Regulatory Focus™ > News Articles > Regulatory Recon: FDA Drug Approvals on Pace for a Record Year (8 September 2014)

Regulatory Recon: FDA Drug Approvals on Pace for a Record Year (8 September 2014)

Posted 08 September 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Drug Approvals on Pace for a Record Year (8 September 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register here.

In Focus: US

In Focus: International

  • EU Releases Rare Disease Strategy Implementation Report (EC)
  • EUnetHTA Recommendations on the implementation of a sustainable European network for HTA underway (EUnetHTA)
  • NICE Nod To Alexion’s Soliris May Mean Move Away From Cost Emphasis (Pink Sheet-$)
  • Undermining the European Medicines Agency’s transparency policy (BMJ)
  • Servier breaches ABPI code with late trial data disclosure (Pharma Times) (Pharmafile) (PMLive)
  • Indian Health ministry to approve clinical trial waiver to new drugs approved abroad for life threatening diseases (PharmaBiz)
  • Pharmexcil wants India to draft a policy for orphan drugs to promote its exports (PharmaBiz)

US: Pharmaceuticals and Biotechnology

  • FDA Drug Approvals Could Match 2012 Highs (Pharmalot)
  • FDA Talks Drug Safety With China, But Visas For Staff Still Elusive (Pink Sheet-$)
  • FDA approves Keryx's ferric citrate (BioCentury) (BioFlash) (SCRIP-$) (AP) (Pharma Times) (Fierce)
  • Hospira Can't Block Generic Precedex, Judge Rules (Law 360-$) (Press) (FDA Law Blog)
  • Precedex Decision Will Impact FDA's Use Code System (Law 360-$)
  • A Legal Test for Rx Labels: When a Warning for a Drug Is Changed, How Fast Must a Knock-Off Respond? (WSJ-$)
  • FDA Must Grant Depomed’s Pain Drug Exclusivity, Judge Says  (Law 360-$) (Press) (BioFlash) (FDA Law Blog)
  • FDA advisers want more data on sunscreen safety (Oncology Practice) (Tarius) (Tan Sheet-$)
  • A Common FDA Refrain: BASF, L’Oreal Sunscreen TEAs Need More Information (Tan Sheet-$)
  • Surrogate Endpoints Are Dangerous Path For New Antibiotics – JAMA Editorial (Pink Sheet-$)
  • Merck's Keytrude Approval Unusually Speedy (Forbes)
  • FDA Posts Advisory Committee Materials for Forest’s Nebivolol/Valsartan Fixed-Combination Tablets for Hypertension (Tarius) (BioCentury) (Pink Sheet-$)
  • Purdue Pharma: Abuse rates of OxyContin significantly down three years after reformulation (DSN)
  • Testosterone Makers May Have To Do CV Risk Studies, Prove Benefit For ‘Low T’ Use (Pink Sheet-$)
  • Biosimilar Patent Disputes: What Sandoz Appeal May Clarify (Law 360-$)
  • Approval and withdrawal of new antibiotics and other antiinfectives in the U.S., 1980-2009 (PubMed)
  • FDA Approves 2 New Indications for Epaned, the First and Only Enalapril Powder for Oral Solution (Press)
  • Former FDAer, Citing USP Support, Counters Push For Shared Biosimilar Names (IHP-$)
  • IDSA launches coalition for antimicrobial resistance (BioCentury)
  • FDA Seeks Orphan Drug Scientific Consultant (FDA)
  • Profiling cumulative proportional reporting ratios of drug-induced liver injury in the FDA Adverse Event Reporting System (FAERS) database (PubMed)
  • Pharmacy Creations Issues Voluntary Recall of Four Product Lots With Limited Distribution in Florida, New Jersey, New York, and Puerto Rico Due to Potential Non-Sterility (FDA)
  • New REMS Education Program Helps Increase Safe, Responsible Use of Opioid Analgesics for Pain Relief (Press)
  • When drug withdrawal is the hardest part (Boston Globe)

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

  • Hyperion stops diabetes drug development after misconduct found (Reuters) (Fierce)
  • BioCryst remains hopeful of FDA approval for its single-dose influenza drug despite mixed results (PJO)
  • AstraZeneca's self-styled 'blockbuster' benralizumab tanks in severe COPD study (Fierce) (Reuters)
  • Lilly's insulin shows superiority over Lantus but drug safety a concern (SCRIP-$)
  • Gilead Plans sNDA Filing Later in 2014 for Ambristentan and Tadalafil Combo (Press)
  • TESARO Announces Submission Of Rolapitant New Drug Application To FDA (Press)
  • Harvard Apparatus Regenerative Technology Obtains Orphan Drug Designation from U.S. Food and Drug Administration for HART-Trachea (Press)
  • No evident association between efavirenz use and suicidality was identified from a disproportionality analysis using the FAERS database (PubMed)
  • Novartis COPD drug Ultibro beats Seretide on flare-ups (Pharma Times) (Press) (PMLive)
  • Mundipharma announces results of pivotal phase III study for flutiform in paediatric asthma (Press)
  • Astellas Receives Notification from FDA of Acceptance of Filing of Isavuconazole NDA for the Treatment of Invasive Aspergillosis and Invasive Mucormycosis (Press)
  • Quadruple Dosing of Doripenem Is Safe in Patients With CF (Medscape)

