GSK completes divestment of thrombosis brands and related manufacturing site to Aspen
GlaxoSmithKline (“GSK”) today completed the previously announced divestment of its thrombosis brands, ArixtraTM and FraxiparineTM to the Aspen Group (Aspen) for £700 million. (Source: GSK news)
Source: GSK news - December 31, 2013 Category: Pharmaceuticals Source Type: news
GSK Cervarix® two-dose schedule receives European marketing authorisation
GlaxoSmithKline (GSK) announced today that the European Commission has granted marketing authorisation for its cervical cancer vaccine Cervarix® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant]. (Source: GSK news)
Source: GSK news - December 20, 2013 Category: Pharmaceuticals Source Type: news
GSK and MMV announce FDA Breakthrough Therapy designation for tafenoquine for Plasmodium vivax malaria
GlaxoSmithKline (GSK) and Medicines for Malaria Venture (MMV) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for tafenoquine. (Source: GSK news)
Source: GSK news - December 20, 2013 Category: Pharmaceuticals Source Type: news
ANORO™ ELLIPTA™ approved as first once-daily dual bronchodilator for the treatment of COPD in the US
GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the US Food and Drug Administration (FDA) has approved ANORO™ ELLIPTA™. (Source: GSK news)
Source: GSK news - December 18, 2013 Category: Pharmaceuticals Source Type: news
GSK announces $1 million innovation prize for bioelectronics research
GSK is announcing today a $1 million dollar prize for innovation in the emerging area of bioelectronics research. (Source: GSK news)
Source: GSK news - December 18, 2013 Category: Pharmaceuticals Source Type: news
Update on Patent Ruling on ViiV Healthcare's EPZICOM® and TRIZIVIR®
GSK and ViiV Healthcare confirmed today that the US District Court for the District of Delaware upheld the validity of a patent covering the double combination of lamivudine and abacavir (Epzicom®) and the triple combination of lamivudine, abacavir and zidovudine (Trizivir®). (Source: GSK news)
Source: GSK news - December 18, 2013 Category: Pharmaceuticals Source Type: news
GSK and Genmab Receive Priority Review from FDA for Arzerra® (ofatumumab) as 1st Line Treatment for Chronic Lymphocytic Leukaemia (CLL)
GlaxoSmithKline plc (LSE: GSK) and Genmab A/S (OMX: GEN) announced today that the US Food and Drug Administration (FDA) has granted Priority Review designation to the supplemental Biologics License Application (sBLA) for the use of Arzerra® (ofatumumab) in combination with an alkylator-based therapy, to be used for treatment of CLL patients who have not received prior treatment and are inappropriate for fludarabine-based therapy. (Source: GSK news)
Source: GSK news - December 17, 2013 Category: Pharmaceuticals Source Type: news
GSK announces changes to its global sales and marketing practices to further ensure patient interests come first
GSK today set out plans to evolve the way it sells and markets its products to healthcare professionals to further align the company’s activities with the interests of patients. (Source: GSK news)
Source: GSK news - December 17, 2013 Category: Pharmaceuticals Source Type: news
GSK initiates voluntary open offer to increase stake in its pharmaceuticals subsidiary in India
GlaxoSmithKline (GSK) (LSE: GSK) today announced a Voluntary Open Offer (the “Offer”) to increase its stake in its publicly-listed pharmaceuticals subsidiary in India. (Source: GSK news)
Source: GSK news - December 16, 2013 Category: Pharmaceuticals Source Type: news
GSK announces £200 million investment in UK advanced manufacturing and science
GSK today announced a series of investments totalling approximately £200 million which will support the delivery of the company’s pipeline of new medicines and create a centre for pharmaceutical manufacturing innovation in the UK. (Source: GSK news)
Source: GSK news - December 11, 2013 Category: Pharmaceuticals Source Type: news
GSK and Theravance announce positive results from pivotal phase III study for fluticasone furoate/vilanterol in asthma
GlaxoSmithKline (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced positive results from a phase III efficacy and safety study of fluticasone furoate “FF”/vilanterol “VI”. (Source: GSK news)
Source: GSK news - December 6, 2013 Category: Pharmaceuticals Source Type: news
Update regarding 2010 Nature Medicine study
A GSK research paper published in 2010 that was found earlier this year to contain incorrect data has now been retracted by Nature Medicine. (Source: GSK news)
Source: GSK news - December 6, 2013 Category: Pharmaceuticals Source Type: news
GSK launches global consortium with six renowned cancer research centres
GlaxoSmithKline plc [LSE/NYSE: GSK] announced today the formation of the Oncology Clinical and Translational Consortium (OCTC) (Source: GSK news)
Source: GSK news - December 5, 2013 Category: Pharmaceuticals Source Type: news
Synflorix™ receives European marketing authorisation for additional pneumonia indication
GlaxoSmithKline (GSK) today announced that the European Commission (EC) has granted marketing authorisation for an additional indication for Synflorix™. (Source: GSK news)
Source: GSK news - December 5, 2013 Category: Pharmaceuticals Source Type: news
Regulatory Update - GSK receives positive CHMP opinion for Cervarix™ two-dose schedule
Today, GlaxoSmithKline plc (GSK) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is recommending marketing authorisation for a two-dose schedule in 9-14 year old girls for its cervical cancer vaccine, Cervarix™ [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant]. (Source: GSK news)
Source: GSK news - November 28, 2013 Category: Pharmaceuticals Source Type: news
