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CDER Director Janet Woodcock is calling on industry to collaborate in the development and verification of new biomarkers, which the agency says can improve clinical trial efficiency but so far have been underused. Read More
Keryx Biopharmaceuticals said it will launch its renal disease drug ferric citrate within 12 weeks, following FDA approval Friday of the product that controls phosphorus levels in dialyzed chronic kidney disease (CKD) patients. Read More
A federal judge has tossed out all claims in a consolidated class-action antitrust lawsuit alleging that brandmaker Warner Chilcott executed a “reverse payment” to generics firms Watson (now Actavis) and Lupin Pharmaceuticals to delay generic competition on its contraceptive Loestrin 24. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is leading a three-year initiative that seeks to harness the power of social media to report adverse drug events. Read More
Drugmaker OncoMed expects to resume enrollment and dosing of new patients for its experimental cancer drug ipafricept in the coming weeks, after the FDA lifted a partial hold on its clinical trials. Read More
A slew of leaky, deteriorating products, an insect infestation and poor complaint handling resulted in another Form 483 for beleaguered injectables giant Hospira. Read More
More than a year after being warned by the FDA for poor quality, Alexion Pharmaceuticals received a fresh Form 483 for problems surrounding gowning procedures and other quality issues. Read More
Beleaguered Indian generics maker Wockhardt has initiated a voluntary Class II recall of 11,661 bottles of metoprolol succinate, a generic version of AstraZeneca’s blood pressure drug Toprol-XL. Read More