Regulatory Focus™ > News Articles > Regulatory Recon: FDA Tries to Dodge Free Speech Case (9 June 2015)

Regulatory Recon: FDA Tries to Dodge Free Speech Case (9 June 2015)

Posted 09 June 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA Tries to Dodge Free Speech Case (9 June 2015)

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

In Focus: US

  • FDA Looks To Placate Amarin, Duck Free Speech Decision (Law 360-$)
  • FDA’s high bar for breakthrough therapy designations (EP Vantage)
  • FDA Warned Drugmaker About Pain Pill Injection (TIME)
  • How Much of a Drug Is Safe for Preemies? (WSJ-$)
  • FDA Weighs Target Population for Amgen Cholesterol Drug Repatha (AP) (Fierce) (Tarius) (Pink Sheet-$) (SCRIP-$) (BioCentury) (MedPage Today)
  • Overall Medical Device Recalls Inched Up In 2014; High-Risk Class I's Flat (Gray Sheet-$)

In Focus: International

US: Pharmaceuticals and Biotechnology

  • FDA Looks To Placate Amarin, Duck Free Speech Decision (Law 360-$)
  • FDA’s high bar for breakthrough therapy designations (EP Vantage)
  • FDA Warned Drugmaker About Pain Pill Injection (TIME)
  • How Much of a Drug Is Safe for Preemies? (WSJ-$)
  • FDA Weighs Target Population for Amgen Cholesterol Drug Repatha (AP) (Fierce) (Tarius) (Pink Sheet-$) (SCRIP-$) (BioCentury) (MedPage Today)
  • ‘Right to Try’ Movement Wants Terminally Ill to Get Experimental Drugs (Healthline)
  • Compounders Seeking Intervention to Stop Proposed MOU (IHP-$)
  • Merck is Accused of Stonewalling Over Effectiveness of Mumps Vaccine (Pharmalot)
  • Pediatricians Upset OTC Cough/Cold Drug Label Revamp Off FDA's Radar (IHP-$)
  • The Limits of FDA's Biosimilar Naming Policy (DrugWonks)
  • Pfizer Report Warns of Possible Zoloft and Birth Defect Link (Bloomberg)
  • Brutal honesty in drug marketing? For obesity meds, it's key to avoiding the 'magic pill' trap (Fierce)
  • Mylan is Expanding its Voluntary Nationwide Recall of Select Lots of Injectable Products Due to the Presence of Particulate Matter (FDA)

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

  • Sanofi's diabetes hopeful Lyxumia gets a raft of good safety grades (Fierce) (Reuters) (Reuters) (Pink Sheet-$)
  • Giant Study Boosts Januvia, Merck's $6 Billion Drug (Forbes) (Pink Sheet-$) (Press)
  • Repros Announces Date of FDA Advisory Committee Review of NDA (Press)
  • Severe Depression Vanished In Four New Mothers After They Took This Drug. Is It For Real? (Forbes)
  • Titan plans 2nd half Probuphine resubmission on new data (SCRIP-$)
  • FDA places partial clinical hold on Neurocrine's NBI-77860 (BioCentury)
  • New Data Show Superiority of Lilly's Once-Weekly Trulicity (dulaglutide) to Lantus (insulin glargine) in Patients with Type 2 Diabetes (Press)
  • Aimmune reports Phase II peanut allergy data (BioCentury)
  • FDA approves mid-stage trial of vaccine to reverse type 1 diabetes (Reuters)
  • Braeburn Pharmaceuticals: Positive Results From Phase 3 Opioid Addiction Study (Press)
  • FDA Grants Orphan Status for ATX-F8-117 for the Treatment of Haemophilia A Patients in the US (Press)
  • AM-Pharma Receives FDA and EMA Orphan Drug Designation to Treat Hypophosphatasia (Press)

US: Pharmaceuticals and Biotechnology: General

  • PointCross announces SaaS offerings on the cloud to span the entire lifecycle of eData submissions to FDA (Press)
  • Big Pharma seeks special trade deal (Politico)
  • Georgia can't explain cloudy execution drug (PharmPro)

US: Medical Devices

  • Overall Medical Device Recalls Inched Up In 2014; High-Risk Class I's Flat (Gray Sheet-$)
  • FDA: Oversight of LDTs will facilitate adoption of pharmacogenetic testing into routine clinical care (PubMed)
  • Houston’s Medical Informatics Gets FDA Nod for Alert System Software (Xconomy)
  • Apple injects new features into HealthKit, Watch (mHealthNews) (The Verge) (Forbes)
  • Oculus Gets FDA Clearance For Novel Atopic Dermatitis Dermatology Product (RTT)
  • Class 1 Recall: Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology (FDA)
  • Class 1 Recall: Flowi Anesthesia System (FDA)
  • Class 1 Recall: HeartWare Ventricular Assist System (FDA)

Upcoming Meetings and Events

Europe

  • EMA calls for 'stakeholder' input on design of new clinical trials database (Outsourcing Pharma) (EMA) (EMA)
  • NICE clears Xolair for hives (SCRIP-$) (PharmaTimes)
  • UK pharma rebate payment doubles in one year (PMLive) (Pharmafile)
  • Pfizer apologizes to U.K. docs as Lyrica protection campaign hits snag (Fierce)
  • Accelerated Access to innovation on the NHS – can it be achieved? (PharmaPhorum)
  • Firms join in new IMI adaptive pathways project (SCRIP-$)

India

  • India's Sun says slow and steady on Ranbaxy plants, FDA on Wockhardt at odds with management (Fierce)
  • GSK, Sanofi hauled up by India's competition watchdog on vaccine tenders (Fierce) (India Times)

China

  • GSK investigator freed from Chinese jail (Guardian)

Other International

  • Playing to Win in the Global Biosimilars Environment (Deloitte)
  • Transparency International Addresses “Corruption in the Pharmaceuticals and Healthcare Sector” (Policy and Medicine)

Clinical Trials

  • Novartis' Signature speeds up clinical trials (SCRIP-$)

General Regulatory And Interesting Articles

  • One-Third of World Population Suffers From More Than Five Illnesses (MPR)
  • Why Do Medical Device Businesses Fear Modern Electronic Documentation? (MDO)

Regulatory Reconnaissance #572 – 9 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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe