Barr Pharmaceuticals undertakes first biologic drug initiative
MONTVALE, N.J. The Food and Drug Administration will review a generic drug maker’s application for a biologic drug.
Barr Pharmaceuticals announced Thursday that the FDA would review subsidiary Duramed Pharmaceuticals’ biologics license application for a Adenovirus Types 4 and 7 Live Oral Vaccines. Barr said this represents its first in-house biologics initiative.
“We are very pleased to have our first BLA accepted for filing by the FDA and believe that we have achieved a significant step in building our biologics program,” Barr chairman and chief executive officer Bruce Downey said in a statement. “Working together with Department of Defense over the past six years, we have made significant progress in meeting critical unmet medical needs for our armed forces.”
The vaccines are designed to fight against wild type 4 and type 7 adenovirus-using antibodies. Both viruses cause respiratory infections, and type 4 can cause acute respiratory disease, which often affects military recruits. Barr and the DoD conducted a Phase 3 study that involved more than 4,000 male and female recruits at Navy and Army training facilities. The DoD and Barr entered an agreement to develop the vaccines in 2001.
Rite Aid upgrades cash registers to support FSA cards
CAMP HILL, Pa. Rite Aid has upgraded its pharmacy and front-end cash registers to make it easier for shoppers to use their Flexible Spending Account debit cards.
The pharmacy retailer is utilizing an inventory information approval system to allow customers to pay for eligible healthcare items with FSA debit cards. Eligible healthcare purchases on receipts are identified with an H to the right of the item’s price. These items are tallied by the cash register and can be paid for by an FSA debit card. The remaining balance for non-eligible items is paid for separately.
The FSA debits cards work similar to other debit cards and allow customers to buy certain health items using funds from a pre-tax accounts.
FDA delays approval of Remoxy painkiller
NEW YORK The Food and Drug Administration announced that it needed more clinical studies of the pain pill Remoxy before it would approve it.
The pill, a formulation of oxycodone by King Pharmaceuticals and Pain Therapeutics, is designed in a capsule form that prevents abuse by people trying to get high.
On Wednesday, King Pharmaceuticals’ shares were down by 83 cents, at $9.13, and Pain Therapeutics were down by $1.82, at $5.93.