GSK and Genmab announce positive interim result for phase III study of ofatumumab as maintenance therapy for relapsed CLL
GlaxoSmithKline plc (LSE/NYSE: GSK) and Genmab A/S (OMX: GEN) announced today that an Independent Data Monitoring Committee (IDMC) interim analysis of a phase III study, PROLONG (OMB 112517), reached the predefined significance level for efficacy (p≤0.001). The interim analysis demonstrated that treatment with ofatumumab (Arzerra™) met the primary endpoint of improving progression free survival (PFS). The study evaluated ofatumumab maintenance therapy versus no further treatment (observation) in patients with relapsed chronic lymphocytic leukaemia (CLL) who responded to treatment at relapse. (Source: GSK news)
Source: GSK news - July 31, 2014 Category: Pharmaceuticals Source Type: news
FDA approves Flonase allergy relief for sale over-the-counter in the United States
No. 1 prescribed allergy treatment ingredient1 to be available OTC (Source: GSK news)
Source: GSK news - July 24, 2014 Category: Pharmaceuticals Source Type: news
GSK announces EU regulatory submission for malaria vaccine candidate RTS,S
GSK announced today that it has submitted a regulatory application to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S. (Source: GSK news)
Source: GSK news - July 24, 2014 Category: Pharmaceuticals Source Type: news
Results announcement for the second quarter 2014
GSK delivers Q2 2014 turnover £5.6 billion (-4%) and core EPS 19.1p (-12%) on ex-divestment basis (both CER). Q2 dividend 19p (+6%). (Source: GSK news)
Source: GSK news - July 23, 2014 Category: Pharmaceuticals Source Type: news
ViiV Healthcare presents phase III data comparing once-daily maraviroc in combination with darunavir/ritonavir with emtricitabine/tenofovir plus darunavir/ritonavir in treatment-naïve adults with HIV-1
An investigational two drug-regimen of maraviroc dosed once daily, combined with darunavir/ritonavir (DRV/r) showed inferior efficacy compared to emtricitabine/tenofovir (FTC/TDF) with DRV/r. (Source: GSK news)
Source: GSK news - July 22, 2014 Category: Pharmaceuticals Source Type: news
Trametinib (Mekinist™) and dabrafenib (Tafinlar™) combination demonstrated overall survival benefit compared to vemurafenib; phase III BRAF V600-mutant metastatic melanoma study stopped early
GlaxoSmithKline plc (LSE/NYSE: GSK) announced today that the Independent Data Monitoring Committee (IDMC) recommended COMBI-v (MEK116513), a phase III study of its MEK inhibitor, trametinib (Mekinist™), in combination with its BRAF inhibitor, dabrafenib (Tafinlar™), compared to vemurafenib in patients with BRAF V600E or V600K mutation-positive unresectable or metastatic cutaneous melanoma be stopped early. (Source: GSK news)
Source: GSK news - July 17, 2014 Category: Pharmaceuticals Source Type: news
GSK and Theravance announce initiation of phase III programme with fixed dose triple combination treatment FF/UMEC/VI in patients with COPD
GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the start of a global phase III study, known as IMPACT, to evaluate the efficacy and safety of the ‘closed’ triple combination of FF/UMEC/VI in patients with chronic obstructive pulmonary disease (COPD). (Source: GSK news)
Source: GSK news - July 16, 2014 Category: Pharmaceuticals Source Type: news
GSK receives EU marketing authorisation for Mekinist™ (trametinib) for patients with unresectable or metastatic melanoma with a BRAF V600 mutation
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the European Commission (EC) has granted marketing authorisation for Mekinist™ (trametinib) as a single agent in the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. (Source: GSK news)
Source: GSK news - July 4, 2014 Category: Pharmaceuticals Source Type: news
Anoro® Ellipta® (umeclidinium/vilanterol) gains approval in Japan for the treatment of COPD
GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Anoro® Ellipta® (umeclidinium/vilanterol). (Source: GSK news)
Source: GSK news - July 4, 2014 Category: Pharmaceuticals Source Type: news
GSK and Genmab receive EU authorisation for Arzerra™ (ofatumumab) as first-line treatment for chronic lymphocytic leukaemia (CLL) in combination with chlorambucil or bendamustine for patients ineligible for fludarabine-based therapy
GlaxoSmithKline plc (LSE: GSK) and Genmab A/S (OMX: GEN) announced today that the European Commission (EC) has granted marketing authorisation for a new indication for the use of Arzerra™. (Source: GSK news)
Source: GSK news - July 3, 2014 Category: Pharmaceuticals Source Type: news
GSK statement on UK Government-initiated review of antibiotic resistance
“We welcome today’s announcement of a review to explore the economic issues surrounding antimicrobial resistance. This is a positive step towards addressing this global public health threat... (Source: GSK news)
Source: GSK news - July 2, 2014 Category: Pharmaceuticals Source Type: news
GSK and Theravance announce submission to US regulatory authorities for fluticasone furoate/vilanterol in asthma
GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA). (Source: GSK news)
Source: GSK news - June 30, 2014 Category: Pharmaceuticals Source Type: news
GSK and Save the Children offer $1 million award for healthcare innovations in developing countries that reduce child deaths
GSK and Save the Children today announced the launch of their second annual $1 million Healthcare Innovation Award at the Partnership for Maternal, Newborn and Child Health meeting in South Africa. (Source: GSK news)
Source: GSK news - June 30, 2014 Category: Pharmaceuticals Source Type: news
GSK and Genmab announce top-line results from a Phase III study of ofatumumab versus physicians’ choice for bulky fludarabine-refractory CLL
GlaxoSmithKline plc (LSE: GSK) and Genmab A/S (OMX: GEN) announced today that the Phase III study of ofatumumab (Arzerra™) versus physicians’ choice in patients with bulky fludarabine-refractory chronic lymphocytic leukaemia (CLL) did not meet its primary endpoint of progression free survival (PFS). The median PFS, as assessed by the Independent Review Committee, was 5.36 months for ofatumumab and 3.61 months for physicians’ choice (Hazard Ratio 0.79, p=0.267). (Source: GSK news)
Source: GSK news - June 27, 2014 Category: Pharmaceuticals Source Type: news
Triumeq® (dolutegravir/abacavir/lamivudine) single-tablet regimen receives positive CHMP opinion in Europe for the treatment of HIV
ViiV Healthcare’s first investigational once-daily single-tablet regimen, combining the integrase inhibitor dolutegravir and nucleoside analogues abacavir/lamivudine (Source: GSK news)
Source: GSK news - June 27, 2014 Category: Pharmaceuticals Source Type: news
