Regulatory Recon: Shire Sues Allergan Over Restasis Contracts; Police Search Merck KGaAs French Facility in Thyroid Drug Inquiry (3 October 2017)

Posted 03 October 2017 By Michael Mezher

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • Celgene joins the heavyweight partner club collaborating with Nimbus (Endpoints) (Forbes) (Fierce)
  • Shire Alleges Allergan Blocked Drug From Medicare Contracts (WSJ) (Reuters)
  • What's next for HHS after Tom Price's resignation (Politico) (The Hill) (Modern Healthcare)
  • Personal Genetic Testing Is Here. Do We Need It? (NYTimes)
  • 4 ways the Trump tax changes could help the pharmaceutical industry (STAT)
  • Examining Patient Access to Investigational Drugs (Energy & Commerce) (Politico)
  • ASCO, Friends of Cancer Research: Trial eligibility criteria should 'promote culture of inclusion' (Healio)
  • Abbvie, Amgen Deal on Humira Biosimilars Likely to Cost CMS More Than $1B (Focus)
  • Allergan responds to mounting criticism of Mohawk patent deal (CNBC) (McCaskill Letter)
  • The US would pay an extra $10.7 billion without generic Allergan drug (STAT)
  • FDA Targets Complex Generic Drugs With New Draft Guidance (Focus) (Reuters) (FDAVoice)
  • On a roll, Rigel flags a positive PhII for its lead, late-stage drug fostamatinib (Endpoints)
  • Phigenix Seeks to Undo Ruling in Genentech Patent Suit (Bloomberg)

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In Focus: International

  • EU drugs head fears delays, health hazards as agency uprooted (Reuters)
  • European Commission Releases EMA Relocation Assessments (European Commission)
  • General Court finds no fault in 2011 appointment procedure of EMA Executive Director (EMA)
  • Track and Trace: What's on the Box? (The Medicine Maker)
  • WHO Announces New Leadership Team (WHO)
  • Oxford team to test universal flu vaccine in world first (Reuters) (Endpoints)
  • Police search Merck KGaA's French plant in thyroid pill inquiry (Reuters)
  • Asian trial backs Takeda and Myovant's relugolix in uterine fibroids (Fierce)
  • Sanofi tasks insider Stefan Oelrich with a tough job: Growing diabetes and Praluent (Fierce)
  • RedHill Biopharma's bowel syndrome drug study meets main goal (Reuters) (Reuters)
  • IMDRF Consults on Use of Registries to Support Device Approval Decisions (Focus)
  • Hard Brexit could cost UK healthcare sector £2bn per year (PMLive)
  • When cost-effective interventions are unaffordable: Integrating cost-effectiveness and budget impact in priority setting for global health programs (PLOS)
  • 'Promising' Status For Faron's Traumakine In UK Opens Possibilities For Early Access, Pricing Negotiations (Pink Sheet-$)

