Regulatory Recon: States Seek to Expand Generic Price Fixing Suit to 18 Companies Pfizer Beats Profit Estimates in Q3 (31 October 2017)

Posted 31 October 2017 | By Michael Mezher 

Regulatory Recon: States Seek to Expand Generic Price Fixing Suit to 18 Companies Pfizer Beats Profit Estimates in Q3 (31 October 2017)

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

In Focus: US

  • Pfizer beats profit estimates, raises 2017 earnings forecast (Reuters) (AP)
  • US states to expand generic drug price-fixing suit – sources (Reuters)
  • Is $45B the White House's opioid funding ask? (Politico)
  • Trump opioid panel will recommend nationwide drug courts, tightened requirements for prescribers (STAT)
  • Gottlieb: FDA Looking at Packaging, Storage and Disposal Solutions for Opioids (FDA) (Meeting)
  • 10 percent revived by Narcan in MA died within year, study says (Boston Globe) (CNN)
  • Deputy AG: We're making strides in protecting Americans from fentanyl (USA Today)
  • Who wins and who loses if Amazon enters the prescription drug business (STAT)
  • Novartis asks FDA to expand Kymriah's use against blood cancer (Reuters) (Endpoints) (Pharmafile)
  • US needs to improve oversight of labs handling dangerous pathogens – report (Reuters) (GAO)
  • Sanofi Genzyme retreats from its Parkinson's deal with gene therapy upstart Voyager (Endpoints)
  • Verily co-founder jumps to health care venture firm (Axios) (Endpoints)
  • Braeburn's Buprenorphine Candidate Faces Safety Gauntlet At US FDA Panel (Pink Sheet-$)
  • BIO Lobbies For Orphan Tax Credit (BioCentury)
  • US drug pricing watchdog ICER gets funding to expand efforts (Reuters)
  • Final GDUFA I Activities Report Issues – How Does the 5-Years Look (Lachman Consultants)

Sponsored Content: Advice from Regulatory Leaders

In Focus: International

  • Vaccines the world over (Nature)
  • Definition of the concept "similar medicinal product" – Draft Regulation (European Commission)
  • Bristol-Myers, J&J sink cash into a new $95M European biotech fund (Endpoints) (Fierce)
  • MSF charity secures generic hepatitis C drugs for $1.40 a day (Reuters)
  • Close to 3 million people access hepatitis C cure (WHO)
  • Sanofi turns to artificial intelligence to beat flu (Financial Times)
  • Consultations on adoption of European Union guidelines in Australia (TGA)
  • Astellas Reports First Half FY2017 Financial Results, Revises Fiscal Year Outlook (Press)
  • Pharma's betting big on China, but R&D boom still to come (BioPharmaDive)
  • The Latest on China (In The Pipeline)
  • India fights the 'lesser quality' taint in drug manufacturing (BioPharmaDive)
  • Despite phase 2 miss, Daiichi Sankyo wants Glycotope lead antibody for cancer ADC (Fierce)
  • MSF says closing most cholera centers in Yemen as epidemic wanes (Reuters)
  • China approves Allergan's Ozurdex (PharmaLetter)
  • Russia's Biocad confirms to 25 million-euro investment in new pharma plant in Finland (PharmaLetter-$)

Pharmaceuticals & Biotechnology

  • FDA Posts Dug User Fee Lists for Generic Drugs (FDA)
  • Preclinical antibiotic pipeline gets  a pick‑me‑up (Nature)
  • Why the Rova-T delay is anything but irrelevant (EP Vantage)
  • Daiichi Sankyo posts rare cancer data from suspended ENLIVEN test (Fierce)
  • Biosimilar Development Meetings At US FDA Not Just For Talking Similarity (Pink Sheet-$)
  • Verastem plots FDA path forward for troubled cancer med duvelisib (Fierce) (Press)
  • Long-Term Aspirin Use May Reduce Cancer Risk, Finds New Study (Forbes)
  • Valeant to exceed $5 billion debt pay-down goal this week (CNBC)
  • Kirin Holdings to withdraw from 30 year venture with Amgen, sell shares for $780m (Pharmafile)
  • Janssen's Stelara shows improvement in Crohn's symptoms within one week, new findings reveal (Pharmafile)
  • Can Fentanyl Spray Maker Insys Survive As It Distances Itself From Founder Who Was Just Arrested? (Forbes)
  • Can tiny Mustang Bio compete on the CAR-T front with giants like Novartis and Gilead? Manny Litchman aims to find out (Endpoints)
  • Expanding its preclinical attack on Duchenne MD, Sarepta grabs a license for Duke's CRISPR tech (Endpoints)
  • Emergent buys Abec bioreactor to transfer raxibacumab to Baltimore facility (BioPharmaReporter)
  • Stemline wraps positive pivotal trial for its controversial lead cancer drug, clearing a path to the FDA (Endpoints)
  • PhIII dealmaking frenzy in i/o continues as AstraZeneca follows PACIFIC with a new Incyte IDO1 combo (Endpoints)
  • Synlogic Moves Synthetic Biotics To The Clinic For Rare Metabolic Disease (SCRIP-$)
  • Xynomic Pharma to pay over $500 million for rights to novel RAF inhibitor (PharmaLetter-$)
  • Sanofi, Regeneron enlist HBO series 'The Night of' creator to shine light on atopic dermatitis (Fierce)
  • Lilly to Present New Data on Immunology Portfolio at ACR/ARHP Annual Meeting (Press)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • AstraZeneca plans new pivotal lung cancer trial with Incyte (Reuters)
  • GW completes Epidiolex rolling submission (PharmaTimes)
  • Agilis Biotherapeutics Announces Orphan Product Designation Approval in Europe for the Treatment of Friedreich Ataxia (Press)
  • NeoMatrix Therapeutics Enters Clinical Stage as Investigational New Drug Application for NMT-cP12 Goes Into Effect (Press)
  • Chi-Med Initiates FRUTIGA, a Phase III Trial of Fruquintinib in Second-Line Gastric Cancer (Press)
  • Sunovion Presents New Phase 3 Study Analyses Supporting Safety and Efficacy of SUN-101/eFlow® (glycopyrrolate) for the Treatment of COPD (Press)
  • Transgene to Present Additional Immunology Data from the TIME trial with TG4010 in patients with advanced lung cancer at SITC 2017 (Press)
  • Aimmune Therapeutics Announces Publication in The Journal of Allergy and Clinical Immunology: In Practice of Positive AR101 Data from ARC001 Phase 2 Clinical Trial (Press)
  • Dupilumab Significantly Reduced Steroid Use, Asthma Attacks, And Improved Lung Function In A Phase 3 Study Of People With Severe Steroid-Dependent Asthma (Press)
  • Positive Topline Results from First Japan Phase 3 Trial for Roxadustat in Chronic Kidney Disease Patients with Anemia  (Press)

