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Two industry groups in India are suing the country’s drug regulatory authority for enacting price controls on scores of branded-generic drugs to treat diabetes and cardiovascular disorders. Read More
Drugs launched after Congress passed legislation to accelerate the approval process are more likely to be given safety warnings or pulled from the market altogether, according to a new study critical of the FDA’s current review process. Read More
The National Institutes of Health is talking with drugmakers about the potential of scaling up production of an experimental recombinant Ebola vaccine set to enter human testing next month. Read More
The European Medicines Agency is seeking suggestions on promising techniques to identify genomic biomarkers that might spur development of targeted therapies. Read More
Impax received its second Form 483 in less than a week for a poor inspection of its U.S. manufacturing facility, igniting fresh doubts on the company’s plan to win approval of its Parkinson’s drug Rytary. Read More
Conducting clinical trials with multiple drug candidates from different manufacturers simultaneously will be key to developing new antibacterial therapies, experts seeking to address the growing problem of antibiotic resistance say. Read More
The FDA approved Boehringer Ingelheim and Eli Lilly’s diabetes drug Jardiance, reversing its rejection this spring based on quality concerns at one of BI’s plants where the drug is made. Read More
The U.S. biotechnology industry has endorsed a recent World Health Organization proposal to give biosimilar products a unique name qualifier that distinguishes them from the reference products’ nonproprietary name, a proposal that may run counter to naming protocols in the generic drug industry. Read More
The FDA delivered its fifth warning letter to a compounding pharmacy in roughly two weeks, admonishing a Texas compounder for poor aseptic processing of sterile drugs. Read More
A Chinese active pharmaceutical ingredient (API) maker was slammed by the FDA for falsifying batch record signoffs and product labeling, the latest international drugmaker to be caught in the agency’s crackdown on poor data integrity. Read More