GlaxoSmithKline (GSK) and Danish biotechnology firm Genmab have filed a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for the use of its leukaemia drug Arzerra (ofatumumab) in combination ...
Tags: GlaxoSmithKline, CLL Patients
c Gonal-f RFF Redi-ject is a disposable pre-filled drug injector pen intended for the subcutaneous injection of a liquid formulation of Gonal-f RFF (revised formulation female). The fertility pen has been redesigned to incorporate the ...
Tags: Fertility Pen, EMD Serono
Pfizer has secured European Commission approval to carry out updates to the summary of product characteristics (SmPC) for its pneumococcal conjugate vaccine (PCV) Prevenar 13, regarding its use in certain high-risk populations. Now the ...
Tags: Pfizer, Label Update
Collegium Pharmaceutical, a specialty pharmaceutical company, has announced that a patent has been issued by the US Patent and Trademark Office (USPTO) covering its Oxycodone DETERx formulation. Additionally, an application has been ...
AGC Chemicals, a subsidiary of Asahi Glass, has introduced the new AG-E070 to its line of AsahiGuard E-SERIES fluoropolymers for sizing in food contact paper, paperboard and pulp molding applications. The product has been designed to ...
Tags: AGC Chemicals, Food Contact Paper
CardioFocus, developer of the HeartLight endoscopic ablation system (EAS) for the treatment of atrial fibrillation (AF), has concluded enrollment of its US pivotal trial evaluating the HeartLight system, for the treatment of symptomatic ...
Amarin, a biopharmaceutical company, has announced the outcome of the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee for the use of Vascepa (icosapent ethyl) capsules in the treatment of high ...
AMAG Pharmaceuticals has received a notice of three-month extension from the US Food and Drug Administration (FDA) for a supplemental new drug application (sNDA) for Feraheme (ferumoxytol) injection to be used for intravenous (IV) therapy. ...
Tags: AMAG Pharma, Intravenous Use
Danish pharmaceutical firm Novo Nordisk has received biologics licence application (BLA) approval from the US Food and Drug Administration (FDA) for its recombinant coagulation factor VIII, Novoeight. Novoeight is intended for adults and ...
Tags: Novo Nordisk, Drug
AGC Chemicals Americas Inc. has added AG-E070 to its line of AsahiGuard E-SERIES fluoropolymers for sizing in paper, paperboard and pulpvmolding applications. AsahiGuard AG-E070 imparts outstanding oil, grease and watervresistance in paper ...
Tags: AGC Chemicals, Paper Products
US-based Heart Imaging Technologies (Heart IT) has announced the launch of OsiriX interface for the WebPAX image management system. OsiriX is an open-source software package for advanced post-processing of medical images and is the latest ...
Johnson & Johnson (NYSE: JNJ) announced today that Mark B. McClellan, M.D., Ph.D., Senior Fellow in Economic Studies, and Director of the Initiative on Value and Innovation in Health Care, Brookings Institution, will join the Board of ...
Tags: Light Industry, Daily Use, Johnson
US-based biopharmaceutical company MannKind has resubmitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking marketing authorization for its AFREZZA inhalation powder, indicated to improve glycemic control ...
Tags: Insulin Application, biopharmaceutical company MannKind
The US Food and Drug Administration (FDA) has approved Antares Pharma's (Antares) OTREXUP, a single-dose, disposable auto-injector for the subcutaneous (SC) once-weekly administration of methotrexate (MTX). OTREXUP is reportedly the first ...
St. Jude Medical, a global medical device company, has completed the acquisition of Nanostim, a developer of miniaturized, leadless pacemakers. St. Jude Medical and Nanostim have entered into a series of agreements in May 2011, pursuant ...
Tags: St.Jude Medical, medical device