Regulatory Focus™ > News Articles > Regulatory Recon: US Adopts New Drug Stances in Pacific Trade Talks (10 June 2015)

Regulatory Recon: US Adopts New Drug Stances in Pacific Trade Talks (10 June 2015)

Posted 10 June 2015 | By Alexander Gaffney, RAC

Regulatory Recon: US Adopts New Drug Stances in Pacific Trade Talks (10 June 2015)

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

In Focus: US

  • US Shifts Stance on Drug Pricing in Pacific Trade Pact Talks, Document Reveals (NYTimes)
  • FDA Panel Backs Cholesterol Drug Praluent, but Raises Concerns (WSJ-$) (Fierce) (Forbes) (Reuters) (NYTimes) (Press) (MedPage Today) (SCRIP-$) (BioCentury) (Pink Sheet-$) (Tarius)
  • FDA Tries to Blunt Amarin’s Free-Speech Lawsuit Over Off-Label Info (Pharmalot) (Reuters)
  • Patient Groups Send Letter To FDA Expressing Concern Over Diminished Safety Standards For Biosimilars (PBSA)
  • FDA's Specialty Drug Approvals on an Upward Trajectory (PwC) (Full Report)
  • Merck and Samsung Bioepis Announce Pivotal Phase 3 Studies for Investigational Biosimilars SB4, Enbrel (Etanercept), and SB2, Remicade (Infliximab), Met Primary Endpoints (Press)
  • Cohera Medical’s Sylys Sealant Selected For FDA 'Expedited Access' (Gray Sheet-$) (Fierce)
  • What issues draw the most attention in FDA medical device inspections? (MedCityNews)
  • Federal Courts Erroneously Continue to Claim that FDA Only Spends 20 Hours On Average Reviewing 510(k)s (FDA Law Blog)

In Focus: International

  • EMA Guideline on acute heart failure drug trials (EMA)
  • MHRA asking for feedback on how it communicates medicines safety issues (MHRA)
  • Year Before Europe’s New Clinical Trials Regulation Take Effect, Pharma Companies Must Prepare For A Tough Compliance Challenge (PCM)
  • Industry warns new UK market access office will address only part of problem (Clinica-$)
  • Medical Device Licensing and Approval in Canada (Emergo)

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US: Pharmaceuticals and Biotechnology

  • U.S. Shifts Stance on Drug Pricing in Pacific Trade Pact Talks, Document Reveals (NYTimes)
  • FDA Panel Backs Cholesterol Drug Praluent, but Raises Concerns (WSJ-$) (Fierce) (Forbes) (Reuters) (NYTimes) (Press) (MedPage Today) (SCRIP-$) (BioCentury) (Pink Sheet-$) (Tarius)
  • FDA Tries to Blunt Amarin’s Free-Speech Lawsuit Over Off-Label Info (Pharmalot) (Reuters)
  • Patient Groups Send Letter To FDA Expressing Concern Over Diminished Safety Standards For Biosimilars (PBSA)
  • FDA's Specialty Drug Approvals on an Upward Trajectory (PwC) (Full Report)
  • GSK asthma medication to go before FDA panel Thursday (MM&M) (Tarius)
  • FDA Advisory Committee Gives Input on Communicating the Fetal Effects of Methadone or Buprenorphine for Opioid Addiction (Tarius)
  • Celltrion's Biosimilar User Fee Deadline Passes With Conspicuous Silence (Pink Sheet-$)
  • FDA Says Baxter's Zofran (Ondansetron) Withdrawn for Safety, Efficacy Reasons (FDA) (FDA)
  • OMB Signs off on FDA Plan to Study Drug Pricing in Ads (FDA)
  • FDA Re-opens Comment Period on Animal Drug Bioequivalence Document (FDA)

