Health Canada gave the nod to Sanofi Pasteur Canada to expand the indication for Menactra to infants 9 months of age.
Novartis ($NVS) hit a key turning point with its vaccines division when a European Union committee backed the company's Bexsero meningitis shot.
Novartis has scored a key endorsement for one of the brightest stars from its vaccines division. The European Union's Committee for Medicinal Products for Human Use (CHMP) backed approval of Bexsero, the Swiss drug giant's ($NVS) meningitis B vaccine that could become the first such shot to hit the market if the European Commission follows the CHMP's advice.
Novartis' struggling vaccine unit got a shot in the arm today when the European Medicines Agency (EMA) recommended for approval, Bexsero, its potential blockbuster vaccine for meningitis B.
The World Health Organization deemed an inexpensive meningitis vaccine safe out of cold storage for four days, meaning health workers can more easily transport the drug to remote parts of Africa where meningitis A is common.
As FDA Commissioner Margaret Hamburg prepared to testify before Congress about the deadly meningitis outbreak, reports surfaced that the agency wanted to shut New England Compounding Center down to fix manufacturing violations in 2003, but deferred to state regulators who apparently dropped the ball.
A Centers for Disease Control and Prevention panel recommended the use of GlaxoSmithKline's MenHibrix vaccine for bacterial meningitis for use in babies at increased risk of infection.
As a Minnesota woman became the first patient to sue New England Compounding over the meningitis outbreak suspected to have originated there, the company hired a prominent criminal-defense firm, and federal and state authorities stepped up their probes.
As the meningitis outbreak spreads, so does the fallout from it. A second company in Massachusetts is suspending operations, The Boston Globe reports, while officials investigate. Meanwhile, calls for tougher oversight of pharmaceutical compounding are, predictably, intensifying.
The vaccine targets infections with Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type B, and is given as four doses between 6 weeks and 18 months of age. Both of these infections can cause meningitis.