March 27 (Reuters) - U.S. Food and Drug Administration:
* FDA says approved Biogen idec's tecfidera (dimethyl fumarate)
capsules to treat adults with relapsing forms of Multiple Sclerosis
* Source text for Eikon:
* Further company coverage ((Bangalore Newsroom; +1 646 223 8780))
March 21 (Reuters) - Titan Pharmaceuticals Inc :
* FDA advisers vote 10-5 to agree clinical study data on Titan'S Probuphine
give substantial proof of its effectiveness to treat opioid dependance
* FDA advisers vote 12 yes, 2 no, 1 abstain on whether Titan adequately
characterized safety profile of Probuphine in the intended patient population
* FDA advisers vote 5 yes, 4 no, 6 abstain on whether rems proposed by Titan
are adequte to address risks of potential complications of Probuphine use
* FDA advisers vote 10 yes, 4 no, 1 abstain on whether efficacy, safety and
risk-benefit profile of Titan'S Probuphine support drug's approval
* Further company coverage ((Bangalore Newsroom; +1 646 223 8780))
March 18 (Reuters) - Abbott Laboratories :
* FDA staff says approval of Abbott's MitraClip not appropriate at the
time as major questions of safety, efficacy & risks remain unanswered
* FDA staff recommends Abbott's MitraClip to remain available for high risk
patients so Abbott can conduct its trials in an optimal manner
* FDA staff says the analyses included in Abbott's MitraClip marketing
application do not have valid scientific evidence of safety & efficacy
* Source text * Further company coverage ((Bangalore Newsroom; +1 646 223 8780))
March 14 (Reuters) - ProMetic Life Sciences Inc :
* US FDA grants orphan-drug designation to ProMetic's plasma-derived
plasminogen drug
* Says orphan drug designation is for the treatment of hypoplasminogenemia, or
type I plasminogen deficiency
* Source text * Further company coverage ((Bangalore Newsroom; +1 646 223 8780))
