Regulatory Recon: PhRMA CEO Says FDA Review Process Should Remain the 'Gold Standard' BMS Takeover Rumors Rise After Icahn Buys Stake (22 February 2017)

Posted 22 February 2017 | By Michael Mezher 

Regulatory Recon: PhRMA CEO Says FDA Review Process Should Remain the 'Gold Standard' BMS Takeover Rumors Rise After Icahn Buys Stake (22 February 2017)

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

In Focus: US

  • FDA 'guides' the way to medical device security (CSO)
  • PhRMA CEO: 'FDA review process is the gold standard and should remain so' (STAT)
  • Trouble in drug price negotiation land (Politico)
  • Buyout buzz swells for the giant Bristol-Myers after Carl Icahn Takes Stake in Company (Forbes) (CNBC) (WSJ) (Endpoints)
  • BMS Buys Back Shares, Shuffles Board (The Street)
  • New patient group focuses on drug prices amid bipartisan concern (USA Today
  • Bad news for Momenta and Pfizer is a much-needed blessing for Teva (STAT)
  • Generic Drug Group Joins BIO, PhRMA To Oppose Maryland Transparency Bill (IHP-$)
  • Precision oncology: Charting a path forward to broader deployment of genomic profiling (PLOS)
  • Supreme Court Won't Hear $308M Boston Scientific Appeal (Law360-$) (Reuters)
  • Opinion: How Other Countries Freeload on US Drug Research (WSJ)
  • Louisiana drug and dietary supplement maker ordered to cease operations due to federal violations (FDA)
  • Senators Look to Overhaul Medical Device Inspections (Focus)
  • FDA's Pazdur and Blumenthal: The March of Checkpoint Inhibitors Will Continue (Focus)
  • FDA Defines the Scope of 3-Year Exclusivity for MORPHABOND After Wrestling With Different Approaches (FDA Law Blog)
  • A Call For The FDA To Raise The Bar For Clinical Trials Is Flawed (Forbes)
  • Capitol Hill health committee leaders defend vaccines in bipartisan letter (SNL)
  • Researchers Failed To Tell Testosterone Trial Patients They Were Anemic (NPR)

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In Focus: International

  • EMA Outlines GCP Inspection Plan for 2017 (Focus)
  • Bayer boosted by strong earnings in pharmaceutical unit (Financial Times) (Press)
  • 'Alarming' superbugs a risk to people, animals and food, EU warns (Reuters)
  • Brazil suspends and recalls Essure (Modern Healthcare)
  • China revises food, drug safety targets for 2020 (Reuters)
  • Eric Cornut appointed Interim Director General as Richard Bergström leaves EFPIA (EFPIA)
  • Interview – Chi-Med looks outside its comfort zone (EPVantage)
  • Abbott denies reports it will bail on India's high-end stent market (MassDevice)
  • Final NICE yes for Amicus' Fabry disease drug (PharmaTimes)
  • Edwards, Boston Scientific await EU court decisions in heart valve patent spats (MassDevice)
  • EMA Review Of Non-EU Drugs To Be Made More Useful For African Regulators (Pink Sheet-$)
  • Biocad and Roche continue legal battles in Russia (PharmaLetter-$)
  • CETA has potential to strengthen European manufacturing base of the generic, biosimilar sectors (PharmaLetter-$)
  • 'Non-Medical Switching' Claim Riles Europe's Biosimilars Industry (Pink Sheet-$)
  • Billions At Stake As Generic Approvals Open Up Japan Big Sellers (SCRIP-$)

US: Pharmaceuticals & Biotechnology

  • Late-stage data on Trevena's opioid painkiller irks investors (Reuters)
  • Merck, others send experiments to space to build smarter drugs on Earth (SNL)
  • Depomed Reports 33% Increase in 2016 Net Product Sales (The Street)
  • 10 Favorite New Biotechnologies of 2016 (Part II) (Biotechr)
  • Escaping the Gravitational Pull of "Druggability" (LinkedIn Pulse)
  • Behind The Blockbuster: Investors Sound Off On Biogen's Future With Spinraza (SCRIP-$)
  • A Drag On Drugs? Trump's Tariffs Could Raise Costs, Particularly For Generics (Pink Sheet-$)
  • How US Tax Plan Could Affect Global Pharma Manufacturing Networks (Pink Sheet-$)
  • Unapproved Petitioner: Clinical-Stage Firm Wants FDA Scrutiny Of Naloxone Formulations (Pink Sheet-$)
  • Gilead's hep C pain helps the rest of pharma on drug spending: analyst (Fierce)
  • Sage Therapeutics Takes Investors On A Wild Ride As CEO Talks Up Brain Drugs (Forbes)
  • The Top 15 Specialty Pharmacies of 2016 (Drug Channels)
  • Abzena to make wet-AMD antibody drug candidate for UCL at US plant (BioPharmaReporter)
  • FDA Cites Two API Makers for Data and Label Discrepancies (FDANews-$)
  • Lannett Co says FDA agreed to delay submission deadline for Methylphenidate ER tablets (Reuters)
  • Drugmaker Humco Lands Warning Letter Over GMP Deficiencies, Unapproved Drugs (FDANews-$)

