Regulatory Focus™ > News Articles > Regulatory Recon: FDA Grants Early Approval to Promising New Breast Cancer Drug (4 February 2015)

Regulatory Recon: FDA Grants Early Approval to Promising New Breast Cancer Drug (4 February 2015)

Posted 04 February 2015 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Grants Early Approval to Promising New Breast Cancer Drug (4 February 2015)

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

In Focus: US

In Focus: International

  • MHRA Warns About Black Market Biologics Manufacturing (MHRA) (In the Pipeline)
  • New MHRA Guidance on Manufacturing "Specials" (MHRA)
  • Britain Votes to Allow World's First "3-Parent" IVF Babies (SciAm) (NBC) (Reuters) (AP)
  • FDA invites Indian regulators to join inspections (The Hindu)
  • FDA Working to Help Indian Counterparts Boost Regulatory Capacity (Business Today)
  • Compulsory Licensing High On China Health Regulator’s Policy Agenda (PharmAsia-$)
  • Canadian Cost Regulators Reject Alexion's Soliris (National Post)

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US: Pharmaceuticals and Biotechnology

  • Pfizer wins early FDA approval for a potential cancer blockbuster Ibrance (Fierce) (SCRIP-$) (Press) (FDA) (MedPage Today) (Reuters) (PMLive) (BioCentury) (Bloomberg)
  • FDA Hiring More Staff to Oversee India Operations (India Times) (Business Standard)
  • FDA Working to Help Indian Counterparts Boost Regulatory Capacity (Business Today)
  • How to Measure a Medical Treatment’s Potential for Harm (The Upshot) (MedCityNews)
  • FDA Expects Three Priority Review Vouchers to be Used Next Year (Pink Sheet-$)
  • FDA Breast Cancer Patient Meeting Likely To Examine Differences Between Early-Stage and Metastatic Experiences (RPM Report-$)
  • New Drug Shortages Remain Flat in 2014 (FDAnews-$)
  • FDA Drug Shortage Advice: Talk To Us Early; We’ll Be Discreet (Pink Sheet-$)
  • FDA Explains its Definition of "Drug Shortage" (FDA)
  • Global Excipient Databases Are Advancing That Will Fill Content and Functionality Gaps in Existing Regulatory Efforts and Further Industry/Regulator Communication (IPQ-$)
  • What Failed, the New Cancer Treatment or Regulators? (WSJ-$)
  • The Urban Myths of Expanded Access (DrugWonks)
  • New AfPA Video Urges Distinct Names, Comprehensive Testing for Biosimilars (IFPA)
  • 2015 Will Be A Watershed Moment For Biosimilars (Law 360-$)
  • NJ Court Backs Strict Enforcement Of Generic Drug Settlement (Law 360-$)
  • Listening to the voice that matters—The patient's (BioWorld)
  • Virginia House Passes "Right to Try" Legislation (WTVR)
  • Two More Right-to-Try Bills Introduced in Hawaii House (Compliance Expert)
  • FTC To Get 1st Solo Crack At Cephalon Pay-For-Delay Claims (Law 360-$)
  • Lawsuit: Bargain shopping allowed meningitis tragedy (Tennessean)

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

  • FDA yanks 'breakthrough' bragging rights to Merck's hep C combo (Fierce) (Press) (Bloomberg)
  • Amgen Biosimilar Rheumatoid Arthritis Therapy Shows Positive Results (WSJ-$) (BioCentury) (Press) (Fierce) (Press)
  • Genmab stock jumps after PhII cancer data raise hopes of speedy approval (Fierce) (Reuters)
  • Roche study shows Gazyva offers strong benefits as lymphoma drug  (Reuters) (Press)
  • Celtaxsys Lead Candidate Granted Orphan Designation in Cystic Fibrosis by FDA (Press)

US: Pharmaceuticals and Biotechnology: General

  • Moody's: Big Pharmas face growing patent-loss threats, but some pipelines are improving (Fierce)
  • WHO’s Recommendations to Schedule GBL and 1, 4 Butanediol under International Drug Control Treaty Would Impose Significant Regulatory Requirements on Precursor Chemicals in the United States (FDA Law Blog)
  • Profits didn't drive flu vaccine decisions: US officials (SCRIP-$) (BioPharma Reporter-$)
  • Doctors group joins fight against 'skyrocketing' drug prices (CNBC)

US: Medical Devices

  • FDA approves first tissue adhesive for internal use (FDA)
  • Shuren: Transcatheter valve therapy registry is a model for medical device innovation and surveillance (PubMed)
  • FDA Grants Pre-Market Approval for Medtronic Melody Transcatheter Pulmonary Valve (Press) (Mass Device) (MedGadget) (Gray Sheet-$) (Fierce)
  • Form 483 Issued to Wright Medical Group (SEC)
  • Senator Urges Action of FDA Regulation of Duoenoscopes (Seattle Times)
  • FDA Regulation of Laboratory-Developed Diagnostic Tests: Protect the Public, Advance the Science (JAMA)
  • FDA's Lab Test Oversight Draws Heavy Fire, Support (Law 360-$) (AMA) (AACC) (BioCentury)
  • Insulin Pump Hacker's 5 Tips To Improve Device Security (MDDI)
  • Getinge Group: Medical Systems business area reaches agreement concerning Consent Decree with U.S. Food and Drug Administration (Press)
  • DePuy Synthes Spine Announces Expanded Indication For SYNAPSE Occipital-Cervical-Thoracic (OCT) System (MedDevOnline)
  • SpineGuard Receives FDA Clearance to Market Its PediGuard Products for Minimally Invasive Surgery (MIS) (Press)
  • Class 1 Recall for two Covidien Devices (FDA) (FDA)

US: Dietary Supplements

  • Supplement Industry Fires Back at Attorney General's Report, Say it Used Inappropriate Testing Methods (NI-USA) (DSN) (NI-USA) (Forbes) (NPR)
  • FDA: Lorcaserin Found in Dietary Supplement (MPR) (FDA)
  • Making the Case for Critical FSMA Funding (FDA)

US: Assorted And Government

  • Bipartisan Policy Center Announces New FDA Modernization Initiative (BPC)
  • Administration to call for veto of tighter regs reporting rules (The Hill)
  • FDA'er Accused of Abandoning Toddler in Car to Participate in Wine Tasting (Washington Post)

Upcoming Meetings

Ebola Outbreak

  • Blood from Ebola survivors could help spur new disease treatments (Reuters)

Europe

  • MHRA Warns About Black Market Biologics Manufacturing (MHRA) (In the Pipeline)
  • New MHRA Guidance on Manufacturing "Specials" (MHRA)
  • Britain Votes to Allow World's First "3-Parent" IVF Babies (SciAm) (NBC) (Reuters) (AP)
  • Advanced Bionics Receives CE Mark Approval of Expanded MRI Compatibility for Cochlear Implants (Fierce)

India

  • FDA invites Indian regulators to join inspections (The Hindu)
  • FDA Hiring More Staff to Oversee India Operations (India Times)
  • FDA Working to Help Indian Counterparts Boost Regulatory Capacity (Business Today)
  • Improving The Quality Of Generic Drugs (Two-Four Insight)

China

  • Compulsory Licensing High On China Health Regulator’s Policy Agenda (PharmAsia-$)
  • Significant Changes Ahead for the Chinese Biologics and Biosimilars Industry (Thomson Reuters)

Canada

Other International

  • USP Programs Help Tighten Africa’s Public Health Safety Net (USP)

General Regulatory And Interesting Articles

  • Many would risk earlier death rather than take a pill (Reuters)

Regulatory Reconnaissance #486 – 4 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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