Regulatory Recon: FDA Rejects Amgen Drug Mylan May Have Violated Antitrust Law With Exclusionary School Contracts (25 August 2016)

Posted 25 August 2016 | By Michael Mezher 

Regulatory Recon: FDA Rejects Amgen Drug Mylan May Have Violated Antitrust Law With Exclusionary School Contracts (25 August 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Mylan may have violated antitrust law in its EpiPen sales to schools, legal experts say (STAT)
  • Why Mylan's 'savings card' won't make EpiPen cheaper for all patients (Washington Post) (NYTimes) (Reuters)
  • Mylan Raised EpiPen's Price Before the Expected Arrival of a Generic (NYTimes)
  • Another Drug Pricing Ripoff (NYTimes)
  • The High Cost of Prescription Drugs in the United States (JAMA)
  • Tying drug price to exclusivity is just a simplistic beat in a complex cadence (BioWorld)
  • PhRMA and BIO Offer Glowing Support for PDUFA VI Performance Goals (Focus)
  • Impurity Deficiencies: How FDA Can Refuse-to-Receive an ANDA (Focus)
  • FDA Warns Indian API Maker Unimark for Deviations at Two Facilities (Focus)
  • PTAB Scraps 2 Teva Copaxone Drug Patents After Review (Law360-$) (Pharmafile)
  • FDA Rejects Amgen Kidney Drug (Fierce) (BioCentury) (The Street) (Press)
  • Eli Lilly Loses Patent Case as Judge Gives Win to Generics (FDANews-$)
  • Drug price hikes can damage company reputations: White House (Reuters)
  • The Story of 3 Consent Decrees (FDAZilla)
  • T-cell therapies for cancer: from outsider to pharmaceutical darling (Pharmaceutical Journal-$)
  • Gene Tests Identify Breast Cancer Patients Who Can Skip Chemotherapy (NYTimes) (NPR) (Financial Times)l (NEJM)
  • Health systems: Improving and sustaining quality through digital transformation (McKinsey)
  • Stealthy Biotech Revives Stalled Parkinson's Drug, Reveals Plans In Alzheimer's and ALS (Forbes)             

In Focus: International                                                         

  • Brexit offers opportunities for UK scientists (Financial Times)
  • Putin appoints church historian as science minister (Nature)
  • Astellas UK suspended from ABPI for 12 months for breaking pharmaceutical advertising code (Pharmaceutical Journal)
  • Pfizer unit Hospira and Napp broke APBI code during Remsima push (BioPharmaReporter)
  • Novartis announces positive phase III results for MS drug siponimod (Reuters) (SEC)
  • Korea positioned to be global biopharma powerhouse, says industry association (BioPharmaReporter)
  • Delhi HC deferrs order blocking Gennova's Biosimilar (Economic Times)
  • Over 14,000 women took Sanofi epilepsy drug despite fetus risk: ministry (Reuters)

US: Pharmaceuticals & Biotechnology

  • Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma (NEJM)
  • Medivation's VP of clinical development jumps ship to rival PARP biotech (Fierce)
  • ​Drug manufacturing jobs grow in Mass. despite losses elsewhere (Boston Biz Journal)
  • FDA Spells Out Structured Product Labeling for REMS (FDANews-$)
  • "Go/No Go" Screening Process Can Help Decide Whether to Switch from Batch to Continuous (PharmTech)
  • Accelerating timelines vital to securing slice of biosimilars market, KBI (BioPharmaReporter)
  • New Ph I-IV data management system to provide access to clinical trial data in real time (Outsourcing-Pharma)
  • What no one is telling you about BMS' Opdivo immunotherapy trial failure (MedCityNews)
  • Pharma's Role in Pediatric Medication Adherence (Pharmaceutical Manufacturing)
  • Convenience in Drug Delivery Drives Complexity and Greater Oversight of Evolving Packaging Systems (Pharmaceutical Manufacturing)
  • BIO releases principles on interacting with patient groups (BioCentury)
  • Gilead Sciences Shares Slide on Leerink Price Target Cut (The Street)
  • Could A New Drug Target Prevent Tolerance And Addiction To Opioids? (Forbes)
  • Biotech Exec Miralles Describes Living In Translation (Forbes)
  • Why it's bad to skip prescribed drugs after a heart attack (Reuters)
  • Few Homeless Shelter Workers Are Trained to Administer Heroin Antidote (NYTimes)

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

  • Highland Therapeutics Announces Initiation of Phase 2 Trial for HLD100 in Pediatric ADHD Patients (Press)
  • Mallinckrodt Receives FDA Fast-Track Designation for Synacthen® Depot IND Application (Press)

US: Medical Devices

  • Medtronic's Q1 earnings top expectations despite top-line slip (MassDevice)
  • Gas Relief Drops May Raise Risk Of Contaminated Medical Scopes (NPR)
  • Fujifilm files last PMA module for Aspire Cristalle breast tomosynthesis software (MassDevice)
  • How medical device companies should think about patient engagement (MassDevice)
  • One Month Until U.S. FDA Unique Device Identifier (UDI) Compliance Date for Class II Devices – Tips for Meeting The Deadline  (RegistrarCorp)
  • 3 Levels of Risk Assessment in the Product Development Life Cycle (MDDI)
  • Scientists hope new test could help contain meningitis outbreaks (Reuters)
  • MORE Health to submit radiation therapy planning consult tool for FDA review (MedCityNews)
  • Bio2 Medical wins FDA clearance for embolism-snaring Angel catheter (MassDevice)

US: Assorted & Government

  • Deep Dive Analysis of 2017 Proposed Physician Fee Schedule (Policy and Medicine)
  • The Pinnacle Hip Implant MDL Continues—with a Motion for a Continuance (Drug and Device Law)
  • Surgeon general's letter to clinicians in crusade against opioid abuse (CBS)
  • Still Not Ready for Prime Time: DEA Denies Joint Petitions to Reschedule Marijuana (FDA Law Blog)
  • FDA Is Preparing Guidances that Will Help Food Companies Prevent Foodborne Illness (FDAVoice)

Upcoming Meetings & Events


  • Lee's, Shenogen to develop cancer combo therapy (BioCentury)
  • BeiGene bags approval to start Chinese trials of Lynparza competitor (Fierce)
  • PMDA-ATC Medical Devices Seminar 2016 (PMDA)



  • TGA presentation: ACTRA Workshop - Regulatory Toxicology, 10 years on, 22 July 2016 (TGA)
  • Consultation: Regulation of autologous cell and tissue products and proposed consequential changes to the classification of biologicals (TGA)


  • Costa Rica registers first microcephaly birth linked to Zika (Reuters)
  • Florida governor complains U.S. not doing enough to fight Zika (Reuters)
  • CDC continues to support Florida in response to Zika outbreak(CDC)
  • CDC awards $6.8 million to partners to support Zika response (CDC)

Other International

  • Middle East, North Africa conflicts threaten two decades of health gains: research (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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