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Compounding pharmacies registering with the FDA for oversight are being drawn to the federal regulator by the appeal of knowing they meet the highest quality standards and to free themselves from complex and varied state laws. Read More
The Centers for Medicare & Medicaid Services (CMS) plans to force makers of antidepressants and immunosuppressants to compete for inclusion on Medicare Part D formularies, which it hopes will compel drugmakers to lower prices, a possible boon for the generics industry. Read More
Highlighting a growing dispute in the pharmaceutical industry, Johnson & Johnson is arguing that biosimilars should have international non-proprietary names (INN) that are similar to, but distinguishable from, reference products. Read More
Drug distributors are suing Barr Pharmaceuticals and Boehringer Ingelheim (BI), alleging in a class-action complaint that the drugmakers crafted a $120 million pay-for-delay deal to keep a generic version of BI’s stroke drug Aggrenox off the market until at least July 2015. Read More
Generic drugmakers are pushing back against proposed new tight deadlines for responding to FDA questions about ANDAs, and the industry also wants the agency to show greater leniency in dealing with deficiencies in applications. Read More
Generic and brand drugmakers are urging the FDA to drop plans to require them to report manufacturing stoppages expected to result in shortages within five days of the stoppage occurring. Read More
The FDA and EMA will expand their joint inspection activities to include facilities involved with bioequivalence studies for generic drug applications. Read More
The FDA and the World Health Organization (WHO) are considering placing new restrictions on 26 popular painkillers, including the widely used generic opioids tramadol and tapentadol. Read More
With patents expiring on several blockbuster drugs in 2014, generic competition and cost-containment policies around the globe will hold brand pharma’s revenue growth at bay this year. Read More
Dramatic spikes in the prices consumers and pharmacies are paying for generic drugs — as much as a 1,000-percent increase in some cases — have sparked a Senate investigation into generic drug pricing practices. Read More
Dramatic spikes in the prices consumers and pharmacies are paying for generic drugs — as much as a 1,000-percent increase in some cases — have sparked a Senate investigation into generic drug pricing practices. Read More