GSK Responds to FDA Decision on Avandia (rosiglitazone)
GSK plc [LSE/NYSE: GSK] announced today that the U.S. Food and Drug Administration (FDA) has eased restrictions on patient access to Avandia (rosiglitazone), following an FDA Advisory Committee review in June 2013. (Source: GSK news)
Source: GSK news - November 25, 2013 Category: Pharmaceuticals Source Type: news
H5N1 vaccine approved by the U.S. FDA as pandemic influenza preparedness measure
GlaxoSmithKline plc (LSE/NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved its pandemic Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (also referred to as Q-Pan H5N1 influenza vaccine) for the immunisation of adults 18 and older for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine. (Source: GSK news)
Source: GSK news - November 25, 2013 Category: Pharmaceuticals Source Type: news
Tivicay® (dolutegravir) receives positive CHMP opinion in Europe for the treatment of HIV
ViiV Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Tivicay® (dolutegravir). (Source: GSK news)
Source: GSK news - November 22, 2013 Category: Pharmaceuticals Source Type: news
Further information in respect of an offering of shares of Aspen Pharmacare Holdings Limited
This press release is not intended for US residents. (Source: GSK news)
Source: GSK news - November 20, 2013 Category: Pharmaceuticals Source Type: news
GSK and Amicus Therapeutics announce revised Fabry agreement
GlaxoSmithKline (GSK) and Amicus Therapeutics (Nasdaq: FOLD) today announced that Amicus has obtained global rights to develop and commercialise the investigational pharmacological chaperone migalastat HCl as a monotherapy and in combination with enzyme replacement therapy (ERT) for Fabry disease. (Source: GSK news)
Source: GSK news - November 20, 2013 Category: Pharmaceuticals Source Type: news
Information in respect of an offering of shares of Aspen Pharmacare Holdings Limited
This press release is not intended for US residents. (Source: GSK news)
Source: GSK news - November 19, 2013 Category: Pharmaceuticals Source Type: news
RELVAR® ELLIPTA® receives European marketing authorisation for the treatment of asthma and COPD
GlaxoSmithKline plc (GSK) and Theravance, Inc. (NASDAQ: THRX) announced today that the European Commission has granted marketing authorisation for RELVAR® ELLIPTA®. (Source: GSK news)
Source: GSK news - November 18, 2013 Category: Pharmaceuticals Source Type: news
Five inspirational organisations from Malawi, Bangladesh, Mali, Kenya, and Colombia recognised by GSK and Save the Children
A simple low-cost device that helps newborn babies to breathe and has the potential to transform the life chances for thousands of African babies has been awarded the highest fund in the first GSK and Save the Children $1million Healthcare Innovation Award (Source: GSK news)
Source: GSK news - November 14, 2013 Category: Pharmaceuticals Source Type: news
GSK announces top-line results from pivotal Phase III study of darapladib in chronic coronary heart disease
Study did not meet the primary endpoint measure. (Source: GSK news)
Source: GSK news - November 12, 2013 Category: Pharmaceuticals Source Type: news
GSK names inaugural winners in unique competition for academic drug hunters
GSK today announced the selection of eight winners in its first Discovery Fast Track competition, designed to translate academic research into starting points for new potential medicines. (Source: GSK news)
Source: GSK news - November 6, 2013 Category: Pharmaceuticals Source Type: news
GSK announces new apprentice and graduate engineering opportunities in the UK during Tomorrow’s Engineers Week
GSK today announced the recruitment of 140 new apprentices over the next two years in the UK – of which a third will be in engineering. (Source: GSK news)
Source: GSK news - November 5, 2013 Category: Pharmaceuticals Source Type: news
GSK announces data to support Cervarix® two-dose schedule for the prevention of cervical cancer in 9-14 year old girls
GlaxoSmithKline (GSK) plc today announced the results of a Phase III study of its HPV vaccine, Cervarix. (Source: GSK news)
Source: GSK news - November 4, 2013 Category: Pharmaceuticals Source Type: news
New partnership between GSK and the Bill & Melinda Gates Foundation to accelerate research into vaccines for global health needs
GSK and the Bill & Melinda Gates Foundation (BMGF) today announced the launch of a new joint initiative that will endeavour to make vaccines more resistant to heat, thus reducing the need for refrigeration. (Source: GSK news)
Source: GSK news - October 29, 2013 Category: Pharmaceuticals Source Type: news
Synflorix™ receives positive opinion from the CHMP in Europe for additional pneumonia indication
GlaxoSmithKline plc (GSK) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an additional indication for Synflorix™, ™, a paediatric pneumococcal conjugate vaccine. (Source: GSK news)
Source: GSK news - October 25, 2013 Category: Pharmaceuticals Source Type: news
ViiV Healthcare announces European regulatory submission for a single-tablet regimen combining dolutegravir with abacavir and lamivudine for people living with HIV
ViiV Healthcare today announced the submission of a regulatory application in Europe for its investigational single-tablet regimen (STR) combining dolutegravir (DTG), abacavir (ABC) and lamivudine (3TC) for the treatment of people living with HIV. (Source: GSK news)
Source: GSK news - October 25, 2013 Category: Pharmaceuticals Source Type: news