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

  • Argos kidney cancer vax fails phase 3 futility review, future in doubt (Fierce) (Press)
  • Experimental PfSPZ malaria vaccine provides durable protection against multiple strains in NIH clinical trial (NIH)
  • Cidara fails phase 2 study, drops med in vulvovaginal candidiasis (Fierce) (Press)
  • VBL posts additional data from phase 2 thyroid cancer trial (Fierce) (Press)
  • After Merck KGaA rejection, Apitope advances MS drug on strength of phase 2a safety, lesion reduction data (Fierce) (Press)
  • FDA Priority Review for Pfizer investigational leukaemia drug (Pharmafile) (Fierce) (Press)
  • Ocular Therapeutix™ Announces FDA Acceptance of NDA Resubmission for DEXTENZA™ for the Treatment of Ocular Pain Occurring After Ophthalmic Surgery (Press)
  • Atreca, Inc. Presents New Preclinical Findings for Novel Cancer Immunotherapy Platform at Molecular Medicine Tri-Conference 2017 (Press)

US: Medical Devices

  • Medical device enforcement is getting more serious—particularly in Northeast (Medical Design & Outsourcing)
  • Cybersecurity firm warns of malware on medical devices (MassDevice)
  • Managing the Unpredictability of the Product Development Process (MDDI)
  • What You Need to Know: IEC 60601-1-2 4th Edition (MDDI)
  • LivaNova initiates recall of FlexTherm heater cooler devices (MassDevice)
  • Wright Medical posts Street-topping Q4, FY2016 (MassDevice)
  • Abbott floats bid to exchange St. Jude senior notes (MassDevice)
  • Fresenius guides for double-digit growth (MassDevice)
  • FDA Clears DiaSorin's C. difficile Assay (GenomeWeb)
  • BD Veritor System Meets FDA's New Performance Requirements for Rapid Influenza Antigen Detection Tests (Press)
  • Revolutionary Diagnostic SeptiCyte™ LAB Cleared By FDA for Suspected Sepsis Patients (Press)
  • Actamax seeks FDA nod for sprayable adhesion barrier trial (MassDevice)

US: Assorted & Government

  • Spoiler Alert: Florida Appellate Court Upholds PMA Preemption and Rejects Parallel Claim (Drug & Device Law)
  • Trump Administration Seeks Delay in Lawsuit Over Health-Law Subsidies (WSJ)
  • US judge blocks Texas plan to cut Planned Parenthood Medicaid funds (Reuters)
  • National Vaccine Injury Compensation Program: Revisions to Vaccine Injury Table; Delay of Effective Date (HHS)
  • High Court Declines Czech Republic Suit Over $325M Award (Law360-$)
  • Impax Says FTC Should Pay For Withdrawn Pay-For-Delay Suit (Law360-$)

Upcoming Meetings & Events


  • CareFusion expands Alaris warning (MassDevice)
  • Adapt Pharma seeks regulatory nod for naloxone nasal spray in Europe (Drug Delivery)
  • Dutch parliament votes to regulate marijuana cultivation (Reuters)
  • Cancer drug plant likely source of radio isotope detected across Europe say experts (InPharmaTechnologist)
  • Nativis bolsters boardroom with new director (Pharmafile)
  • Lysogene Receives Orphan Drug Designation from EMA for LYS-GM101 for Treatment of GM1 Gangliosidosis (Press)
  • AmpTec looking to achieve full GMP compliance for APIs (InPharmaTechnologist)


  • Akihisa Nabeshima elected new president of Teijin Pharma (PharmaLetter-$)


  • Data on US FDA observations on Indian firms disturbing: Edelweiss (Economic Times)
  • DoP directs NPPA to refix ceiling prices of phenobarbitone 30 mg tablets and sodium valprorate 200 mg tablets (Pharmafile)
  • Granules to expand Indian API plants and US dosage form site (InPharmaTechnologist)
  • NPPA warns stent makers, importers against shortage (Economic Times)


  • Summary Safety Review - Bisphosphonates - Assessing the Potential Risk of Severe Bone Damage (osteonecrosis) (Health Canada)


  • TGA Looks to Replace 'Burdensome' Requirements for Distributing Unapproved Drugs (FDANews-$)
  • Hazard Alert - Medtronic Strata II / Strata NSC valves (TGA)
  • Access to medicinal cannabis products: steps to using access schemes (TGA)
  • Hazard Alert - Biolox Forte 36 mm Alumina ceramic heads - used in hip replacements (TGA)

Other International

  • Evidence for scaling up HIV treatment in sub-Saharan Africa: A call for incorporating health system constraints (PLOS)
  • Delays and loss to follow-up before treatment of drug-resistant tuberculosis following implementation of Xpert MTB/RIF in South Africa: A retrospective cohort study (PLOS)
  • Japan negotiates with Egyptian companies to establish pharmaceutical factories in local market: ambassador (Daily News Egypt)
  • New Zealand pharmacists will soon be able to dispense OTC oral contraception (Pharmaceutical Journal)

General Health & Other Interesting Articles

  • Life expectancy study shows many likely to live beyond 90 by 2030 (Reuters)
  • Fructose tied to advanced liver disease in children and teens (Reuters)
  • When Evidence Says No, But Doctors Say Yes (ProPublica)
  • NIH-supported trials of testosterone therapy in older men report mixed results (NIH) (Reuters)
  • Exercise linked to better breast cancer outcomes (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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