Regulatory Focus™ > News Articles > Regulatory Recon: FDA Willing to Accept Data From a New Type of Cancer Trial (26 February 2015)

Regulatory Recon: FDA Willing to Accept Data From a New Type of Cancer Trial (26 February 2015)

Posted 26 February 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA Willing to Accept Data From a New Type of Cancer Trial (26 February 2015)

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

In Focus: US

  • A Faster Way to Try Many Drugs on Many Cancers (NYTimes)
  • FDA postpones key hearing on biosimilar copy of blockbuster drug (Reuters) (Pink Sheet-$) (BioCentury)
  • FDA approves Actavis' new antibacterial drug Avycaz (FDA) (Fierce) (Reuters) (BioCentury) (SCRIP-$) (Press) (PMLive)
  • India's Wockhardt says FDA raises new concerns about Waluj plant (Reuters)
  • Sanofi's diabetes drug Toujeo gets U.S. approval, label disappoints (Reuters) (Fierce) (WSJ-$) (SCRIP-$) (Press) (Bloomberg)
  • After Deadly Infections, F.D.A. Asks Device Makers About Cleaning Methods (NYTimes)
  • FDA to Hold Workshop on Robotically-Assisted Surgical Devices (FDA) (Gray Sheet-$)
  • FDA weighs in on Intuitive Surgical recall of da Vinci vessel sealer due to inadequate grasping (Fierce)
  • Olympus slapped with suits from UCLA superbug patients over endoscope devices (Fierce) (LA Daily)
  • Report: FDA Recalls Fell in Fourth Quarter of 2014 (PharmPro)

In Focus: International

  • European Commission Approves Bayer's Eylea (Press)
  • Meeting upon meeting but little progress on EU medtech, IVD regulations (SCRIP RA-$)
  • EU Health Commissioner calls for national plans to tackle rare diseases (EurActiv)
  • NICE backs biologics for ulcerative colitis (PharmaTimes) (MNT) (Press)
  • Counterfeit Drugs Flood Nigerian Market (CNBC Africa)
  • Turkish medicines verification app taking off? (Securing Industry)

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US: Pharmaceuticals and Biotechnology

  • A Faster Way to Try Many Drugs on Many Cancers (NYTimes)
  • FDA postpones key hearing on biosimilar copy of blockbuster drug (Reuters) (Pink Sheet-$) (BioCentury)
  • FDA approves Actavis' new antibacterial drug Avycaz (FDA) (Fierce) (Reuters) (BioCentury) (SCRIP-$) (Press) (PMLive)
  • India's Wockhardt says FDA raises new concerns about Waluj plant (Reuters)
  • Sanofi's diabetes drug Toujeo gets U.S. approval, label disappoints (Reuters) (Fierce) (WSJ-$) (SCRIP-$) (Press) (Bloomberg)
  • New PhRMA Report: A Decade of Innovation in Rare Diseases (PhRMA) (BIO)
  • FDA Asks for Input on Pediatic Drug Development Policies (FDA)
  • FDA Seeks Tools to Visualize Clinical and Non-Clinical Drug Application Data (FDA)
  • FDA's Rappaport Weighs in on Use of Anesthesia in Children (PubMed) (The Spectator)
  • FDA to Hold Meeting on Measuring Dystrophin in DMD Patients and Interpreting Data (FDA)
  • ANDA and 505(b)(2) NDA Proposed Rules: MMA and More (FDA Life)
  • Arkansas Compounding Pharmacy Warned by FDA (FDA)
  • South Carolina court orders Johnson & Johnson to pay $136 million in Risperdal case (Reuters) (Law 360-$) (Bloomberg)
  • Revised MAPP Covers Resubmissions of NDAs, BLAs and Efficacy Supplements After CRLs (FDA)
  • Bayer Unit Misled FDA On Birth Control, Law Firm Says (Law 360-$) (FDA)
  • Lachman Petitions FDA to Approve Generic Benicar (FDA)
  • Recall of Two IV Antibiotics Announced (MPR) (FDA)
  • Sandoz To Delay Launch Of Its Neupogen Biosimilar (Pink Sheet-$) (Law 360-$)
  • Oklahoma 'Right To Try' Measure Approved By House Committee (AP)
  • Public Notification: Lean Body Extreme contains hidden drug ingredients (FDA)

