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Home » Topics » Regulatory

Regulatory
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FDA approves botulism antitoxin manufactured by Cangene

March 27, 2013

Chugai gains Japanese approval for subcutaneous formulation of Actemra

March 27, 2013

Shionogi receives approval for metreleptin in Japan

March 27, 2013

Acofide tablets approved in Japan for functional dyspepsia

March 27, 2013

FDA approves Navidea's imaging drug Lymphoseek

March 14, 2013

U.K. approval for Duexis for osteoarthritis, rheumatoid arthritis and ankylosing spondylitis

March 8, 2013

Lundbeck's Selincro approved in E.U. for alcohol dependence

March 1, 2013

European Commission approves Ilaris in acute gouty arthritis indication

March 1, 2013

Omontys Recall Rings Alarm Over Biosimilars

Feb. 27, 2013
By Mari Serebrov
Despite what the New York Times and its echoers have said, makers of innovative biologics have legitimate reason to sound alarms about automatic substitution of biosimilars that have not proven their interchangeability – and it’s not just because of the potential impact to their bottom line. That point was driven home by the recent recall of Affymax Inc. and Takeda Pharmaceutical Co. Ltd.’s Omontys (peginesatide). Although Omontys is not a biosimilar, the unexpected postmarketing reports of serious hypersensitivity reactions linked to the erythropoiesis-stimulating agent (ESA) served as a reminder of the variability of biologics, their sensitivity to minute manufacturing changes...
Read More

FDA approves Osphena for the treatment of dyspareunia

Feb. 27, 2013
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