Regulatory Focus™ > News Articles > Regulatory Recon: Is FDA 'Basically Approving Everything' or Do the Numbers Tell a Different Tale? (

Regulatory Recon: Is FDA 'Basically Approving Everything' or Do the Numbers Tell a Different Tale? (21 August 2015)

Posted 21 August 2015 | By Michael Mezher 

Regulatory Recon: Is FDA 'Basically Approving Everything' or Do the Numbers Tell a Different Tale? (21 August 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

In Focus: US

  • Intel sets sites on personalized treatment plans with Collaborative Cancer Cloud (FierceHealthIT) (MedCityNews)
  • The FDA Is Basically Approving Everything. Here's the Data To Prove It (Forbes) (FierceBiotech) (Counterpoint by DrugWonks)
  • Doctors’ survey reveals lack of confidence in biosimilars (GaBI)
  • Narcolepsy medication modafinil is world's first safe 'smart drug' (The Guardian)
  • Welcome to the complex world of 3D-printed drugs (The Guardian)
  • Flibanserin will be "off the market within a few years" says Public Citizen Adviser (PharmaLetter-$)
  • The ‘breakthrough’ drug Jimmy Carter is taking to treat his cancer (Washington Post)
  • Regulatory watch: What drives differences in review times among CDER divisions? (Nature-$)
  • Olympus duodenoscopes linked to suspected superbug outbreak at California hospitalb (FierceMedicalDevices)

In Focus: International

  • Antibiotic research programme launched (OnMedica)
  • Novartis' Skin Cancer Therapy Approved In Europe (SCRIP-$) (DD&D)
  • EMA validates R/F/TAF MAA for the treatment of HIV-1 (EuropeanPharmaceuticalReview)
  • IQWiG finds no hint of added benefit for Xadago in Parkinson’s disease (PharmaLetter-$)
  • IQWiG assesses Boehringer's Giotrif, Newron's Xadago (BioCentury)
  • Inflectra To Be First "Substitutable" Biosimilar In Australia (SCRIP-$) (Pink Sheet-$)
  • Indian medicine, at 1/100th cost, saves Aussie's life (Economic Times)
  • Zero Ebola Cases Reported In Sierra Leone, As Epidemic Peters Out (NPR)
  • Korea Seeks New Law To Support Orphan Drugs, Ease Supply Disruptions (PharmAsiaNews)
  • Turkey Regulatory Update: Cancer Drug Supplies, Partnership Regulation (PharmAsiaNews)

US: Pharmaceuticals and Biotechnology

  • The FDA Is Basically Approving Everything. Here's the Data To Prove It (Forbes) (FierceBiotech) (Counterpoint by DrugWonks)
  • Doctors’ survey reveals lack of confidence in biosimilars (GaBI)
  • Narcolepsy medication modafinil is world's first safe 'smart drug' (The Guardian)
  • Welcome to the complex world of 3D-printed drugs (The Guardian)
  • Flibanserin will be "off the market within a few years" says Public Citizen Adviser (PharmaLetter-$)
  • The ‘breakthrough’ drug Jimmy Carter is taking to treat his cancer (Washington Post)
  • Regulatory watch: What drives differences in review times among CDER divisions? (Nature-$)
  • FDA approves Adcetris for high risk Hodkin Lymphoma patients (MNT)

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

  • Positive phase III results for candidate etanercept and infliximab biosimilars (GaBI)
  • Summit rolls DMD drug toward PhII after coming through early test (FierceBiotech)
  • Injectable liraglutide can help obese type 2 diabetics lose weight (Pharmaceutical Journal-$)
  • Allergan Resubmits sBLA for Botox to Treat Lower Limb Spasticity (FDANews-$)
  • Macrocure's CureXcell Phase III Leg Ulcer Study Futile (SCRIP-$)
  • FDA rare pediatric disease status for idebenone in Duchenne MD (PharmaLetter-$)
  • Animal Trial to Test Promising Vaccine for H1N1 (ICT)
  • Seres Therapeutics, Inc. Announces FDA Orphan Drug Designation for SER-109 for the Prevention of Recurrent Clostridium difficile Infection in Adults (Press)
  • Sarepta Therapeutics Receives Rare Pediatric Disease Designation From FDA for Eteplirsen for the Potential Treatment of Duchenne Muscular Dystrophy (Press)
  • Pfizer Announces Positive Topline Results Of Two Phase 3 Studies Of TRUMENBA (Pfizer)
  • ASLAN's bile duct cancer drug receives orphan drug status (BioSpectrum)

