We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
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. Read More
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 Glenmark Pharmaceuticals. 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
More drugmakers have weighed in on the FDA’s draft guidance on biosimilar interchangeability, urging the agency to make clear the designation does not mean a product is superior in terms of safety or efficacy. 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
Maryland’s governor allowed a ban on generic drug price gouging to become law without his signature, in part due to reservations over its constitutionality. Read More