Medical Devices

  • UPDATE on Increased Rate of Major Adverse Cardiac Events Observed in Patients Receiving Abbott Vascular's Absorb GT1 Bioresorbable Vascular Scaffold (BVS) - Letter to Health Care Providers (FDA)
  • Final FDA Guidance on When Medical Device Changes Require New 510(k) Submissions (Emergo)
  • Exact Sciences Plots Expansion Strategy as Cancer Test Sales Boom (Xconomy)
  • FDA: Don't Remove Uterine Fibroids With Ultrasonic Aspirators (Medscape)
  • Physio-Control recalls Cardinal Health-made pediatric AED electrodes (MassDevice)
  • NeuroPace Closes $74M In Funding For A Seizure-Controlling Brain Interface (Forbes)
  • BRH Medical Receives FDA Clearance for its BRH-A2 Combined Ultrasound and Electric Field Stimulation Device (Press)
  • Abbott Announces FDA Clearance for its Alinity™ ci-series Next-generation Diagnostic Systems (Press)
  • Procept BioRobotics launches AquaBeam trial in France (MassDevice)
  • Immunology and Microbiology Devices; Classification of the BCR-ABL Quantitation Test (FDA)

US: Assorted & Government

  • Murray, Wyden Send Trump List of Demands for HHS Nominee (Letter)
  • Implementation of the 21st Century Cures Act: Achieving the Promise of Health Information Technology (HELP)
  • FDA moves to revoke claim that soy protein protects the heart (Reuters) (FDA)
  • Merck Sharp & Dohme Corp. v. Hospira, Inc. (Fed. Cir. 2017) (Patent Docs)
  • Second Circuit Affirms Exclusion of Plaintiffs' Experts – and Summary Judgment for Defendant – in Mirena MDL (Drug & Device Law)
  • Union Sues J&J Over Alleged Remicade Monopoly Plot (Law360-$)
  • New Jersey Proposes New Limits on Manufacturer Gifts and Payments to Prescribers (FDA Law Blog)
  • PTAB Reverses Course, Institutes Review Of Herceptin Patent (Law360-$) (Orange Book Blog)
  • Par Pharma Suit Tests FDA's Drug Pricing Pushback (Law360-$)
  • Health Care Fraudster Gets 2.5 Years For Role In $175M Plot (Law360-$)

Upcoming Meetings & Events


  • Trenches, Silos And Circular Debates: European Health Forum Calls For Collaboration On IP And Medicines Access (Pink Sheet-$)
  • Concept buys Scottish CRO Aquila (PharmaTimes)
  • Evotec invests €15m in AI firm Exscientia (PMLive)


  • Asia Executives To Watch: Alcon Japan New President, AZ International EVP (SCRIP-$)


  • Industry protests at new drug and devices price controls in India (PharmaLetter-$)
  • Health ministry launches training programmes for accredited hospitals to adopt best pharmacovigilance practices (Pharmabiz)
  • Maha FDA issues stop sale notices to curb illegal distribution of Oxytocin, seizes over 50,000 samples (Pharmabiz)
  • DoP directs NPPA to refix ceiling prices of cefriaxone 1 gm injection strictly in accordance with DPCO, 2013 (Pharmabiz)


  • Scheduling delegate's final decisions, October 2017 (TGA)


  • Updated: Certified Product Information Document - Chemical Entities (CPID-CE) (Health Canada) (Guidance)
  • Publication of the Health Canada Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)  (Health Canada) (Addendum)
  • Updated: Glossary of Quality Terms  (Health Canada)

Other International

  • Barriers remain for a drug industry ready to blossom in Brazil (BioPharmaDive)

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.

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles