Regulatory Recon: Review Finds Statin Benefits Understated Pfizer CEO Knocks Clinton's Plan to Curb Drug Price Increases (9 September 2016)

Posted 09 September 2016 | By Michael Mezher 

Regulatory Recon: Review Finds Statin Benefits Understated Pfizer CEO Knocks Clinton's Plan to Curb Drug Price Increases (9 September 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

  • Pfizer CEO says Clinton plan to curb drug prices would hurt consumers (Reuters) (BioCentury)
  • FDA criminal office draws fire from agents and doctors over drug import crackdown (Reuters)
  • A Push to Lower Drug Prices That Hit Insurers and Employers the Hardest (NYTimes)
  • Biosimilar Interchangeability: 'Careful What You Wish For' (Focus)
  • In CRISPR patent fight, geneticist George Church may be called to testify (STAT)
  • A Quick Survey of the Landscape (In the Pipeline)
  • US Health Law Faces Critical Year (WSJ)
  • Just how confident is Arie Belldegrun about Kite's position in the turbulent CAR-T race? He's glad you asked. (Endpoints)
  • Ranking Member Levin Opening Statement at Markup of Health Legislation (House Ways and Means)
  • ICER review of abuse-deterrent opioid formulations open for comment (PharmaLetter-$) (ICER)
  • Biden asks Congress to allow unencumbered Zika funding vote (Reuters)
  • FDA Begins Consultation on Two ICH Guidelines (Focus)               
  • Bacteria Invade Antibiotics And Transform Into Superbugs (NPR)
  • EpiPen prescriptions jumped last month even as outrage grew over price hikes (CNBC)
  • Did Mylan Purposefully Delay Generic Competition's Entry Into The Market? (The Street)
  • NIH award expands landmark Alzheimer's biomarker study (NIH)
  • Cardiometabolic Disease: Big Data Tackles a Big Health Problem (NIH)
  • FDA Plans 'Thorough' Probe of St. Jude Cybersecurity Case (Reuters) (NYTimes)
  • Federal Survey Finds 119 Million Americans Use Prescription Drugs (NPR)

In Focus: International

  • Lundbeck depressed by EU court ruling in 'pay-for-delay' case (PharmaLetter-$) (PMLive) (EFPIA)
  • Head of International Affairs, Emer Cooke, to leave European Medicines Agency (EMA)
  • Statin Trialists Seek To Bury Debate With Evidence (CardioBrief) (Reuters) (MHRA) (The Lancet)
  • Rage Against The Busted Medical Machines (NPR)
  • Genetic Diversity of Enzymes Alters Metabolic Individuality (AMED)
  • Biosimilars' Adaptation In Europe – Considerations Beyond Price (Big Molecule Watch)
  • Biosimilars applications under review by EMA – August 2016 (GaBI)
  • Euro Drug Pricing's Tradeoffs May Limit Appeal In US (Law360-$)
  • GSK proposes biopreparedness unit to combat global outbreaks (Pharmafile)
  • FDA, EMA, PMDA Begin Push for New Antibacterials (Focus)
  • Mistrust of vaccines is greatest in France: survey (Reuters)
  • These Blood Suckers Cost $2.5 Billion to $138 Billion Each Year (Forbes)
  • Pfizer launches legal action to block Xeljanz copies in India (Pharmafile)
  • NICE green light for Merck's hepatitis C drug Zepatier (PharmaTimes) (BioCentury)
  • South Africa's expedited registration policy for rapid access to critical medicines under threat by generics (GaBI)
  • Indonesian Patent Changes Favor Generics As Country Builds Up Domestic Industry (Pink Sheet-$)
  • Ivory Coast re-opens western borders closed during Ebola epidemic (Reuters)

US: Pharmaceuticals & Biotechnology

  • Gilead appoints former Roche executive (Pharmafile)
  • 'Trojan Horse' Might Take Ebola by Surprise (Medpage)
  • Court: Apotex biosimilars don't infringe Amgen patent (BioCentury)
  • How FDA is driving interest in patient engagement (MedCityNews)
  • No advisory panel for Clovis' rucaparib (BioCentury) (Fierce)
  • Vanda Petitions FDA to Not Approve Fanapt Generics Before May 2019 (Petition)
  • Tokai considers sale, reverse merger after PhIII failure; shares jump (Fierce)
  • Cancer Survivorship Is On The Rise -- And That's Both Good News And Bad (Forbes)
  • Immuno-oncology CRO expands following record year (Manufacturing Chemist Pharma)
  • Excipient Database Should Help Take Mystery Out Of ICH Q3D Risk Assessments (Pink Sheet-$)
  • Why AZ Respiratory Head Believes Third-Placed Benralizumab Can Conquer Market (SCRIP-$)
  • Bluebird Improves Its Gene Therapy, Removing an Investor Concern (The Street)

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

  • Orphan Drug Designation Granted to Nintedanib for Treatment of Systemic Sclerosis, including Associated Interstitial Lung Disease (Press)
  • More Respimat data from Boehringer (MassDevice)
  • GTx gains on Phase II breast cancer milestone (BioCentury)
  • Ovid Therapeutics Receives Orphan Drug Designation from the U.S. FDA for OV101 for the Treatment of Patients with Angelman Syndrome (Press)
  • Heron Therapeutics Announces Presentations of Results from Phase 2 Clinical Trial of HTX-011 in Hernia Repair at PAINWeek® 2016 (Press)
  • Medivir: Interim Results from Phase IIa Trial Evaluating Triple Combination Including Simeprevir Demonstrates High Level of Efficacy in HCV Patients (Press)
  • Dechra Receives FDA Approval for First U.S. Generic Entrant Antibiotic (Press)

US: Medical Devices

  • Abbott, Alere to mediate merger dispute (MassDevice) (Crain's)
  • Takeda looks to wearables for IBD patients (MassDevice)
  • Carestream wins FDA clearance for extremities CT scanner (MassDevice)
  • Class 1 Device Recall Advance(R) Ii Modular Tibial Base W/Screwholes (FDA)
  • SyntheticMR AB: MAGiC Receives FDA Approval (Press)
  • FDA clears Additive Orthopaedics' 3D-printed osteotomy wedge  (MassDevice)
  • biom'up announced enrollment of first patient in clinical investigation of HEMOBLAST Bellows (MassDevice)
  • Monteris Medical wins FDA IDE nod for another Neurablate brain cancer trial (MassDevice)

US: Assorted & Government

  • Put Up or Pay Up: Mentor Obtape MDL Judge Promises Sanctions to Plaintiff Attorneys Filing Meritless Cases (Drug and Device Law)
  • UCB, Inc. v. Yeda Research and Development Co. (Fed. Cir. 2016) (Patent Docs)
  • How Many Federal Agencies Does it Take to Interpret the Industrial Hemp Law? USDA/DEA/FDA Weigh in on Industrial Hemp Research Requirements (FDA Law Blog)
  • CMS says 'pick your pace' in 2017 MACRA payment program (MedCityNews)

Upcoming Meetings & Events


  • Neuravi wins CE Mark for EmboTrap II stent retriever (MassDevice)
  • Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 6-8 September 2016 (EMA)


  • Indian Panel Revises Bharat Vaccine Approval Amid 'Objections' (Pink Sheet-$)
  • States sit on funds while mosquito-borne diseases wreak havoc (Times of India)


  • Guidance Document Questions and Answers: Plain Language Labelling Regulations (Health Canada)
  • Consultation on the regulation of self-care products (Health Canada)

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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