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

  • Merck and Samsung Bioepis Announce Pivotal Phase 3 Studies for Investigational Biosimilars SB4, Enbrel (Etanercept), and SB2, Remicade (Infliximab), Met Primary Endpoints (Press)
  • Data supports switching to Hospira biosimilar for RA (Pharmafile) (Biosimilar News)
  • Roche receives U.S. FDA breakthrough therapy designation for ACTEMRA/RoACTEMRA in systemic sclerosis, and will present new study results at EULAR 2015 (Press)
  • OncoGenex Says FDA Agrees With Phase 3 AFFINITY Protocol Amendment (Press)
  • Aripiprazole Lauroxil Phase 3 Schizophrenia Study Results Published in Journal of Clinical Psychiatry (Press)
  • NIH's RAC wants delayed bluebird trial (BioCentury)
  • Lilly and Incyte unveil detailed data on two pivotal studies of baricitinib in rheumatoid arthritis (Press)
  • FDA Awards Isarna Orphan Drug Designation for ISTH0036 to Improve Glaucoma Treatment Outcome (Press)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • Cohera Medical’s Sylys Sealant Selected For FDA 'Expedited Access' (Gray Sheet-$) (Fierce)
  • What issues draw the most attention in FDA medical device inspections? (MedCityNews)
  • Federal Courts Erroneously Continue to Claim that FDA Only Spends 20 Hours On Average Reviewing 510(k)s (FDA Law Blog)
  • Wave of PMAs comes amid May’s overall dry spell (Clinica-$)
  • HeartWare tells patients how to safely use its blood pump in attempt to overcome slew of recent recalls (Fierce)
  • 2nd Circ. Boots Medtronic Infuse Suit For Overstepping FDA (Law 360-$)
  • ASAN Letter to FDA Calling for Ban on Electric Skin Shock Devices (Press)
  • Take this app and I'll call you in the morning (CNBC)
  • Classification: When “Equivalence” Means “Safety” (D&D Law)
  • Hysterectomy Device Will Be Covered by Insurer Despite Danger of Uterine Cancer’s Spread (WSJ-$)
  • FDA Approves New Cognivue System To Detect Dementia (Gray Sheet-$)

US: Dietary Supplements

  • FDA Extends Comment Period on Heomeopathy Revamp (FDA)
  • Industry opposes Durbin/Blumenthal amendments to limit military access to dietary supplements (NI-USA)

US: Assorted And Government

  • New Bill Would Require Regulatory Agencies to Specifically Consider Small Businesses (Senate)
  • Combination Products Progressing in Fits and Starts (MedDeviceSummit)

Upcoming Meetings and Events

Europe

  • Guideline on clinical investigation of medicinal products for the treatment of acute heart failure (EMA)
  • MHRA asking for feedback on how it communicates medicines safety issues (MHRA)
  • Year Before Europe’s New Clinical Trials Regulation Take Effect, Pharma Companies Must Prepare For A Tough Compliance Challenge (PCM)
  • Industry warns new UK market access office will address only part of problem (Clinica-$)
  • NICE turns down Celgene's Otezla for psoriasis (PharmaTimes)
  • Paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure (EMA)
  • June Raine on the rise of pharmacovigiliance and risk management (SCRIP-$)
  • Drug Makers Price Medicines Unfairly, U.K. Patient Groups Say (Pharmalot)
  • Public consultation of the Draft Project Plan on “Endovascular therapy using mechanical thrombectomy devices for acute ischaemic stroke” (EUnetHTA)
  • LENSAR Receives CE Mark for Five New Performance Application Upgrades to the LENSAR Laser System (Press)

Canada

  • Medical Device Licensing and Approval in Canada (Emergo)

Australia

  • TGA key performance indicators and measures: Regulator Performance Framework (TGA)

Other International

  • Regulators discuss "critical issues" in dementia R&D at Rome meeting (SCRIP-$)

General Regulatory And Interesting Articles

  • Half of all basic life science research is seriously flawed. Here’s why you should care. (WaPo) (NPR)
  • New Powered Legs Make Walking As Easy As Thinking (NBC)
  • Vaccine Kicked Rotavirus To The Curb In A Few Short Years (Forbes)
  • Gastric Reflux Drugs Linked to Heart Attacks (NYTimes)

Regulatory Reconnaissance #573 – 10 June 2015

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 @AlecGaffney 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.


Categories: Recon, Regulatory News

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