Gene therapy at last is coming into its own with a new kind of "p" value, said Bluebird Bio Inc. CEO Nick Leschly. "Instead of publications, it's now about patients," he said, commenting on positive results from a phase I/II trial with a gene therapy against beta-thalassemia major – data that started followers of Bluebird speculating on whether the approach will work in sickle cell disease (SCD), too. Read More
LONDON – Convergence Pharmaceuticals Ltd. is laying plans to raise £40 million to £50 million (US$68 million to $84 million) for a phase IIb/III trial of its sodium channel blocker CNV1014802, after reporting positive results in a phase II study of patients suffering severe facial pain trigeminal neuralgia (TGN). Read More
Shares in Cardio3 Biosciences SA gained almost 6 percent Monday on news that the company raised €25 million (US$33.9 million) from an Asian investor, Medisun International Ltd., which is also committing another €20 million to a joint venture that will take on clinical development and commercialization of its flagship stem cell therapy for ischemic heart failure in the People's Republic of China (PRC), Taiwan and Hong Kong. Read More
LONDON – Antibody discovery services specialist Abzena Ltd. is planning an initial public offering (IPO) on the Alternative Investment Market in London to raise cash to grow its business and access paper to smooth the way for merger and acquisition activity. Read More
Shares in Actelion Ltd. rose 15 percent during trading Monday on news that selexipag, its first-in-class selective oral prostacyclin IP receptor agonist, met the primary endpoint of a phase III outcomes trial in 1,156 patients with pulmonary arterial hypertension (PAH). Read More
Biogen Idec Inc. looked to expand its multiple sclerosis (MS) franchise with positive top-line findings from the phase III DECIDE trial of daclizumab, in joint development with partner Abbvie Inc. Read More
SHANGHAI – Last week the CFDA put out a circular to warn Chinese consumers about the dangers of buying cancer medicines online, in particular drugs that claim to be Iressa (gefitinib) imported from India. Read More
Oxford Biomedica plc, of London, raised £21.6 million (US$36.6 million) through a financing, after disclosing plans to generate £25.7 million. Read More
Kadmon Corp. LLC, of New York, said it established a Cooperative Research and Development Agreement with the National Institute of Dental and Craniofacial Research (NIDCR) to develop an adeno-associated virus vector containing human aquaporin-1 gene (AAV2hAQP1) for the treatment of xerostemia resulting from the use of ionizing radiation (IR) in the treatment of head and neck cancer. Read More
Biolinerx Ltd., of Jerusalem, said it received approval from Israeli regulators to start a phase I trial of BL-8040, a treatment for the mobilization of stem cells from the bone marrow to the peripheral blood circulation. Read More
Intarcia Therapeutics Inc., of Boston, reported six-month data from an ongoing open-label phase III trial with ITCA 650 in type 2 diabetes, showing marked improvements in glycemic control among patients with severe hyperglycemia and longstanding type 2 diabetes. Read More
Novartis AG, of Basel, Switzerland, said the FDA licensed its manufacturing facility in Holly Springs, N.C., to produce cell culture influenza vaccines. Read More
