Keyword: Aurobindo Pharma
Indian drugmakers pick up U.S. generics scripts; Chi-Med files for Hong Kong listing; an explosion at a Qilu Pharma subsidiary kills 10.
Traditional generics bigwigs Teva, Mylan, Sandoz, Amneal and Endo have lost out to a group of six competitors in terms of U.S. weekly prescriptions.
Nobel laureate wants bigger PD-1 revenue cut; Takeda scouts buyers for Latin America business; Chinese genomics investor is forced out of U.S. firm.
Even as Aurobindo grows its footprint in the U.S., the FDA continues to find problems in its manufacturing.
The FDA declared 40 generic hypertension drugs free from the three potentially carcinogenic compounds that cropped up in the "sartan" class.
The detection of a third suspected cancer-causing contaminant in valsartan drugs has forced the FDA to again scramble to figure out risks.
Daiichi rejigs management; China approves its first biosimilar; Sinovac uses a poison pill to fend off an investor takeover.
The FDA has made another trip to the key Aurobindo sterile manufacturing facility in India and has again found it lacking.
Immunomedics says it will meet with the FDA to discuss the CRL it got for manufacturing, while Teva has a new union agreement in place.
Terns names ex-Gilead executive as CMO; Spectrum sells all FDA-approved drugs to Aurobindo; Aslan's varlitinib fails in gastric cancer.