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Complaints of particulates found in vials of nine lots of Cubist Pharmaceuticals’ anti-infective drug Cubicin prompted the company to initiate its second recall of the drug in as many days. Read More
Drugmakers could see their wait time to begin clinical trials in Brazil cut by more than a third under a proposed regulation calling for protocols to be reviewed in their entirety, rather than stage by stage, which is the current policy. Read More
To improve ANDA submissions, the FDA should spend more time with generics companies before they file an application, as is done with brand manufacturers in the run-up to an NDA, the Generic Pharmaceutical Association says. Read More
The FDA has given Mapp Biopharmaceutical its blessing to send two additional doses of its experimental ZMapp Ebola monoclonal antibody to Liberia, after agency officials facilitated communication between the drugmaker and Liberian health officials. Read More
A patient advocacy group is using a recently created pathway for challenging generic drugs through the U.S. Patent and Trademark Office to contest the patent on Wyeth’s antibiotic Tygacil outside a Hatch-Waxman ANDA. Read More
Drugmakers are worried that FDA draft guidance on how to identify and report counterfeit or suspicious goods could lead to numerous false alarms and potential shortages unless the guidance is amended. Read More
Countries in the Caribbean are working to establish a unified registration process for generic drugs, an effort aimed to improve the quality, availability and access to essential therapies. Read More
Subsidiaries of generics maker Hetero Drugs can move forward with generic versions of kidney drug PhosLo despite an ongoing lawsuit brought by patent owner Roxane Laboratories. Read More
New Jersey-based Mutual Pharmaceutical and two other generic firms are suing brand manufacturer Reckitt Benckisser for breach of contract, alleging that RB reneged on a license agreement to provide generic supplies of its cold and flu medicine Mucinex for sale. Read More
Indian generics firm Dr. Reddy’s has filed the first patent challenge against Teva’s blockbuster multiple sclerosis drug Copaxone’s 40 mg, introducing a new chapter into the Israeli drugmaker’s efforts to protect its multibillion dollar product. Read More