Big Pharma has largely exited the antibiotics arena in the past several years, contributing to the dearth of products in the global pipeline as rising antimicrobial resistance becomes a very real public health threat.
Lexington, MA's Cubist Pharmaceuticals is inching toward its second drug approval of the year, hoping to win European and U.S. clearance for a new anti-infective as analysts wonder whether the company is in line for a Big Pharma takeout.
Cubist Pharmaceuticals is recalling 100 lots of its banner antibiotic Cubicin after problems with a contract manufacturer, its third such issue in 12 months.
Cubist is going through a bad patch with outsourced production. The problems began in August 2013, when CMO quality failings prompted Cubist to recall four lots of its injectable antibiotic Cubicin. Having summoned back another lot in April, Cubist has now issued a much larger recall, with about 100 lots affected.
One week before Cubist celebrated the FDA's approval of Sivextro, an antibiotic that figured prominently in its $707 million buyout of a biotech named Trius, the biotech's former CEO filed papers with the SEC outlining a $30 million raise for a new antifungal venture currently called K2 Therapeutics along with $6 million in funds to buy new assets.
Cubist Pharmaceuticals has again been tripped up by one of its contractors, having to recall a single lot of its injectable antibiotic Cubicin because of particulate. The recall comes 8 months after a similar problem led it to recall four lots of the drug.
Cubist's latest antibiotic won praise from a panel of FDA advisers, setting the stage for a likely approval and head-to-head competition with Pfizer's blockbuster Zyvox.
Cubist Pharmaceuticals' in-development antibiotic aced the second leg of its Phase III program, the company said, paving the way for an FDA application and bumping its shares up another 9%.
Just over a month after crossing the T's on a $535 million acquisition by Cubist Pharmaceuticals, Optimer Pharmaceuticals is shedding 177 jobs in the U.S. and Canada, New Jersey's Star-Ledger reports.
Shares of Cubist Pharmaceuticals surged this morning after the Lexington, MA-based company announced that it had reaped promising data from its Phase III of its antibiotic candidate ceftolozane/tazobactam in complicated urinary tract infections.