ARIAD Announces U.S. Resumption of Marketing and Commercial Distribution of Iclusig (ponatinib) in Refractory Philadelphia-Positive Leukemias

ARIAD Pharmaceuticals, Inc. (ARIA) today announced that the U.S. Food and Drug Administration (FDA) has approved revised U.S. Prescribing Information (USPI) and a Risk Evaluation and Mitigation Strategy (REMS) for Iclusig^® (ponatinib) that allows immediate resumption of its marketing and commercial distribution. The USPI includes a revised indication statement and boxed warning, updated safety information and recommendations regarding dosing considerations for prescribers.

Oramed Announces Successful Results from Ex-US Pharmacokinetic Study of its Oral Insulin for the Treatment of Type 1 Diabetes

Company Additionally Anticipates Results from Phase 2a FDA Study for Type 2 Diabetes in January

Oramed Pharmaceuticals Inc. (ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today successful results in a clinical trial testing the pharmacokinetic dose response of its oral insulin capsule (ORMD-0801) in type 1 diabetes patients. 

Patients were treated with a different dose of oral insulin at each study visit; blood glucose and insulin levels were then monitored for the ensuing five hours.  Patient responses positively correlated with administered doses, as did the duration of the effect.

Alimera Sciences and FDA Enter Into Labeling Discussions for ILUVIEN®, Agree Advisory Committee No Longer Necessary

Alimera Plans to Respond to October Complete Response Letter in First Quarter 2014

Alimera Sciences, Inc. (ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it has entered into labeling discussions with the U.S. Food and Drug Administration (FDA) for ILUVIEN® and, as a result, reached an agreement with the FDA that Alimera's participation in the January 2014 Dermatologic and Ophthalmic Advisory Committee meeting was no longer necessary. Alimera will focus instead on drafting its response to the Complete Response Letter (CRL) received from the FDA in October 2013 with a goal of submitting the response in the first quarter of 2014.

Depomed Acquires CAMBIA® (Diclofenac Potassium for Oral Solution) Migraine Medicine from Nautilus Neurosciences for $48.7 Million

Depomed, Inc. (DEPO) today announced that it has acquired the United States rights to CAMBIA® (diclofenac potassium for oral solution) from Nautilus Neurosciences for $48.7 million. In addition, Depomed may pay Nautilus up to an additional $5 million based on the achievement of certain annual net sales milestones. CAMBIA is a non-steroidal anti-inflammatory drug (NSAID) indicated for acute treatment of migraine attacks with or without aura in adults 18 years of age or older.