Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Gaucher Drug, Clears 3D-Printed Skull (20 August 2014)

Regulatory Recon: FDA Approves Gaucher Drug, Clears 3D-Printed Skull (20 August 2014)

Posted 20 August 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Approves Gaucher Drug, Clears 3D-Printed Skull (20 August 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 by 29 August 2014 to receive the lowest rate.

In Focus: US

In Focus: International

US: Pharmaceuticals and Biotechnology

  • FDA approves Sanofi’s new rare disease drug (Pharmafile) (Reuters) (FDA) (Press) (BioCentury) (Fierce) (Pharma Times) (SCRIP-$)
  • Hospira Sues FDA Over Generic Precedex Carve-Out Approval (Law 360-$) (Reuters) (WSJ-$) (MarketWatch) (Mylan) (Pink Sheet-$)
  • Drugmaker Dr Reddy's under scanner for child-resistant packaging violations (India Times)
  • FDA Master Protocol In Metastatic Breast Cancer Likely In The Works (Pink Sheet-$)
  • Another Look at Drug Safety Data (MedPage Today)
  • GPhA: Possible Opioid Packaging Reqs Could Impose REMS-Like Market Barrier For Generics (IHP-$)
  • Focus of FDA Warning Letter, Changes Name (ECA)
  • Regulatory woes: Did a 3-year FDA delay doom Dendreon’s prostate cancer drug? (BioFlash)
  • NIH to Hold Workshop on Use of Opioids in Chronic Pain (NIH)
  • Implementing the Generic Drug User Fee Act: Struggles and Successes (PharmExec)
  • 5 Takeaways from the 21st Century Cures Initiative - Thus Far (FasterCures)
  • Voice of the Patient: Peer “Ambassadors” Help Recruitment at Aegerion (Pink Sheet-$)

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

  • FDA Accepts NDA for BI’s COPD Combo (Press) (Press) (BioCentury) (SCRIP-$)
  • Eisai Submits Applications For Antiepilepsy Agent Fycompa Simultaneously In Europe And U.S. Seeking Indication Expansion As Adjunctive Treatment Of Primary Generalized Tonic-Clonic Seizures (Eisai)
  • Amicus sets sights on approval as rare disease pill clears Phase III (Fierce) (Reuters) (Forbes) (The Street)
  • Actavis Announces Positive Results In Phase 3 Antibiotic Studies (AP)
  • AMG 416 meets in second secondary hyperparathyroidism trial (BioCentury)
  • Oncothyreon reports another tecemotide failure (SCRIP-$) (BioCentury)

US: Pharmaceuticals and Biotechnology: General

  • AMD drug reimbursement pressure rising in US (SCRIP-$)
  • Drug More Powerful Than Heroin Hides In Plain Sight (Press)
  • Insulin Market Heats Up as Biosimilars and Newer Forms Emerge (Medscape)
  • More Parents Nixing Anti-Bleeding Shots for Their Newborns (SciAm) (Sci-Based Medicine)
  • Brand Rx Makers Push Trade Deal That Restricts U.S. Ability To Curb Rx Spending (IHP-$)

US: Medical Devices

  • FDA Clears 3-D Printed Facial Implant (Hartford Business) (CNET)
  • FDA Issues Draft De Novo Guidance Incorporating FDASIA Modifications (FDA Law Blog)
  • Black Hat 2014: Open Source Could Solve Medical Device Security (MDDI)
  • FDA Rips Nidek Again On Quality Control Lapses (Law 360-$) (FDA)
  • Recall for Cardiovascular Systems' Diamondback 360 Peripheral Orbital Atherectomy System (FDA) (FDA)
  • Westmed, Inc. Receives FDA Clearance for the Vibralung Acoustical Percussor (Press)
  • Cook Medical Recalls Vascular Device (Press)
  • Medical Associations Join FDA to Combat Risk of Eye Infections in Contact Lens Wearers (Press)
  • Report: Medical device tax missing revenue mark (The Hill) (Law 360-$) (AP)

US: Dietary Supplements

  • CRN Launches Member Resource for Advertising (NPI)

US: Assorted And Government

  • D.C. Circuit Court Reaffirms Attorney-Client Privilege in Internal Investigations (Policy and Medicine)
  • Former Cetero researcher hit with US FDA warning letter (Outsourcing Pharma)
  • Alcohol is still the deadliest drug in the United States, and it’s not even close (WaPo)

Ebola Outbreak

  • Ebola Fighting Robots Head To Africa (NBC)
  • Blood of Ebola Survivors Holds Therapy Potential for Sick (Bloomberg)



  • Industry Asks for Creation of Uniform Pharmaceutical Marketing Practices Law in India (PharmaBiz)
  • India changes course, calls for bar codes for mono cartons in April (In-Pharma)
  • Change in mindset key to thwart recurring integrity issues for Indian pharma during global audits (PharmaBiz)


  • CROs At Risk From China’s New Inventor Regulation? (PharmAsia-$)


  • CardiacAssist Receives Health Canada Approval for Its PROTEK Duo Veno-Venous Cannula (Press)


  • TGA to Re-review Each Surgical Mesh Product (TGA)
  • St. Jude Recalls Defibrillators Due to Use Errors (TGA)

Other International

  • Novartis hands over experimental TB drugs in antibiotic pullback (Reuters)

Clinical Trials

  • FDA Master Protocol In Metastatic Breast Cancer Likely In The Works (Pink Sheet-$)
  • Clinverse raises $9.1M to take complexities out of clinical trial payments (MedCity News)

General Regulatory And Interesting Articles

  • Peking University Implants First 3D Printed Vertebra (Forbes)

Regulatory Reconnaissance #382 – 20 August 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

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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