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The FDA is planning a public workshop in July to evaluate the impact of abuse-deterrent formulations of opioid painkillers, and to find ways to better inform the agency’s regulatory approach, following recently renewed calls to action. Read More
The Senate Health, Education, Labor and Pensions Committee sought to answer basic questions on what is driving drug prices sky high, in a Tuesday hearing ostensibly dedicated to the pharmaceutical industry — though it was frequently derailed by Democrats’ concerns over Republican efforts to repeal and replace the Affordable Care Act. Read More
The European Commission has opened a formal antitrust investigation into South African manufacturer Aspen Pharma over concerns of excessive pricing of five cancer medicines. Read More
Biosimilars consistently drive down average drug prices in markets where they are introduced, according to a report ordered by the European Commission. Read More
Health Canada is proposing changes to its prescription drug pricing regulations with the establishment of a risk-based approach, applying new economic factors in the decision framework, and updating the list of countries it uses for average price comparisons. Read More
The PTO’s Patent Trial and Appeal Board invalidated a patent for AbbVie’s flagship drug Humira, saying its claims were unpatentable following a challenge by Coherus Biosciences. Read More
Astellas Pharma filed suit against generics makers Roxane Laboratories, West-Ward Pharmaceuticals and Hikma Pharmaceuticals over their copycat version of Xtandi. Read More
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 three rounds of mediation, over four years of discovery, and a trip to the Supreme Court. Read More
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. Read More
Amgen is suing Coherus Biosciences over its processes for manufacturing a biosimilar of Neulasta, saying it infringes patented methods for purifying proteins. Read More