Astellas presented summary results from Phase III trials of the Protein Sciences' flu shot it plans to commercialize in Japan. Separately, Takeda signed a deal to begin selling a freeze-dried live attenuated chickenpox vaccine in Japan.
The Connecticut-based biotech won approval for its flu vaccine last year but it faces competition from GlaxoSmithKline, Sanofi and the other established giants of the market.
After winning FDA approval for its influenza vaccine in January, Protein Sciences was faced with a problem: how to wrest market share from competitors. The task is complicated by the fact that, as yet, there is little evidence to show it is more effective than rivals.
Though the United States has made significant progress in the realm of flu vaccines, the country will likely need to wait 5 to 10 years for a universal shot, top federal health officials said.
A heightened flu season and a spate of newly approved influenza vaccines have experts wondering what else they can do to mitigate or prevent the seasonal illness. Next up: A universal flu vaccine administered every 5 to 10 years to fight multiple virus strains and eradicate the need for annual shots.
Five years after little Protein Sciences first went to the FDA in search of an approval of its innovative flu vaccine, regulators have finally agreed to hit the green light to permit the biotech to start marketing the jab.
A little more than a month after taking over vacated manufacturing space in New York from Pfizer, Protein Sciences won regulatory approval from the FDA for a new type of flu vaccine.
Protein Sciences will lease two buildings at Pfizer's Pearl River, NY, site to create a production line for its recombinant influenza vaccine Flublok.
One way to start up a vaccine manufacturing operation is to simply take over a mothballed plant left idle by one of Big Pharma's merger shakeouts. That is exactly what Protein Sciences is doing in New York.
The lease gives Meriden, CT-based Protein Sciences access to 83,000 square feet of space at Pfizer's 550-acre Pearl River campus, which has been subject to cutbacks within the past couple of years.