ProFibrix BV, of Leiden, the Netherlands, completed enrollment of its pivotal Phase III trial with Fibrocaps, called FINISH-3, on schedule

This is the second big failure of the lipid technology in five months, with Clavis reporting in November that CO-101 (CP-4126), a modified formulation of gemcitabine, had not shown any effect on overall survival in a 360-patient pivotal Phase II study in metastatic pancreatic cancer, conducted in partnership with Clovis Oncology Inc., of Boulder, Colo

This is the second big failure of the lipid technology in five months, with Clavis reporting in November that CO-101 (CP-4126), a modified formulation of gemcitabine, had not shown any effect on overall survival in a 360-patient pivotal Phase II study in metastatic pancreatic cancer, conducted in partnership with Clovis Oncology Inc., of Boulder, Colo

Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., said the independent data monitoring committee recommended that the company continue as planned its pivotal Phase III study testing Firdapse for the treatment of Lambert-Easton myasthenic syndrome (LEMS), a rare autoimmune disorder characterized by muscle weakness of the limbs

for $160 million up front, plus additional, undisclosed milestones based on the clinical, regulatory and commercial progress of its main asset, lifitegrast, which is undergoing a second pivotal Phase III trial in dry eye disease

for $160 million up front, plus additional, undisclosed milestones based on the clinical, regulatory and commercial progress of its main asset, lifitegrast, which is undergoing a second pivotal Phase III trial in dry eye disease

NeuroVive Pharmaceutical AB, of Lund, Sweden, said the 600th patient was recruited in its pivotal Phase III European, multicenter CIRCUS (does Cyclosporine ImpRove Clinical oUtcome in ST elevation myocardial infarction patients) trial assessing CicloMulsion in heart reperfusion injury following stenting in patients with myocardial infarction

for $160 million up front, plus additional, undisclosed milestones based on the clinical, regulatory and commercial progress of its main asset, lifitegrast, which is undergoing a second pivotal Phase III trial in dry eye disease

The company is recruiting patients in its pivotal Phase III EPIC study and is pursuing strategic alliances

The resubmission will use data from two pivotal Phase III studies and focus on the safety aspects of Iluvien and the population of DME patients considered insufficiently responsive to available therapies

NeuroVive Pharmaceutical AB, of Lund, Sweden, said the 600th patient was recruited in its pivotal Phase III European, multicenter CIRCUS (does Cyclosporine ImpRove Clinical oUtcome in ST elevation myocardial infarction patients) trial assessing CicloMulsion in heart reperfusion injury following stenting in patients with myocardial infarction

Acadia Pharmaceuticals Inc., of San Diego, presented results from its pivotal Phase III -020 study with pimavanserin in patients with Parkinson's disease psychosis, with the analysis of the full dataset from the study showing robust and consistent efficacy of pimavanserin across a wide array of study measures and confirming the positive top-line results previously reported

Newron Pharmaceuticals SpA and its partner, Zambon SpA, remain on track to file for approval for safinamide as add-on therapy in Parkinson's disease in the fourth quarter, following the release of pivotal Phase III data at the annual meeting of the American Academy of Neurology in San Diego this week

Newron Pharmaceuticals SpA and its partner, Zambon SpA, remain on track to file for approval for safinamide as add-on therapy in Parkinson's disease in the fourth quarter, following the release of pivotal Phase III data at the annual meeting of the American Academy of Neurology in San Diego this week

enrolled its first subject in a second pivotal Phase III trial, called OPUS-2, with 5 percent lifitegrast ophthalmic solution

Radius Health Inc., of Cambridge, Mass., said it completed enrollment for its pivotal Phase III study of BA058-subcutaneous, a bone-building synthetic peptide analogue, reaching the enrollment target of 2,400 subjects

With those rights, Cubist now owns worldwide rights to develop, manufacture and commercialize ceftolozane/tazobactam, which, as CXA 201 , is being study in two pivotal Phase III trials as a potential first-line intravenous therapy for the treatment of complicated intra-abdominal infections and complicated urinary tract infections caused by certain Gram-negative bacteria

Ltd. (Tokyo) ARQ197 Tivantinib Hepatocellular carcinoma Enrolled their first patient in a pivotal Phase III trial 2/1/13 AVEO Pharmaceuticals Inc. (Cambridge, Mass.) Tivozanib A once-daily, VEGF receptor tyrosine kinase inhibitor Advanced renal cell carcinoma Showed overall survival trends favoring the comparator drug Nexavar (sorafenib) at 29.3 months, compared with 28.8 months for tivozanib 2/14/13 Cel-Sci Corp. (Vienna, Va.) and Orient Europharma Co...a high capacity non-absorbed oral potassium

Alchemia Ltd., of Brisbane, Australia, said it completed enrollment in a pivotal Phase III trial evaluating HA-Irinotecan for the treatment of metastatic colorectal cancer, with 415 patients recruited, including 71 subjects enrolled in a substudy designed to provide additional pharmacokinetic and cardiotoxicity data