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Astellas Pharma will launch its antifungal drug Cresemba in the coming months, following FDA approval for adults with invasive aspergillosis and invasive mucormycosis — rare, but serious fungal infections most often seen in patients with compromised immune systems. Read More
CorePharma will divest generic rights to a dry mouth therapy and a liver drug to clear the way for Impax’s $700 million acquisition of the Middlesex, N.J., drugmaker. Read More
Sun Pharmaceuticals is recalling 5,322 bottles of Ketorolac tromethamine ophthalmic solution in the U.S. and Puerto Rico for failing to meet specifications. Read More
Contract OTC manufacturer Gopers Int. doesn’t have a quality control unit, keep batch records or properly train its employees, according to an FDA Form 483 that features a litany of quality violations. Read More
Luitpold Pharmaceuticals was chided by the FDA for failing to properly investigate how severe roof leaks in 2013 and 2014 affected production. Read More
Three European industry groups are asking the European Commission to block an Italian law that encourages off-label drug use, saying it is driven entirely by economics at the expense of patient health. Read More
Bristol-Myers Squibb and Pfizer’s Eliquis won a positive nod in the UK, with the National Institute for Health and Care Excellence deeming it clinically effective and cost-effective in treating and preventing blood clots in the lungs, pelvis, legs or arms. Read More
Gilead Sciences has ratcheted up efforts to get the Supreme Court to hear a double patenting lawsuit, arguing the Federal Circuit’s ruling invalidating patent protection for its influenza drug Tamiflu effectively rewrites the obviousness-type double patenting doctrine. Read More