07/13/2016 - 11:53am
Reuters is reporting that the FDA’s Arthritis Advisory Board has unanimously recommended Amgen’s biosimilar of AbbVie’s Humira, ABP 501. The panel said that the drug was similar in safety and effectiveness to Humira for rheumatoid arthritis and plaque psoriasis, and it recommended that the biosimilar should also be approved for Crohn’s disease in adults and ulcerative colitis. (Reuters)
07/13/2016 - 11:39am

Stansel has previously served as acting general counsel for the Dept. of Health and Human Services, working as the chief legal officer for it and several sub-agencies including the Food and Drug Administration. 

07/12/2016 - 2:48pm

Based on Medicare adherence numbers among diabetic patients, the IMS Institute estimates that complications from type 2 diabetes will cost about $100 billion annually in the United States, with $4 billion attributable to Medicare patients. 

07/12/2016 - 2:43pm

The move is aimed at Nichi-Iko becoming one of the top 10 global generics leaders, and the companies said acquiring Sagent will boost Nichi-Iko’s ability to commercialize its biosimilar pipeline and increase its presence in injectables.

07/12/2016 - 1:59pm

The agency has acted on 90% of the generic drug and prior approval supplement applications pending as of Oct. 1, 2012 — which puts it more than a year ahead of its final deadline of Sept. 30, 2017. 

07/12/2016 - 12:49pm

A new survey by Iowa-based Meyocks has found that Americans place a lot of trust in pharmacists — and a little bit less in doctors and dentists.

07/12/2016 - 12:27pm

Xiidra marks Shire's first approval for a drug in the ophthalmic space, which it hopes to enter using Xiidra as leverage for its pipeline of developing ophthalmic. 

07/12/2016 - 12:01pm

The first Health:Further – Retail Tomorrow partnership initiative will feature executives from Johnson & Johnson and Wakefern Food Corp.

07/12/2016 - 11:39am

FDA approval of the 2016/17 formulation of Flublok means that Flublok is on track to ship to healthcare providers in early August.