Pharmaceuticals & Biotechnology

  • This Alzheimer's patient stars in a multimillion-dollar ad campaign for pharma. He may soon be homeless (STAT)
  • The Cost of Medications: Current Realities and the Future of Pharmaceutical Pricing Regulations in the United States (Harvard Bill of Health)
  • Top scientists and BD execs craft Cullinan, a $150 million R&D portfolio shop focused on cancer (Endpoints)
  • CureTech reclaims rare disease drug from Pfizer for $20 million (Pharmafile)
  • MaPP Clarifies How OGD will Communicate Deficiencies Found in Initial Filing Review (Lachman Consultants)
  • Range of Risk Evaluation and Mitigation Strategies Platform Standards Initiative: Needs Assessment (FDA) (Assessment)
  • USP-NF Revises Procedures to Recognize Biologic Suffixes (USP)
  • Shoving Regenxbio aside, Ultragenyx's Emil Kakkis closes Dimension buyout deal with 500% premium (Endpoints)
  • Endo, feeling the pricing squeeze, could be the next generics player on the hunt for M&A: Analyst (Fierce)
  • Gilead Sciences Completes Tender Offer for All Outstanding Shares of Kite Pharma, Inc. (Press)
  • The Next Five Years of PDUFA VI: Driving the availability of innovative treatments for patients (PhRMA)
  • Overcoming real-world challenges to maximise the benefit of treatment for patients with multiple myeloma (Pharmafile)
  • Dear Kite: With 2300% upside, we blazed an amazing trail (Endpoints)
  • Precision Medicine: Making Warfarin Safer (NIH)
  • Hepatitis C Drug's Lower Cost Paves Way For Medicaid, Prisons To Expand Treatment (KHN)
  • Determination That SPECTAZOLE (Econazole Nitrate) Topical Cream, 1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)
  • Johnson & Johnson Consumer Inc. et al.; Withdrawal of Approval of 7 New Drug Applications and 71 Abbreviated New Drug Applications (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • AveXis gets FDA nod to start pivotal gene therapy trial (BioPharmaDive)
  • Baxter Enrolls First Patients in U.S. and Colombia Clinical Trials For HDx Therapy Enabled By Theranova (Press)
  • Seattle Genetics and Takeda Announce Publication in Blood of Final Long-Term Survival Data from ADCETRIS® (Brentuximab Vedotin) Pivotal Phase 2 Clinical Trial in Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (Press)
  • FDA awards Roche priority review in HER2-positive breast cancer (Pharmafile)
  • FDA Approves BOTOX® Cosmetic (OnabotulinumtoxinA) for the Temporary Improvement in the Appearance of Moderate to Severe Forehead Lines Associated with Frontalis Muscle Activity In Adults (Press)
  • Roche to initiate testing for Babesia parasite at US Blood Centers under FDA Investigational New Drug Application protocol (Press)
  • Takeda Announces FDA Approval of ALUNBRIG® (brigatinib) 180 mg Tablets (Press)
  • Melior Pharmaceuticals Initiates Phase 2b Study with MLR-1023 for Type 2 Diabetes (Press)
  • Seattle Genetics and Takeda Announce Publication in Blood of Final Long-Term Survival Data from ADCETRIS® (Brentuximab Vedotin) Pivotal Phase 2 Clinical Trial in Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (
  • DiscGenics Receives FDA Allowance of IND to Commence Clinical Study of Its Degenerative Disc Disease Therapy (Press)

Medical Devices

  • FDA'S Role in Medical Device Cybersecurity: Dispelling Myths and Understanding Facts (FDA)
  • FDA Finalizes Product Classification Guidance (FDA Law Blog)
  • US FDA Updates Guidance on Premarket Review Appeals and Deficiency Letters (Emergo)
  • Alere Receives FDA Clearance for Influenza A & B 2 Test (GenomeWeb)

US: Assorted & Government

  • Imported Seafood Safety: FDA and USDA Could Strengthen Efforts to Prevent Unsafe Drug Residues (GAO)
  • Pew Calls for Certification Criteria for Pediatric Electronic Health Records (Pew)
  • Pfizer Loses Bid To Stop Rebate Disclosures To Lawmakers (Law360-$)
  • Roche Ducks Cancer Drug Antitrust Suit (Law360-$)
  • Big Pharma Wants Opioid-Epidemic Class Claims Tossed (Law360-$)
  • PharMerica Looks To Duck Last Claims In Kickback Suit (Law360-$)
  • Few US hospitals can fully share electronic medical records (Reuters)
  • California Bans Prescription Discounts with Generic Equivalents (Policy & Medicine)
  • HHS Will Delay 340B Final Rule Implementation to July 2018 (FDA Law Blog)
  • Innovator Liability, Perpetual Liability Argued in California Supreme Court (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • Requirements according to the Falsified Medicines Directive (Directive 2011/62/EC) (BFARM)

India

  • DoP asks NPPA to take Expert Committee's opinion for fixing ceiling price of methylprednisolone Inj 40 mg/ml (PharmaBiz)
  • Gujarat govt completes groundwork for setting up medical device park at Sanand (PharmaBiz)

Australia

  • Current standards applicable to TGA-licensed HPC manufacturers (TGA)
  • ACSS Public Statement, 14-15 October 2016 (TGA)
  • Uniform recall procedure for therapeutic goods (URPTG) (TGA)
  • Pain - randomised controlled trials and other studies (TGA)
  • Palliation - randomised controlled trials and other studies (TGA)

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 news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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