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Canadian generics maker Apotex’s plant in Bangalore, India, has rampant problems with data manipulation, including continuously retesting batches until the desired result is achieved, the FDA charged in a warning letter. Read More
Sponsors of clinical trials in the European Economic Area must begin posting summary results on the EudraCT clinical trials database starting July 21, another move in Europe’s shift toward greater clinical trial transparency. Read More
Actavis’ proposed generic version of Novartis’ dementia-treatment Exelon Patch infringes on the product’s patent, a federal judge ruled Thursday in a case that centered on whether a specific chemical ingredient was “obvious” to include in the drug. Read More
Tianjin Zhongan Pharmaceutical’s manufacturing facility in China failed to follow cleaning procedures and maintain records on equipment operations, according to an FDA warning letter that cites various current good manufacturing practice (cGMP) violations. Read More
SAN DIEGO — The FDA is racing to beat a fall deadline to release a string of new guidances for generics makers that it hopes will head off a potential torrent of rejected submissions. Read More
The FDA is making minor changes to its recommendations for companies developing new investigational drugs to treat all types of uncomplicated gonorrhea, expanding eligibility for clinical trial participation to include subjects who are HIV-positive and adopting rapid diagnostic tests to select patients for enrollment. Read More
GPhA is stepping up its opposition to the FDA’s proposed generics labelling rule, releasing a survey that shows more than half of physicians, physician assistants and pharmacists would find the new system confusing for them and their patients. Read More
The UK’s health care costs regulator is overhauling its recommendations for management of stroke risk in patients with atrial fibrillation, recommending physicians turn to three new generation anticoagulants rather than commonly-used warfarin or aspirin. Read More
Injectables maker Hospira is facing yet another recall after a customer found particulates embedded in a vial of 0.5 percent Marcaine painkiller. Read More
Novartis is hoping a federal judge will dismiss a Department of Justice kickback lawsuit against it based on the drugmaker’s argument that the government hasn’t shown a cause-and-effect relationship between the alleged kickbacks to pharmacies and increased sales of its products. Read More