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

  • Otonomy Submits New Drug Application to the FDA for AuriPro (Press)
  • Insys Therapeutics Announces Its Pharmaceutical Cannabidiol Received Fast Track Designation From FDA for the Treatment of Dravet Syndrome (Press)
  • Antares' testosterone injection successful in late-stage study (Reuters)
  • Amgen completes PhIII trifecta as AMG416 goes head-to-head with Sensipar (Fierce) (WSJ-$)
  • Pfizer Working To Resolve Sickle Cell Drug Hold Up, Dolsten Says (Pink Sheet-$)

US: Pharmaceuticals and Biotechnology: General

  • Cancer Drug Once Bought for $7 Million May Now Fetch $18 Billion (Bloomberg)
  • High Court Won’t Hear Anti-Vaxxer’s Autism Arguments (Law 360-$)
  • Prescription Opioid Use Stable, But Patients Using Stronger Painkillers (MPR)

US: Medical Devices

  • After Deadly Infections, F.D.A. Asks Device Makers About Cleaning Methods (NYTimes)
  • FDA to Hold Workshop on Robotically-Assisted Surgical Devices (FDA) (Gray Sheet-$)
  • FDA weighs in on Intuitive Surgical recall of da Vinci vessel sealer due to inadequate grasping (Fierce)
  • Olympus slapped with suits from UCLA superbug patients over endoscope devices (Fierce) (LA Daily)
  • Is FDA Dropping the Ball When it Comes to Duodenoscopes and CRE? (CNN)
  • FDA Moves Reproduction Embryo Image Assessment System Into Class II (FDA)
  • Class I Recalls for Teleflex Humidifiers (FDA) (FDA)
  • Tattoo removal: FDA clears Cynosure's 532 nm laser system (Mass Device)

US: Dietary Supplements

  • AHPA online resource aims to help industry rebut criticisms arising from NYAG affair (NI-USA)

US: Assorted And Government

  • Report: FDA Recalls Fell in Fourth Quarter of 2014 (PharmPro)
  • More Animals Used in Lab Experiments, Study Finds (NBC) (Press)
  • Bill Would Increase Medical Preparedness, With Focus on Drugs and Devices (Congress) (2)
  • U.S. CDC warns overuse of antibiotics has fueled more infections (Reuters)
  • FDA Enforcement Report - Week of February 25, 2015 (FDA)
  • Permanent R&D tax credit bill reintroduced in Senate (BioCentury)

Upcoming Meetings

Ebola Outbreak

  • FDA approves Corgenix's Ebola test for emergency use (Reuters) (Press)
  • Six challenges to stamping out Ebola (Nature)

Europe

  • European Commission Approves Bayer's Eylea (Press)
  • Meeting upon meeting but little progress on EU medtech, IVD regulations (SCRIP RA-$)
  • Health Commissioner calls for national plans to tackle rare diseases (EurActiv)
  • NICE backs biologics for ulcerative colitis (PharmaTimes) (MNT) (Press)
  • G-BA backs J&J's Sylvant (BIoCentury)
  • EMA Transitioning to mandatory use of electronic application forms (EMA)
  • Meridian Bioscience Receives CE Marking for Two New Molecular Amplification Tests: illumigene Chlamydia and illumigene Gonorrhea (Press)
  • Tolero Pharmaceuticals Receives EMA Orphan Drug Designation for Alvocidib for the Treatment of Acute Myeloid Leukemia (Press)

India

  • Maha FDA's XLN technology to expedite disposal of applications related to sale & mfg licences (PharmaBiz)
  • Pharmexcil to push for recognition of IP standards with Vietnamese authority (PharmaBiz)

Canada

  • XEN Gel Stent Receives Approval from Health Canada to Treat Glaucoma (Press)

Australia

  • TGA's Consultation forecast (TGA)

Other International

  • Singapore clinician's PAH insight offers window on 'Dallas Buyers Club' for orphan therapies in Asia (Fierce)
  • Counterfeit Drugs Flood Nigerian Market (CNBC Africa)
  • Turkish medicines verification app taking off? (Securing Industry)
  • Saudi FDA closes 20 medical supply stores in Riyadh (Arab News)

General Regulatory And Interesting Articles

  • Brain-Altering Devices May Supplant Drugs -- And Pharma Is OK With That (Forbes)
  • The best selling prescription drugs in the world last year (Quartz)
  • Supplying medicines to refugees: a logistical nightmare (PharmJournal)
  • Four Reasons to Automate SOP Management in FDA and ISO Environments (GxP Lifeline)
  • 7 Document Management Blunders that Jeopardize Compliance (GxP Lifeline)
  • Warning on Use of Drug for Children's Sleep (DD&D)

Regulatory Reconnaissance #502 – 26 February 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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