Regulatory Recon: US Attorneys Investigate Express Scripts Drugmaker Thwarted Plan to Limit OxyContin Prescribing (26 October 2016)

Posted 26 October 2016 | By Michael Mezher 

Regulatory Recon: US Attorneys Investigate Express Scripts Drugmaker Thwarted Plan to Limit OxyContin Prescribing (26 October 2016)

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

In Focus: US

  • The FDA's Controversial Duchenne Drug Approval And The Moral Impulse To Rescue (Health Affairs Blog)
  • FDA's Fears Realized: Sponsors Pitching Investors 'Sarepta Model' (Pink Sheet-$)
  • A Quiet and Sudden Exit for Amiselimod (In the Pipeline)
  • The Challenge Of Providing Early Access To Potential Life-Saving Drugs (Forbes)
  • Generic Drug First-Cycle Approval Rates Lagging Under GDUFA I (Pink Sheet-$)
  • Vertex Pharma Moves Next-Generation Cystic Fibrosis Drugs Into New Clinical Trials (The Street) (Press)
  • EpiPen Competitor Auvi-Q To Return To Market, Promising Lower Costs For Patients (Forbes) (NYTimes)
  • The Feds are starting to dig in at the biggest middle-man in the pharmaceutical game (Business Insider)
  • Drug maker thwarted plan to limit OxyContin prescriptions at dawn of opioid epidemic (STAT)
  • If Monsanto Loses Its Name, What Will Its Haters Have Left to Hate? (WSJ)
  • AstraZeneca Is Now a Competitive Threat to Tesaro in Ovarian Cancer Maintenance Therapy (The Street) (Press)
  • Applying A Silicon Valley Approach To Jump-Start Medical Research (NPR)
  • Solving the Lack of Diversity in Genomic Research (MIT Technology Review)
  • The omens look good for a medtech-only Philips (EP Vantage)
  • Novartis CEO sees tougher US drug pricing over next three-five years (Reuters)
  • Developing the Next Female Viagra? FDA Offers Draft Guidance With Caveats (Focus)
  • FDA Looks to Decrease Adverse Events With New Home-Use Device Label Database (Focus)
  • FDA Adopts New Warning On Abuse And Dependence to Prescription Testosterone (Focus) (Medpage) (FDA)
  • Rules of the PAP road not always clear, even to seasoned travelers (Bioworld)
  • Seventh Circuit Holds that FDAAA Does Not Affect Mensing/Bartlett Preemption (Drug and Device Law)
  • DEA Administrative Decisions Update: DEA's Questionable Practice of (Un)official Notice (FDA Law Blog)

In Focus: International

  • Antimicrobial Resistance in G7 Countries and Beyond (OECD)
  • Boehringer Ingelheim's adalimumab biosimilar candidate shows similar efficacy and safety profile to Humira in pivotal Phase III study (Press)
  • Global Rx pharma market set to grow to 918.74 billion by 2020 (PharmaLetter-$)
  • Novartis says its biosimilar sales should reach $1bn this year (PMLive)
  • NHS drug suppliers investigated over prices (The Guardian)
  • CFDA: reports of clinical trial data fraud 'not fact based' (Outsourcing Pharma)
  • Japan Drug Cost Concerns Rise To The Top (Pink Sheet-$)
  • Exclusive: WHO cancer agency asked experts to withhold weedkiller documents (Reuters)
  • FDA Warning Letter Reveals Data And Sterility Issues At Teva Plant In Hungary (Focus)
  • Asia Regulatory Roundup: CFDA Investigates Trial Sites Over Data Integrity (Focus)
  • UN legal stance on Haiti cholera likely pushed by US: expert (Reuters)
  • Ireland Joins Queue to Host EMA After Brexit (Reuters)
  • Bayer Profit Stokes Concern as Pharma Once Again Eclipses Crops (Bloomberg) (Financial Times) (Press)
  •  Diabetics warned of health risks of suddenly changing life-saving devices without medical supervision (MHRA)

US: Pharmaceuticals & Biotechnology

  • Can your own immune system kill cancer? (CNN)
  • Earnings roundup: Merck, Lilly, Vertex (BioCentury)
  • Breaking Down Barriers to Patient Access (Morning Consult)
  • Simplified Study Aims To Quickly Test A Long-Shot ALS Treatment (NPR)
  • Sickle Cell Disease: Gene-Editing Tools Point to Possible Ultimate Cure (NIH)
  • FDA Updates MAPP for Reviewing Generic Bioavailability and Bioequivalence Studies (FDA)
  • Teva Pharmaceuticals and IBM Expand Global Partnership to Enable Drug Development and Chronic Disease Management with Watson (IBM)
  • Begin Signal Detection Activities Well Before Launch to Support Product Success (Cutting Edge Information)
  • J&J clot fighter battles Pfizer/Bristol for warfarin switches in red-hot market share race (Fierce)
  • How Pharma Cos. Can Shape The Drug-Pricing Landscape (Law360-$)
  • Early Keytruda approval and Bristol's other nasty surprises (EP Vantage)
  • Increased Transparency Requirements With Clinicaltrials.Gov (imarc)
  • Search Approved Animal Drugs on the Redesigned Animal Drugs @ FDA (FDA)
  • Bill Gates foundation gives $210 million to Seattle-based university for global health efforts (Reuters)

