GSK Get The Go-ahead for Acquisition of Novartis’ Vaccines Business

Regulatory update on transaction with Novartis November 26, 2014 GlaxoSmithKline plc is today providing this update to its announcement of 22 April 2014 relating to the major three-part transaction with Novartis AG (the Original Announcement). The US Federal Trade Commission (FTC) has voted to approve GSK’s proposed acquisition of Novartis’s vaccines business (excluding influenza vaccines) and the proposed creation of …

GSK Statement on First Phase 1 Trial Results of a Candidate Ebola Vaccine

November 24, 2014 First results from a small phase 1 trial published today in the New England Journal of Medicine show that a GSK/NIH Ebola candidate vaccine was well-tolerated and produced an immunological response in each of the 20 healthy adult volunteers in the USA who received it. The candidate vaccine used in the trial conducted by the National Institutes …

Merck enters the Ebola Vaccine Race in NewLink Partnership

Merck obtains the rights to NewLink genetics’ experimental Ebola Vaccine, putting pressure on GSK Merck has struck a agreement with NewLink Genetics to licence their investigational Ebola vaccine, rVSV-EBOV. The $50 million agreement gives Merck exclusive rights to develop, manufacture, and distribute the vaccine across the world. This partnership should allow NewLink to keep pace with the huge effort by …

Nine-valent HPV Vaccine May Prevent Nearly 90 Percent of Cervical Cancers

October 1, 2014 Because nine human papillomavirus (HPV) subtypes were found to cause the majority of cervical precancers, a nine-valent HPV vaccine currently being investigated may be able to prevent more cervical cancers than current vaccines, according to research published in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research. “We wanted to study how …

Ebola vaccine trials fast-tracked by international consortium

Unprecedented international consortium assembled to accelerate collaborative multi-site trials of candidate Ebola vaccine August 28, 2014 A candidate Ebola vaccine could be given to healthy volunteers in the UK, The Gambia and Mali as early as September, as part of a series of safety trials of potential vaccines aimed at preventing the disease that has killed more than 1,400 people …

World’s first Malaria Vaccine Submitted for Approval to EMA

GlaxoSmithKline submits the first malaria vaccine for approval by the European Medicines Agency and the World Health Organization The vaccine, named RTS,S, targets Plasmodium falciparum parasite. This parasite is most commonly found in sub-Saharan, where 90% of malaria related deaths occur. Children under 5 account for 77% of the deaths. The vaccine uses the AS01 adjuvant system, and works by preventing …

GSK announces EU regulatory submission for malaria vaccine candidate RTS,S

July 24, 2014 GSK announced today that it has submitted a regulatory application to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S. The submission will follow the Article 58 procedure, which allows the EMA to assess the quality, safety and efficacy of a candidate vaccine, or medicine, manufactured in a European Union (EU) member state, for a …

Vaccine Asia Live: Accelerating Vaccine Development in Asia through Public-Private Partnership(PPP)

Live at World Vaccine Congress Asia 2014, the day was opened with a panel discussion on accelerating vaccine deelopment in Asia through Public-Private Partnerships(PPP). Andrew Potter, CEO of PREVENT Canada moderated the discussion with Lanling Zou of NIAID USA, Duane Gubler of SUKW-NUS Graduate Medical School Singapore  and Stephen Cook of GSK Belgium. It was a great start to a …

Vaccines & Formula 1: The future of BigData

There has been numerous articles in the industry regarding Big Data analytics in pharmaceutical R&D – particularly searching for new therapeutic candidates in drug discovery and ‘real world’ post approval vigilance. What has not being reviewed in depth is the use of Big Data in manufacturing solutions. However Pharma, like many sports science, engineering and retail sectors, are now harnessing …