Kadmon Corp. LLC, of New York, said data from a phase Ib trial evaluating tesevatinib (formerly KD019), the company's oral tyrosine kinase inhibitor, in combination with Herceptin (trastuzumab, Roche AG) for the treatment of patients with HER2-positive metastatic breast cancer with brain metastases, showed that the combination appears to be well tolerated, and one heavily pretreated patient with brain metastases had prolonged stable disease with gradual discontinuation of steroids. Read More
Amp Biosimilars AG, of Hamburg, Germany, said it out-licensed a biosimilar, ABY-018, a humanized monoclonal antibody, to a leading, midsized Chinese pharma company with a portfolio of more than 50 pharma products. Read More
Rxi Pharmaceuticals Corp., of Marlborough, Mass., said it priced a public offering of 26 million units at a price of 40 cents per unit for gross proceeds of about $10.4 million. Read More
SHANGHAI – Sciclone Pharmaceuticals Inc., a Foster City, Calif.-based company that brings specialty therapeutics to the China market, has secured a deal for China (including Hong Kong, Macau, Taiwan and Vietnam) with Theravance Biopharma Inc., for Vibativ (telavancin), a lipoglycopeptide antibiotic that addresses difficult-to-treat hospital-acquired infections and ventilator-assisted infections. Read More
Researchers have used gene therapy to prevent type 1 diabetes in mice, providing proof of principle that gene therapy can be used to treat autoimmunity. Moreover, in combination with low doses, an antibody targeting the costimulatory molecule CD3, the gene therapy was able to reverse the symptoms of type 1 diabetes in the animals. Read More
HONG KONG – Biotech and medtech companies operating in China now have to pay more attention to the cost of regulatory approvals after the national regulator drastically raised registration application fees for both clinical trials and marketing approvals. Read More
While it is still early days, the microbiome space is heating up with a number of biotech start-ups appearing on the scene over the past 12 months. Cambridge, Mass.-based Seres Therapeutics Inc. is hoping to capitalize on that rising tide of investor interest by filing its S-1 registration statement with the SEC to raise up to $100 million in an IPO. Read More
The FDA's approval of Viberzi (eluxadoline) and the label extension for Xifaxan (rifaximin), both to treat irritable bowel syndrome with diarrhea (IBS-D) in adults, offered additional validation for the M&A approach of specialty pharmas Actavis plc and Valeant Pharmaceuticals International Inc. Read More
