News

European Commission approves Hexyon/Hexcima (Sanofi Pasteur) Six in One vaccine

Sanofi Pasteur, the vaccines division of Sanofi has announced that the European Commission, on 22 April 2013, approved Sanofi Pasteur’s 6-in-1 pediatric vaccine Hexyon/Hexacima (DTaP-IPV-Hib-HepB vaccine) for primary and booster vaccination of infants from six weeks of age. Hexyon/Hexacima is the only fully liquid, ready-to-use, 6-in-1 vaccine to protect infants against diphtheria, tetanus, pertussis (whooping cough), Hepatitis B, poliomyelitis ...

UK and German approvals for FLUARIX TETRA (GSK) influenza vaccine

GSK announced the marketing authorisation of its quadrivalent (four-strain) influenza vaccine in Germany and the UK. Following a decentralised procedure, Germany’s Paul Ehrlich Institut (PEI) was the first national regulatory authority in Europe to grant marketing authorisation for this influenza vaccine, followed by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. This is the first four-strain ...

Complete Response Letter from FDA for Q-Pan H5N1 influenza vaccine

GSK has received a Complete Response Letter from the FDA for its pandemic influenza A vaccine, called Q-Pan H5N1. Q-PAN H5N1 is intended for the prevention of Infuenza in adults who are at increased risk of exposure to the H5N1 influenza virus subtype contained in the vaccine.

In November 2012, the FDA’s Vaccines and Related Biological Products Advisory Committee ...

RTS,S Malaria Vaccine (GSK) disappoints

The effectiveness of a Malaria Vaccine, RTS,S, developed by GlaxoSmithKline wanes over time, with the shot protecting only 16.8 percent of children over four years, according to trial data. The disappointing results for RTS,S - the world's first potential malaria vaccine - raise further questions about whether it can make a difference in the fight against the disease, a major ...

Positive topline results from Phase III trial of Enterovirus 71 vaccine (Sinovac Biotech) against Hand, Foot and Mouth Disease

Preliminary top-line data from a Phase III clinical trial assessing the efficacy, immunogenicity and safety of Enterovirus 71 vaccine, from Sinovac Biotech, against Hand, Foot and Mouth Disease, showed that the vaccine was 95.4% efficacious against HFMD. The Phase III trial involving 10,000 healthy infants of 6 to 35 months old showed good immunogenicity and safety.

The overall incidence of ...

CHMP recommends Hexyon/Hexacima vaccine (Sanofi Pasteur)

The CHMP has recommended market approval for the 6-in-1 pediatric vaccine Hexyon/Hexacima (DTaP-IPV-Hib-HepB vaccine), from Sanofi Pasteur. The new vaccine will be commercialized under the brand name Hexyon in Western European countries by Sanofi Pasteur MSD, the joint venture between MSD and Sanofi Pasteur, and under the brand name Hexacima in Eastern European countries by Sanofi Pasteur. The new vaccine ...

FDA approves extension of Prevnar 13 vaccine indication

Pfizer Inc. has announced that the FDA has granted approval on 25 January 2013 for the expansion of the company’s pneumococcal conjugate vaccine, Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), for use in older children and adolescents aged 6 years through 17 years for active immunization for the prevention of invasive disease caused by the 13 Streptococcus ...

RTS.S anti malaria vaccine further results in African study

Results from a pivotal, large-scale Phase III trial, published online in the New England Journal of Medicine, show that the RTS,S malaria vaccine candidate can help protect African infants against malaria. When compared to immunization with a control vaccine, infants (aged 6-12 weeks at first vaccination) vaccinated with RTS,S had one-third fewer episodes of both clinical and severe malaria and ...

Sanofi Pasteur has submitted Hexaxim vaccine to EMA for approval in Europe

The Hexaxim vaccine (DTaP-IPV-Hib-HepB) has been submitted by Sanofi Pasteur MSD to the EMA for approval to licence within the European Union. Upon approval the company says it will commercialise it in its European territories under its own brand name. The new hexavalent vaccine, developed by Sanofi Pasteur, is the only fully liquid, ready to use 6-in-1 vaccine to protect ...

Sanofi Pasteur Dengue vaccine success in clinical trial

Sanofi Pasteur, the vaccines division of Sanofi announced that its tetravalent Dengue Vaccine candidate demonstrated proof of efficacy against Dengue, a threat to almost 3 billion people, in the world’s first ever dengue efficacy trial conducted in Thailand, with excellent safety. The vaccine generated antibody response for all four dengue virus serotypes. Evidence of protection was demonstrated against three of ...

Repligen files Secreflo with EMA for detection of Pancreatic Duct Abnormalities

Repligen has submitted a marketing authorization application (MAA) for SecreFlo (synthetic human secretin) as an agent to improve the detection of pancreatic duct abnormalities in patients with Pancreatitis. SecreFlo stimulates secretion of watery fluid into the pancreatic ducts. When the ducts are filled with water they are more effectively visualised. FDA decision expected on 21 June 2012....