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

  • Dynavax Presents Data Showing That HEPLISAV-B Provides Significantly Higher Seroprotection Rates Against Hepatitis B Infection in Populations Known to Have a Reduced Immune Response to Currently Licensed Vaccines (Press)
  • BI unveils new data backing IPF drug Ofev (PharmaTimes)
  • New Results Presented for Opdivo (nivolumab) Demonstrate Encouraging Response Rate in an Expanded Population of Heavily Pre-Treated Classical Hodgkin Lymphoma Patients (Press)
  • Portola submits NDA for betrixaban (BioCentury)
  • Dipexium plummets on total PhIII failure (Fierce) (BioCentury)
  •  Lexicon gains on positive PhII data in Type 1 diabetes (Fierce)
  • Targazyme wins FDA clearance for Phase II bone marrow stem cell study (MassDevice)
  • Entasis Announces Initiation of Phase I Clinical Trial of ETX2514 (Press)
  • Aeterna Zentaris Completes Patient Recruitment for Confirmatory Phase 3 Trial of Macrilen™ (Press)

US: Medical Devices

  • Best Practices for Developing Products Within a Highly Regulated Environment (GxPLifeline)
  • 3M Healthcare's Q3 profits slip (MassDevice)
  • Edwards Lifesciences Shares Fall After-Hours (WSJ)
  • Johnson & Johnson's Ethicon wins FDA nod for expanded Evarrest indication (MassDevice)
  • Spineology wins FDA 510(k) for Rampart Duo interbody fusion device (MassDevice) (Press)
  • Imprimis touts 'dropless therapy' study for cataract surgery (MassDevice)
  • Focal Therapeutics touts BioZorb breast cancer implant data (MassDevice)
  • PharmaJet, Vaccibody collaborate on needle-free HPV vaccine (MassDevice)
  • Second Sight reveals 1st implant of Orion I visual cortical stimulator (MassDevice)

US: Assorted & Government

  • E&C Leaders Press Justice Department for Answers on White House's Obamacare Sue and Settle Scheme (E&C)
  • Massachusetts Institute of Technology v. Shire Pharmaceuticals, Inc. (Fed. Cir. 2016) (Patent Docs)
  • St. Jude, Medtronic Sued Over Heart Valve Patents (Law360-$)
  • NJ Judge Sends Medical Device Co.'s Coverage Spat To Pa. (Law360-$)
  • Nivea Maker Says No Evidence Showing Lotion Is A Drug (Law360-$)
  • BMS Settles with California Insurance Commission – Seems Everyone Is Getting Into the Act (Policy and Medicine)
  • There's no quit in Abbott whistleblower Colquitt (MassDevice)
  • SCORE at Six Months: Meeting the Challenge of Complex Recalls (FDA Voice)
  • As Election Day Nears, Drug Companies Pour $22 Million into California Ballot Battle (National Law Review)
  • U.S. Catholic health group hit with complaint over sterilization ban (Reuters)

Upcoming Meetings & Events


  • New search page for periodic safety update report single assessments (PSUSAs) (EMA)
  • 10 Questions For Bayer's UK CEO On Market Access Reforms In England (Pink Sheet-$)
  • Horizon seals $800m Raptor buy (PharmaTimes)
  • Spanish biotech sector gets a boost with $140 million VC fund (MedCityNews)
  • GSK links with Fimbrion to develop UTI drug (PharmaTimes)
  • UCB launches new Cimzia self-injector in the UK (PharmaTimes)


  • The 5th WHO Interregional Seminar for Quality Control Laboratories involved in the WHO Prequalification held in Shenzhen (CFDA)



  • Summary Safety Review - Tumour Necrosis Factor (TNF) alpha blockers (SIMPONI and CIMZIA) - Assessing the Potential Risk of Liver Inflammation (Autoimmune Hepatitis) (Health Canada)


  • How Relevant Is Sexual Transmission of Zika Virus? (PLOS)
  • Heat, UMiami seek to create fetal Zika vaccine (BioCentury)
  • Rio fights Zika with biggest release yet of bacteria-infected mosquitoes (Nature)

General Health & Other Interesting Articles

  • New gene-editing trick discovered just in time for J-Lo's "CRISPR" TV series (Washington Post)

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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