Regulatory Focus™ > News Articles > Regulatory Recon: FDA Calls on Company to Release Data on Controversial Drug (20 April 2015)

Regulatory Recon: FDA Calls on Company to Release Data on Controversial Drug (20 April 2015)

Posted 20 April 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA Calls on Company to Release Data on Controversial Drug (20 April 2015)

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

In Focus: US

  • FDA challenges Genervon to release data from controversial ALS study (Fierce) (FDA) (SCRIP-$) (Pink Sheet-$)
  • Diet drug companies spent $60 million since 2010 amid push to win FDA approval for new products (JournalSentinel) (MedPage Today) (MPT) (MPT) (MPT) (MPT) (MPT)
  • Industry split on compassionate access bill (BioCentury)
  • Why Supposedly Abuse-Proof Pills Won't Stop Opioid Overdose Deaths (Forbes)
  • Counterfeit Version of Botox Found in the United States (FDA)
  • FDA approves first-of-its-kind corneal implant to improve near vision in certain patients (FDA) (Reuters)
  • Report Questions Whether Health Apps Benefit Healthy People (NYTimes)
  • The Doctor Is Out: LabCorp to Let Consumers Order Own Tests (Bloomberg)
  • FDA Ponders Whether Homeopathy Is Medicine (NPR) (Washington Post)

In Focus: International

  • What you need to know about the EU Clinical Trial Regulation (Pharmafile)
  • EDQM seeks industry input on water for injection monograph revision (In-Pharma)
  • EC Considering Amending Medicines Authorization Procedures (EC)
  • Fast Track TPA & TPP: Implications For India’s Pharma Industry (24 Insight)
  • Indian survey on spurious drugs underway (SCRIP-$)
  • ANVISA And The SSCC Controversy (RxTrace)

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US: Pharmaceuticals and Biotechnology

  • FDA challenges Genervon to release data from controversial ALS study (Fierce) (FDA) (SCRIP-$) (Pink Sheet-$)
  • Diet drug companies spent $60 million since 2010 amid push to win FDA approval for new products (JournalSentinel) (MedPage Today) (MPT) (MPT) (MPT) (MPT) (MPT)
  • Industry split on compassionate access bill (BioCentury)
  • CDER Novel Approvals Reach 11 in 2015 (Pink Sheet-$)
  • Why Supposedly Abuse-Proof Pills Won't Stop Opioid Overdose Deaths (Forbes)
  • Counterfeit Version of Botox Found in the United States (FDA)
  • FDA approves Neupogen for treatment of patients with radiation-induced myelosuppression following a radiological/nuclear incident (FDA)
  • PhRMA’s Vision For 21st Century Marketing Would Reshape Supplemental NDAs (Pink Sheet-$)
  • FDA Should Ease Off-Label Regs Before Courts Do: PhRMA GC (Law 360-$)
  • AMERIGEN Announces Tentative Approval of Generic Bystolic (Press)
  • Glaxo Recalls Flu Vaccine Due to Potency Problem (AP)
  • Pfizer wins first U.S. trial over Zoloft birth-defect risk (Reuters)
  • Citizen Petition Asks FDA to Clarify Particulate Requirements in Injectable Products (FDAnews-$) (FDA)
  • Actavis Announces FDA Approval of Expanded Label for Botox (OnabotulinumtoxinA) for the Treatment of Upper Limb Spasticity in Adults (Press)
  • Novel Anticoagulants Need Blood Level Monitoring Measures, FDA’s Temple Says (Pink Sheet-$)
  • FDA: Topical Flurbiprofen Exposure May Be Fatal for Pets (MPR) (FDA)
  • J&J Can't Dodge $63M Verdict In Children's Motrin Case (Law 360-$)
  • IMEDS Seeking Nominations for Open Positions on the IMEDS Steering Committee and Scientific Advisory Committee - April 2015 (RUF)
  • Reed Tech Announces FDA Lot Distribution Report (LDR) Service for Manufacturers of Biologic Products (Press)
  • FDA Approves New Formulation of Minocin (minocycline) for Injection (Press)

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

  • Merck files Keytruda NDA for lung cancer with FDA (PMLive) (Pharmafile) (Press) (Reuters)
  • Merck Cancer Drug Shines Against Skin, Lung Cancer (Forbes) (Press) (WSJ-$)
  • B-MS halts Opdivo trial early on survival benefit (PharmaTimes) (Press) (Forbes) (Reuters) (Reuters)
  • Full Data on Baxter's Investigational Recombinant Treatment BAX 111 Supports Potential Role to Treat Von Willebrand Disease (Press)
  • Lilly's psoriatic arthritis drug succeeds in late-stage study (Reuters) (Press)
  • AstraZeneca's '$3B' lung cancer drug impresses in a Phase II race with Clovis (Fierce)
  • Athersys tanks as its stem cell therapy flunks a Phase II stroke trial (Fierce)
  • FDA Grants Fast Track Designation to Eiger Bio's Lonafarnib for Hepatitis Delta Virus (HDV) Infection (Press)
  • Seattle Genetics: FDA Accepts Supplemental BLA and Grants Priority Review for ADCETRIS® (Brentuximab Vedotin) in the AETHERA Setting for the Post-Transplant Consolidation Treatment of Hodgkin Lymphoma Patients at High Risk of Relapse (Press)
  • Otsuka: Results of Phase III Study of Brexpiprazole in Adult Patients with Schizophrenia Published in American Journal of Psychiatry (Press)
  • TECFIDERA (Dimethyl Fumarate) Data Reinforce Strong, Sustained Efficacy for Newly-Diagnosed MS Patients (Press)
  • Icon Bioscience Announces Pivotal Phase 3 Clinical Data Demonstrates Exceptional Efficacy of IBI-10090 in Reducing Inflammation Associated with Cataract Surgery (Press)
  • Oncolytics' Reolysin gets orphan drug designation for malignant gliomas treatment (PBR)

