Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today said they are on track to submit their NDA for linaclotide for both irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC) indications in 3Q of 2011. They also intend to submit a Market Authorization Application (MAA) for linaclotide with the European Medicines Agency for the IBS-C indication in 2H 2011.
Depomed, Inc. (Nasdaq:DEPO) announced today that it has completed enrollment of their Breeze 3 pivotal Phase 3 clinical trial evaluating Serada (extended release gabapentin tablets) for the non-hormonal treatment of menopausal hot flashes. They maintained previous guidance of data release 4Q this year.
Palatin Technologies, Inc. (NYSE: PTN) announced Thursday that the FDA has cleared their request to begin Phase 2a subcutaneously administered formulation of PL-3994 for the treatment of acute exacerbations of asthma.
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced top-line results from DURATION-6, a head-to-head study designed to compare weekly BYDUREON to daily Victoza for Type 2 diabetes. The study did not meet its primary endpoint, with patients receiving BYDUREON experienced a reduction in A1C of 1.3 percentage points from baseline, compared to a reduction of 1.5 percentage points for Victoza. They still plan to resubmit their NDA for BYDUREON in 2H of 2011, following their CRL late last year.
InterMune, Inc. (Nasdaq: ITMN) today announced that the European Commission (EC) has granted marketing authorization for Esbriet (pirfenidone). Esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease.
Infinity Pharmaceuticals, Inc. (Nasdaq:INFI) today announced the initiation of a randomized, double-blind Phase 2 clinical trial to evaluate the safety and efficacy of IPI-926 compared to placebo in patients with metastatic or locally advanced, inoperable chondrosarcoma.
Celldex Therapeutics, Inc. (NASDAQ: CLDX) today said that they expect to complete enrollment of the 120-patient randomized Phase 2b controlled study of CDX-011 for the treatment of patients with glycoprotein NMB (GPNMB)-expressing advanced, refractory breast cancer including triple negative disease. They also intend to initiate an international, double-blinded, placebo-controlled, randomized Phase 3 pivotal study of rindopepimut in approximately 300 patients with GBM that express EGFRvIII during the 2H of 2011.
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced publication of results from a Phase 2 trial of their Pancreas Cancer Vaccine increased the median survival of resected pancreatic cancer patients from 15 to 20 months, as reported in published data, to 24.8 months. BUT it should be noted that it was only a single arm trial only.