Clik here to view.
Malaria vaccine candidate RTS,S has demonstrated efficacy over 3-4 years of...
Final results from a large-scale Phase III trial of the RTS,S malaria vaccine candidate, including the impact of a booster dose, show that the vaccine candidate helped protect children and infants from...
View ArticleClik here to view.
GSK, Telethon and OSR announce EU regulatory submission for gene therapy to...
GSK, Fondazione Telethon and Ospedale San Raffaele (OSR) have submitted a marketing application to the European Medicines Agency (EMA) for a gene therapy (GSK2696273) to treat patients with a rare...
View ArticleClik here to view.
Pfizer to acquire GSK meningitis vaccines
Pfizer has entered into an agreement with GlaxoSmithKline (GSK) to acquire its quadrivalent meningitis ACWY vaccines, Nimenrix and Mencevax, for $130 million. Nimenrix is a single dose meningococcal...
View ArticleClik here to view.
GSK begins shipping 2015-16 US flu vaccines
GSK has begun shipping Flaurix® Quadrivalent (influenza vaccine) doses to US healthcare providers, following licensing and lot-release approval from the US Food and Drug Administration’s (FDA) Centre...
View ArticleClik here to view.
CHMP adopts positive scientific opinion of malaria vaccine Mosquirix
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive scientific opinion for GSK’s malaria candidate vaccine Mosquirix in children aged...
View ArticleClik here to view.
CHMP grants label extension for GSK’s Synflorix
GSK has announced that the label for its pneumococcal vaccine Synflorix has been expanded. The Committee for Medicinal Products for Human Use (CHMP) granted approval to include protection against...
View ArticleClik here to view.
Novartis pays $1 billion to bolster its pipeline with ofatumumab
Novartis is to acquire all remaining rights to ofatumumab from GSK for up to $1 billion plus royalties. Ofatumumab, a fully human monoclonal antibody which targets CD20, is being developed for...
View ArticleClik here to view.
Merial Sas, GSK, Sanofi Pasteur, Nestle Research Center will meet at the...
Microbiological contamination of products and processes continues to be a major concern to the pharmaceutical industry and its regulations. Contamination of an aseptic process can have a serious impact...
View ArticleClik here to view.
Results from the SUMMIT COPD CV survival study announced
GlaxoSmithKline (GSK) and Theravance have announced initial results from the SUMMIT COPD study for Relvar/Breo Ellipta (fluticasone furoate/vilanterol or FF/VI) 100/25mcg. The study involved 16,485...
View ArticleClik here to view.
CHMP recommends mepolizumab for severe refractory eosinophilic asthma
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for GSK’s Nucala (mepolizumab) as an...
View ArticleClik here to view.
GSK’s losmapimod cardiovascular study fails
GSK has announced that an interim review of data from part A of its losmapimod phase III study, LATITUDE-TIMI 60, did not indicate efficacy against the primary endpoint and did not support investment...
View ArticleClik here to view.
GSK’s candidate shingles vaccine demonstrates 90% efficacy against shingles
GSK’s candidate shingles vaccine demonstrates 90% efficacy against shingles, in adults aged 70 years and over. GlaxoSmithKline plc announced today that the second pivotal phase III study of its...
View ArticleClik here to view.
GSK and Merck initiate Phase I trial of GSK3174998 with Keytruda
GSK and Merck have announced the initiation of a Phase I clinical trial designed to evaluate GSK’s GSK3174998 as monotherapy and in combination with Merck’s Keytruda (pembrolizumab) in patients with...
View ArticleClik here to view.
GSK announces Phase III results for belimumab in SLE
GSK has announced results from the BLISS-SC Phase III pivotal study of Benlysta (belimumab) administered subcutaneously in patients with active, autoantibody-positive systemic lupus erythematosus...
View ArticleClik here to view.
Phase III study of sirukumab in giant cell arteritis starts
Dosing has commenced in a Phase III study evaluating GSK’s sirukumab, a human anti-interleukin (IL)-6 monoclonal antibody, for the treatment of patients with giant cell arteritis (GCA). GCA is a type...
View ArticleClik here to view.
Amgen reacquires product rights to 3 products from GSK
Amgen has entered into a definitive agreement with GSK to reacquire all of its remaining rights to Prolia (denosumab), XGEVA (denosumab) and Vectibix (panitumumab) in 48 countries. The agreement...
View ArticleClik here to view.
Comic Relief and GSK team up to help fight malaria
Comic Relief and GSK are teaming up in support of global efforts to strengthen health systems’ capabilities to fight malaria. A new fund – created through a £17m donation from GSK and £5m from Comic...
View ArticleClik here to view.
GSK initiates Phase 1 study of IONIS-HBV-LRx; Ionis gets milestone payment
Ionis Pharmaceuticals has announced that GSK has initiated a Phase 1 study of IONIS-HBV-LRx. IONIS-HBV-LRx (previously referred to as ISIS-GSK6-LRx) is a drug Ionis is developing with GSK for the...
View ArticleClik here to view.
Presentation videos from the World’s 1st International Pharmaceutical seminar...
Videos of the presentations from the world’s 1st TRS seminar for quantitative pharmaceutical analysis can be viewed on demand at www.cobaltlight.com/trs100seminar. More than 70 delegates from across...
View ArticleClik here to view.
GSK submits sBLA seeking expanded indication for Flulaval Quadrivalent
GSK has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for Flulaval Quadrivalent (Influenza Vaccine). This vaccine is currently approved for...
View Article