The U.S. Food and Drug Administration approved Novartis AG’s biosimilar version of Amgen Inc.’s arthritis drug Enbrel.
AbbVie’s biologic therapy Humira for autoimmune diseases was the worldwide prescription-drug sales leader in 2015 for the fourth consecutive calendar term.
Valeant Pharmaceuticals International Inc.’s experimental drug to treat the skin disorder psoriasis should be approved as long as certain measures are put in place to mitigate the risk of suicide.
Indianapolis-based Eli Lilly and Company is on a roll, announcing that between 2014 and 2023, it may launch 20 new products.
Hyberabad, India-based Dr. Reddy’s Laboratories announced today that it had inked a licensing deal with Santa Clara, Calif.-based XenoPort worth more than $490 million.
The pharma industry’s R&D concentration has been shifting towards specialty therapy areas as research and development returns decline for some leaders.
January 28, 2016 By Mark Terry, BioSpace.com Breaking News Staff Cambridge, Mass.-based Biogen Inc. (BIIB) announced its 2015 financial and fourth-quarter reporting yesterday, citing $10.8 billion in annual revenues, an increase of 11 percent over 2014. Biogen exceeded analysts expectations, who were predicting a revenue increase of about 9 percent. Net income was $3.6 […]
U.S. health regulators declined to approve Pfizer Inc’s oral rheumatoid arthritis drug Xeljanz to treat moderate to severe cases of the scaly skin condition plaque psoriasis, the drugmaker said on Wednesday. Pfizer said it received a so-called complete response letter from the Food and Drug Administration. Such letters typically outline concerns and conditions that must […]
The U.S. Food and Drug Administration has accepted Novartis (NOVN.VX) unit Sandoz’s regulatory submission for approval of a biosimilar copy of Amgen’s (AMGN.O) blockbuster Enbrel drug, the Swiss drugmaker said on Friday. Biosimilars aim to copy biologic products, which are made inside living cells, but they can never be exact duplicates, so biosimilar manufacturers […]
Xenoport Inc said it would stop developing on its own a drug that showed high rates of side effects in a study and instead focus on its treatment for restless leg syndrome. The company also said on Thursday that Ronald Barrett, its chief executive since 2001, has stepped down and will be succeeded by Chief […]