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TXT Pay-for-delay Settlements Drop Substantially: FTC [298 Words] [ Price : $8.95]
The Federal Trade Commission says drug companies are entering into substantially fewer pay-for-delay patent dispute settlements than they were engaging in three years ago.
01/14/2016
 
 
TXT FDA Rejects Biomarin NDA for Kyndrisa [428 Words] [ Price : $8.95]
FDA issues BioMarin Pharmaceutical Inc. a complete response letter on its NDA for Kyndrisa (drisapersen) for treating Duchenne muscular dystrophy amenable to exon 51 skipping.
01/14/2016
 
 
TXT Changes Sought in Device Animal Study Guidance [254 Words] [ Price : $8.95]
Three medical device stakeholders raise many issues in an FDA draft guidance on general considerations for medical device animal studies.
01/14/2016
 
 
TXT FDA Clears NeuroMetrix Upgraded Quell Pain Device [89 Words] [ Price : $8.95]
FDA clears a NeuroMetrix 510(k) for an upgraded version of Quell, the company's over-the-counter, drug-free chronic pain relief wearable device.
01/14/2016
 
 
TXT Docket Established on Clinical Outcomes Pilot [90 Words] [ Price : $8.95]
Federal Register Notice: FDA establishes a docket to receive comments on its pilot “Clinical Outcome Assessment Compendium.”
01/13/2016
 
 
TXT FDA Seeking COA Compendium Comments [215 Words] [ Price : $8.95]
FDA seeks public comment on a pilot clinical outcome assessment compendium intended to help drug developers in patient-focused development.
01/13/2016
 
 
TXT Hospira, Celltrion Back Apotex in Biosimilar Appeal [150 Words] [ Price : $8.95]
Hospira and Celltrion ask a federal appeals court to rule that the Biologics Price Competition and Innovation Act does not require a 180-day delay to start marketing a biosimilar after FDA approval.
01/13/2016
 
 
TXT FDA Orphan Status for Five Prime Tumor Therapy [139 Words] [ Price : $8.95]
FDA grants Five Prime Therapeutics an orphan drug designation for FPA008 for treating pigmented villonodular synovitis, a locally aggressive tumor of the synovium.
01/13/2016
 
 
TXT FDA Clears Siemens Hemostasis System [107 Words] [ Price : $8.95]
FDA clears a Siemens Healthcare 510(k) for the Sysmex CS-5100 System, a hemostasis system that enables automated, standardized sample management as well as automated detection of unsuitable samples.
01/13/2016
 
 
TXT CDER Offers Online Course for Generic ‘Self Identification’ [210 Words] [ Price : $8.95]
CDER’s online learning portal, CDERLearn, adds two educational tutorials on generic drug user fee “self identification” electronic (SPL) submissions.
01/13/2016
 
 
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