i-STAT Alinity Bedside Blood Testing System Approved for Sale in Europe (MedGadget)


  • Japan approves Medtronic's CoreValve Evolut R heart valve (MassDevice) (Press)


  • Ampicillin injection and Amoxycillin injection - medicine shortages (TGA)


  • Summary Basis of Decision Stivarga (Health Canada)
  • Notice - Validation rules for regulatory transactions submitted to Health Canada in the electronic Common Technical Document (eCTD) format (Health Canada)

Other International

  • U.N. chief sorry for U.N. role in deadly Haiti cholera outbreak(Reuters)

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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