US: Pharmaceuticals and Biotechnology: General

  • Colorado tightens vaccine rules (The Hill)
  • Three Members of International Synthetic Drug-Trafficking Organization Arrested in Los Angeles (DOJ)
  • Why Oklahoma is using nitrogen gas as a backup to lethal injections (Vox)

US: Medical Devices

  • FDA approves first-of-its-kind corneal implant to improve near vision in certain patients (FDA) (Reuters)
  • Report Questions Whether Health Apps Benefit Healthy People (NYTimes)
  • The Doctor Is Out: LabCorp to Let Consumers Order Own Tests (Bloomberg)
  • FDA bars Stanmore Implants from U.S. market (MassDevice)
  • Thoratec Shows Real World Results with ROADMAP (MDDI) (Fierce)
  • Investors in HeartWare wary of stroke rates (EP Vantage)
  • Telehealth reimbursement language may be left off 21st Century Cures bill (Fierce)
  • Cardiovascular Systems Receives FDA Clearance for New Peripheral Diamondback Device (Press)
  • DEKA receives additional FDA clearance for the Synchro REPLA:Y family of Laser Systems, for increased power and larger spot size (Press)
  • Conventus Orthopaedics Receives FDA Clearance For PH Cage, Proximal Humerus Implant Device (Press)
  • FDA Approves Only ICD with Ultra-High Energy on the First Shock (Press)

US: Dietary Supplements

  • Supplement GMP Compliance Means Staying On Top Of Reasons For Consumer Doubt (Tan Sheet-$)
  • Organic & Natural meets with NY AG, calls to bring raw material manufacturers under 21 CFR Part 111 (NI-USA)
  • CSPI, NRDC to FDA: Strengthen GRAS Oversight (NPI)
  • Owner of Harrisburg Diet Supplement Business Charged with Selling Misbranded Drugs (DOJ)

US: Assorted And Government

  • FDA Ponders Whether Homeopathy Is Medicine (NPR) (Washington Post)
  • HRI regulatory center weekly newsletter (PWC)
  • Tobacco's 'free speech' fight may have biopharma implications (SCRIP-$)
  • FDA and FDAAA to Collaborate on Pilot Alumni Advisor Program (FDAAA)

Upcoming Meetings and Events

Ebola Outbreak

  • Inovio, GeneOne Get DARPA Grant For Ebola Biologics (PharmAsia-$)
  • WHO leadership admits failings over Ebola, promises reform (Reuters)

Europe

  • What you need to know about the EU Clinical Trial Regulation (Pharmafile)
  • EDQM seeks industry input on water for injection monograph revision (In-Pharma)
  • EC Considering Amending Medicines Authorization Procedures (EC)
  • Public consultation of the draft methodological guideline “Internal validity of non-randomised studies (NRS) on interventions” (EUnetHTA)
  • Curetis Second-gen Pneumonia Test Gets CE Mark, Set to Launch Later This Month (GenomeWeb)
  • Hansen Medical Receives CE Mark For Magellan 10Fr Robotic Catheter (Press)
  • Haemophilia Therapies: Towards An Optimised Organisation Of Care And Access To Treatment (EDQM)

India

  • Fast Track TPA & TPP: Implications For India’s Pharma Industry (24 Insight)
  • Indian survey on spurious drugs underway (SCRIP-$)
  • IPA urges DCGI to issue guidelines for specific storage temperature details on drug labels (PharmaBiz)
  • National survey on spurious & NSQ drugs to be conducted at least once in two years: Dr Jagashetty (Pharmabiz)

China

  • Animal testing hits China social media with clothesline cats (Fierce)

Canada

  • Health Canada Considers BMPEA Pharmaceutical that is ‘Not Naturally Derived’ (NPI)

Australia

  • Defining joint replacement medical devices and ancillary medical devices (TGA)
  • Joint replacement definition - regulatory amendment (TGA)

Other International

  • ANVISA And The SSCC Controversy (RxTrace)
  • Taiwan FDA unveils new list of tainted drugs (BioSpectrum)

Clinical Trials

  • A Drug Trial’s Frayed Promise (NYTimes)
  • Increasing Minority Participation in Cancer Clinical Trials (Eli Lilly)
  • Are iPhones unlocking the future of medical research? A conversation with John Wilbanks (FasterCures)
  • Irwin Schatz, 83, Rare Critic of Tuskegee Study, Is Dead (NYTimes)

General Regulatory And Interesting Articles

  • A Robot That Can Administer Your Flu Shot (Gizmodo)
  • Workers Seeking Productivity in a Pill Are Abusing A.D.H.D. Drugs (NYTimes)
  • Measles Aerosol Vaccine Works -- But Not Quite Well Enough (Forbes)
  • DARPA Sponsors New Self-Administered Pain-Free Blood Testing Tech (MedGadget)
  • College Freshmen Develop Single-Use Numbing Device To Lessen Injection Pain (MDO)
  • New Blood Test Shows Promise in Cancer Fight (NYTimes)
  • Hearing aids may slow cognitive decline tied to hearing loss (Reuters)

Regulatory Reconnaissance #539 – 20 April 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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