Acknowledging that its newly selected partner isn't exactly a household name, Amit Munshi, president and CEO of Epirus Biopharmaceuticals Inc., nevertheless expressed full confidence in Poland's Polpharma Group in a profit-sharing collaboration designed to commercialize biosimilars developed by Epirus across a broad swath of territories. Read More
Following a midstage trial showing its fast skeletal muscle activator, tirasemtiv, delivered respiratory and muscular benefits to patients with amyotrophic lateral sclerosis (ALS) despite missing its primary endpoint, Cytokinetics Inc. is launching a phase III trial of the drug to measure its impact on those factors and others, after conversations with regulators gave it confidence to pursue approval. Read More
SHANGHAI – The Shanghai-based contract research organization/contract manufacturing powerhouse, Wuxi Apptec, is on the move again, this time demonstrating its ability to creatively leverage capital markets to fund expansionary plans. Read More
Nanocell firm Engeneic Ltd. started using cancer immunotherapy in its unique way "before anyone else, because we have bacterially derived particles," Managing Director Jennifer MacDiarmid told BioWorld Today. Read More
NEW DELHI – The Indian pharma industry is struggling with data integrity issues that repeatedly crop up during inspections by global regulators; they are tarnishing the industry's reputation while undermining global confidence in Indian products. Read More
Enteris Biopharma Inc., of Boonton, N.J., said it entered a new agreement for continued clinical testing with development partner Cara Therapeutics Inc., of Shelton, Conn., involving Cara's peripherally selective kappa opioid agonist, CR845, for the treatment of acute and chronic pain. Read More
Relypsa Inc., of Redwood City, Calif., said one-year data from the phase II AMETHYST-DN trial of patiromer for oral suspension (FOS), published in the Journal of the American Medical Association, showed that patients with chronic kidney disease and mild or moderate hyperkalemia who were treated with the potassium binder had statistically significant decreases in blood potassium levels from baseline at four weeks, the primary endpoint (p < 0.001). Read More