US: Pharmaceuticals and Biotechnology: General

  • Intel sets sites on personalized treatment plans with Collaborative Cancer Cloud (FierceHealthIT) (MedCityNews)
  • Choosing the Right Real World Drug Data (RxViewBlog)
  • From Hope to Cures: The Value of Biopharmaceutical Innovation (The Catalyst)
  • Half of all clinical trials have never reported results (AllTrials)

US: Medical Devices

  • US FDA seeks volunteers for malfunction reporting pilot program (Clinica-$) (Focus)
  • Olympus duodenoscopes linked to suspected superbug outbreak at California hospitalb (FierceMedicalDevices)
  • FSMA Accreditation of Third-Party Auditors/Certification Bodies: A Look at FDA’s Proposed User Fee Rule and Model Accreditation Standards Guidance (FDA Law Blog)
  • June 2015 PMA Approvals (FDA)
  • Boston Scientific Announces FDA Approval of Innova Vascular Self-Expanding Stent System (MedDeviceOnline) (FierceMedicalDevices)
  • Volunteers Sought By FDA For IMDRF Submission Project (Gray Sheet-$)
  • FDA Delays GUDID Deadline Due To Security Flaw (MedDeviceOnline) (Focus)
  • InVivo moves forward on spinal scaffold trial (MassDevice)
  • Is 23andMe the New Medical Device Paradigm? (MDDI)
  • Class 1 Device Recall HUDSON RCI (FDA 1, 2, 3, 4)
  • Class 1 Device Recall Alaris Medley LVP Bezel Assembly and Frame Membrane (FDA 1, 2)

US: Assorted and Government

  • AMP Alternative To FDA LDT Plan Sent To Senate; Lets Third Parties Assess High-Risk Tests (Gray Sheet-$)
  • US court blocks California city's bid to stop pot dispensary suit (Reuters)
  • Poll: Biopharma Focuses On Profits, Not Patients (SCRIP-$)
  • The 1st IPR Institution Decisions for Biosimilars (Law360-$)

Upcoming Meetings and Events              

Europe

  • Antibiotic research programme launched (OnMedica)
  • Pfizer Announces European Medicines Agency Validates Marketing Authorization Application for Ibrance (Pfizer)
  • EMA accepts MAA for multiple myeloma drug ixazomib (EuropeanPharmaceuticalReview)
  • Novartis' Skin Cancer Therapy Approved In Europe (SCRIP-$) (DD&D)
  • EMA validates R/F/TAF MAA for the treatment of HIV-1 (EuropeanPharmaceuticalReview)
  • IQWiG finds no hint of added benefit for Xadago in Parkinson’s disease (PharmaLetter-$)
  • IQWiG assesses Boehringer's Giotrif, Newron's Xadago (BioCentury)

Canada

Australia

  • Inflectra To Be First "Substitutable" Biosimilar In Australia (SCRIP-$) (Pink Sheet-$)

India

Ebola Outbreak

  • Zero Ebola Cases Reported In Sierra Leone, As Epidemic Peters Out (NPR)

Other International

  • Korea Seeks New Law To Support Orphan Drugs, Ease Supply Disruptions (PharmAsiaNews)
  • Turkey Regulatory Update: Cancer Drug Supplies, Partnership Regulation (PharmAsiaNews)
  • ASLAN's bile duct cancer drug receives orphan drug status (BioSpectrum)

General Health and Other Interesting Articles

  • Scientists discover 'obesity master switch' for burning or storing fat (MNT)

Regulatory Reconnaissance #623 – 21 August 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 @Michael_Mezher 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