The China Food and Drug Administration is taking public comments on four proposed reforms, covering the review of new drug applications, the deregulation of clinical trials, postmarket surveillance and intellectual…
Scott Gottlieb was sworn in as the 23rd FDA commissioner May 11, with plans to face the nationwide opioid crisis, which he has called the agency’s number one challenge, and…
Spending on medicines topped $450 billion in 2016, rising less than half as fast as the industry has seen over the past two years. Source: Generic Line
Astellas Pharma filed suit against generics makers Roxane Laboratories, West-Ward Pharmaceuticals and Hikma Pharmaceuticals over their copycat version of Xtandi. Source: Generic Line
Fifty-two representatives and nine senators sent letters to HHS Secretary Tom Price and CMS Administrator Seema Verma, urging them to reverse current Medicare policy for the reimbursement for biosimilar products.…
The FDA approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit hyperactivity disorder in pediatric and adult patients, including multiple strengths manufactured by Apotex, Teva, Aurobindo Pharma and…
Merck and Upsher-Smith Laboratories agreed to pay $60.2 million to settle a 17-year-long class action suit over plans to delay a generic potassium deficiency treatment — a case that survived…
Celltrion has filed two petitions against a Genentech patent with the PTO, requesting an inter partes review of a method for making antibodies related to Herceptin. Source: Generic Line
The FDA published 21 new and 16 revised product-specific draft guidances, outlining methods for establishing bioequivalence for generics. Source: Generic Line
Amgen is suing Coherus Biosciences over its processes for manufacturing a biosimilar of Neulasta, saying it infringes patented methods for purifying proteins. Source: Generic Line