GSK news

GSK provides update on regulatory filings for Zunrisa/Rezonic

GlaxoSmithKline (GSK) has made the difficult decision to discontinue the regulatory filings for Zunrisa/Rezonic (casopitant), which was being developed for chemotherapy-induced and post-operative nausea and vomiting.

Pandemic (H1N1) 2009 Influenza Update: GSK’s H1N1 ‘Pandemrix’ vaccine receives positive opinion from European Regulators

GlaxoSmithKline (GSK) announced today that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion and recommends approval of GSK’s candidate pandemic (H1N1) adjuvanted vaccine Pandemrix™.

Pandemic (H1N1) 2009 Influenza Update: Initial results from first clinical trial of GSK’s H1N1 adjuvanted vaccine

GlaxoSmithKline (GSK) today announced results from its first clinical trial assessing use of its pandemic (H1N1) adjuvanted vaccine.

FDA Advisory Committee makes favorable recommendation for Cervarix, GlaxoSmithKline’s candidate cervical cancer vaccine

GlaxoSmithKline announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that clinical data support both the efficacy and safety of CERVARIX®, the company’s candidate cervical cancer vaccine (12-1 and 11-1, respectively).

GlaxoSmithKline and Genmab announce top-line results for ofatumumab in rheumatoid arthritis

GSK and Genmab A/S announced today preliminary top-line results from a Phase III study of ofatumumab administered intravenously for the treatment of rheumatoid arthritis (RA) in patients who had an inadequate response to methotrexate.

Regulatory update: mepolizumab for the treatment of hypereosinophilic syndrome (HES)

GSK today announced that it has notified the European Medicines Agency of its decision to withdraw the Marketing Authorisation Application (MAA) in the EU for mepolizumab for the treatment of hypereosinophilic syndrome (HES).

Amgen to collaborate with GSK to commercialize denosumab in Europe for postmenopausal osteoporosis (PMO)

Amgen to retain full rights for denosumab in the United States and Canada and for oncology indications in Europe. GlaxoSmithKline will commercialize denosumab for PMO and oncology in Emerging Markets.

GlaxoSmithKline update: Government orders for pandemic (H1N1) 2009 vaccine

GSK is committed to supporting governments and health authorities around the world respond to the pandemic (H1N1) 2009 influenza strain.

GSK and Brazil’s Fiocruz form partnership for new R&D effort and increased vaccine access

GlaxoSmithKline plc (GSK) announced today that it has launched a unique partnership with Brazil’s Oswaldo Cruz Foundation (Fiocruz) to develop and manufacture vaccines for pressing public health priorities in Brazil.

Pandemic (H1N1) 2009 influenza update

GSK today issued an update on its progress to develop a vaccine against the Pandemic (H1N1) 2009 influenza virus, and announced that it has commenced the clinical development programme for its adjuvanted pandemic vaccine. Enrolment into this first study has been completed.

Syndicate content