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.
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In a 6 to 5 vote, the FDA's Vaccines and Related Biological Products Advisory Committee has determined that Connecticut-based Protein Sciences hasn't proven that its innovative flu vaccine
The FDA's Vaccines and Related Biological Products Advisory Committee today will determine whether Protein Sciences' flu vaccine FluBlok, which can be produced in less than two months by inserting