Healthcare Sector Review: Bristol Myers FDA Letter, JNJ Secret Studies
Bristol Myers Squibb Co. (NYSE:BMY): Bristol-Myers Squibb Co. and AstraZeneca (NYSE:AZN) announced that the U.S. FDA has issued a complete response letter regarding the New Drug Application, or NDA, for investigational compound dapagliflozin for the treatment of type 2 diabetes in adults. The complete response letter requests additional clinical data to allow a better assessment of the benefit-risk profile for dapagliflozin. This includes clinical trial data from ongoing studies and may require information from new clinical trials. Bristol-Myers Squibb and AstraZeneca will work closely with the FDA to determine the appropriate next steps for the dapagliflozin application, and are in ongoing discussions with health authorities in Europe and other countries as part of the application procedures. Bristol-Myers Squibb and AstraZeneca remain committed to dapagliflozin and its development.
The shares closed at $32.71, down $1.02, or 3.02%, on the day. Its market capitalization is $55.43 billion.
Johnson & Johnson (NYSE:JNJ) allegedly kept secret three studies showing that some patients using Risperdal developed diabetes while claiming the antipsychotic drug didn’t cause the disease, according to a witness testifying in a Texas courtroom, reports Bloomberg.