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Sponsors of brand, generic and biosimilar drugs applying for marketing authorization through the EU’s centralized procedure must begin including facility inspection information in their applications. Read More
The FDA is warning that Pfizer’s Chantix smoking-cessation aid may cause seizures or, when taken with alcohol, lead to unusual or aggressive behavior. Read More
The FDA Friday gave a green light to the first U.S. biosimilar, finding Sandoz’s Zarxio clinically comparable to Amgen’s blockbuster chemotherapy product Neupogen. Read More
The FDA has established a public docket so that compounding pharmacies and others can share their experiences and views regarding the agencies drug compounding regulations. Read More
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
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
Particulate contamination and a labeling error prompted Hospira to recall single lots of two injectable drugs, 0.9 percent sodium chloride injection and magnesium sulfate injection in 5 percent dextrose. Read More