US: Pharmaceuticals and Biotechnology: General

  • The Sovaldi Anniversary? Burgess Wants Part D Milestone To Change How Gov’t Values Rx Spending (Pink Sheet-$)
  • Access  to Medical Innovation Obstacles               & Opportunities (CMPI-PDF)
  • Foreign patent abusers undermine U.S. drug industry (Detroit News)
  • Lilly Backs Lawsuit Against CMS Over its Alzheimer’s Diagnostic Drug (Pharmalot)
  • Bristol-Myers sues Merck over U.S. immunotherapy patent (Reuters) (Pharmafile)
  • SCRIP Capitol Capsule (SCRIP-$)

US: Medical Devices

  • FDA allows marketing of the first test to assess risk of developing acute kidney injury (FDA) (Gray Sheet-$) (MedCity News)
  • Lab Groups’ LDT Comments Will Highlight Barriers To Test Accessibility (Pink Sheet-$)
  • J&J loses $3.3M verdict in pelvic mesh injury lawsuit (Mass Device) (Law 360-$)
  • FDA 510(k) clearance for PROTEK Duo (TMD)
  • FDA Wants to Study Patient Matched Cutting Guides for Joint Preparation (FDA)

US: Dietary Supplements

  • NPA’s Fabricant on liver injury data: ‘FDA has not been shy about acting on issues on hepatotoxicity’ (NI-USA) (NPI)
  • Energy Drinks in the Courtroom (NPI)

US: Assorted And Government

  • FDA's Taylor joins Greenleaf (BioCentury)
  • Questions raised about mental health studies on baby monkeys at NIH labs (CBS)

Upcoming Meetings

Ebola Outbreak

  • How Fujifilm Came to the Ebola Fight (New Yorker)
  • Two Vaccines to Protect Against Ebola Could Be Available Within Weeks (NYTimes)
  • China to manufacture Ebola treatment (BioCentury)
  • Drug and vaccine makers in race against Ebola (Reuters)
  • WHO: Use Ebola survivors' blood to treat patients (AP) (Forbes) (Reuters) (NPR) (SCRIP-$)
  • Experimental Ebola vaccine protects monkeys for 10 months (Reuters) (SCRIP-$)
  • Hemispherx to test drugs against Ebola (Reuters) (Press)
  • Ebola and the Return of Quarantine (Harvard BOH)
  • How Ebola is stealing attention from illnesses that kill more people (WaPo)

Europe

  • EU Releases Rare Disease Strategy Implementation Report (EC)
  • EUnetHTA Recommendations on the implementation of a sustainable European network for HTA underway (EUnetHTA)
  • NICE Nod To Alexion’s Soliris May Mean Move Away From Cost Emphasis (Pink Sheet-$)
  • Undermining the European Medicines Agency’s transparency policy (BMJ)
  • Servier breaches ABPI code with late trial data disclosure (Pharma Times) (Pharmafile) (PMLive)
  • Mylan, Prosonix Use In Vitro Data To File Generic Fluticasone Inhaler In EU (Pink Sheet-$)
  • Roche’s RoActemra gains EU approval for use in early RA (Pharma Letter-$) (Press) (Reuters)
  • Plan to use apps/social media for drug safety information (OnMedica) (Pharmafile)
  • Medtronic receives CE mark for upgraded CoreValve TAVR (Fierce)
  • Carmat fits a second patient with its artificial heart (Reuters)
  • BI's Spiriva Files for New Indication in EU (Press) (PharmaTimes)
  • Cost a focus as GSK takes lead in new wave of biotech lung drugs (Reuters)

India

  • Health ministry to approve clinical trial waiver to new drugs approved abroad for life threatening diseases (PharmaBiz)
  • Pharmexcil wants Centre to draft a policy for orphan drugs to promote its exports (PharmaBiz)
  • DCGI orders Nichi-In to stop sale of Dendriatic cell cancer vaccine in name of Dendriatic cell immunotherapy (PharmaBiz)

China

  • China Readies New Biosimilar Guidelines (PharmAsia-$)

Japan

  • Alexion's Asfotase Alfa Granted Orphan Drug Designation in Japan (Press)

Canada

  • Canadian shortage of vital bladder cancer drug prompts rationing (Globe and Mail)

Other International

  • Gilead to offer cheap Sovaldi to 80 countries (Fierce)
  • DePuy's Codman Neuro expands in Asia Pacific with new approvals (Mass Device) (Press)
  • Iran to unveil 12 more biological drugs by March 2015: official (Tehran Times)

General Regulatory And Interesting Articles

  • Banked blood grows stiffer with age, study finds (Press)
  • Drug-induced adverse reactions via breastfeeding: a descriptive study in the French Pharmacovigilance Database (EJCP)
  • Creating Sustainable Compliance Frameworks: Organizational implications (PCM)
  • E-nose detects asthma in children (Pharma Times)

Regulatory Reconnaissance #394 – 8 September 2014

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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