Press releases
GSK and Theravance announce FDA acceptance of FF/VI New Drug Application (NDA) submission in the US for COPD
GSK and Theravance, Inc. today announced that the New Drug Application for the once-daily investigational medicine fluticasone furoate “FF”/vilanterol “VI” for patients with chronic obstructive pulmonary disease, has been accepted by the US Food and Drug Administration indicating that the application is sufficiently complete to permit a substantive review.
Regulatory Update: GSK announces submission for a new indication for Synflorix™ in Europe
GlaxoSmithKline plc (GSK) announced today that it has submitted a regulatory application in the European Union (EU) seeking approval of an additional indication for Synflorix™, a paediatric pneumococcal vaccine, for the active immunisation against pneumonia caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 5 years of age.
GSK to acquire five million shares in Response Genetics for US$1.10 per share in cash
GlaxoSmithKline plc (LSE: GSK) today announces that it has acquired five million newly issued shares of Response Genetics Inc. (RGI) (NASDAQ: RGDX) common stock at a purchase price of US$1.10 per share in cash.
GSK and Theravance announce completion of the Phase III programme for once-daily LAMA/LABA (UMEC/VI) in COPD
GlaxoSmithKline plc (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the completion of the phase III programme of an investigational LAMA/LABA involving approximately 6,000 patients with chronic obstructive pulmonary disease (COPD).
GSK announces start of Phase III programme of sirukumab in rheumatoid arthritis
GlaxoSmithKline plc (GSK) today announced that - as part of their collaboration with Janssen Biologics (Ireland) - the Phase III programme evaluating sirukumab (CNTO 136), a human anti-interleukin (IL)-6 monoclonal antibody in the treatment of patients with moderately to severely active rheumatoid arthritis (RA), has commenced dosing.
GlaxoSmithKline reaches agreement to divest majority of Classic Brands in Australia for £172m
GlaxoSmithKline plc (GSK) today announced that it has reached agreement to divest the majority of its “Classic Brands” (25 non-promoted and genericised products) in Australia to Aspen Global Incorporated (Aspen) for approximately £172 million in cash.
European Commission grants marketing authorisation for pazopanib (Votrient®) in the treatment of certain advanced soft tissue sarcoma subtypes
GlaxoSmithKline plc announced today that the European Commission has granted pazopanib marketing authorisation for the treatment of patients with advanced soft tissue sarcoma (aSTS) who have received prior chemotherapy or have progressed within 12 months after (neo) adjuvant therapy.
Regulatory update – GSK announces submissions in the EU and US for dabrafenib and trametinib
GlaxoSmithKline (GSK) plc today announced regulatory submissions in the European Union and United States (US) related to single-agent use of its BRAF inhibitor dabrafenib and MEK inhibitor trametinib to treat patients with BRAF V600 mutation positive metastatic melanoma.
GSK completes acquisition of Human Genome Sciences
GlaxoSmithKline plc (LSE: GSK) today announced that it has completed its acquisition of Human Genome Sciences (NASDAQ: HGSI) for US$3.6 billion on an equity basis, or approximately US$3 billion net of cash and debt. All outstanding shares of HGS were acquired for US$14.25 per share in cash.
GSK announces acquisition of 79% of Human Genome Sciences shares; commences subsequent offering period
GlaxoSmithKline plc (LSE: GSK) today announced the results of its initial tender offer for all outstanding shares of Human Genome Sciences (NASDAQ: HGSI) for US$14.25 per share in cash, valuing HGS at approximately US$3.6 billion on an equity basis, or approximately US$3 billion net of cash and debt.
