Few toes tapped as investors heard a familiar tune from Vital Therapies Inc., which said it found encouraging data with a subset of patients in VTI-208, the bombed phase III trial for alcohol-induced liver decompensation (AILD). Read More
Collegium Pharmaceutical Inc., of Canton, Mass., said phase III data published in Pain showed that Xtampza (oxycodone extended-release capsules) met its primary endpoint, with a statistically significant difference in average pain intensity from randomization baseline to week 12 between the Xtampza ER and placebo groups (p = 0.0001). Read More
strong>Epizyme Inc., of Cambridge, Mass. said the FDA has accepted the company's investigational new drug application for tazemetostat for the treatment of adults and pediatric patients with INI1-negative tumors or synovial sarcoma. Read More
Syndax Pharmaceuticals Inc., of Waltham, Mass., said it completed an $80 million series C financing round led by Fidelity Management & Research Co. and Delos Capital Fund LP with participation from EcoR1 Capital, Orbimed, Jennison Associates (on behalf of certain clients), Tavistock Life Sciences, Arrowpoint Partners, Cormorant Asset Management, Biomed Ventures and undisclosed top-tier mutual funds, as well as existing investors Domain Associates, MPM Capital, RusnanoMedInvest and Forward Ventures. Read More
Medivation Inc. will pay a hefty $410 million up front for global rights to Biomarin Pharmaceutical Inc.'s BMN-673 (talazoparib), a phase III poly ADP ribose polymerase (PARP) inhibitor intended to battle BRCA-mutated breast cancer and other malignancies. Read More
LONDON – Tigenix NV is claiming the crown as first to deliver positive phase III data in an allogeneic stem cell therapy, reporting statistically significant results for Cx601 in the treatment of complex perianal fistulas caused by Crohn's disease. Read More
LONDON – Genmab A/S welcomed the announcement that partner Glaxosmithkline plc (GSK) is selling the rights to Arzerra (ofatumumab) in autoimmune diseases for $1.034 billion, saying the new owner, Novartis AG, has greater commitment to this field. Read More
NEW DELHI – Yet another Indian contract research organization (CRO), Hyderabad-based Sipra Labs Ltd., has found itself in hot water after the U.S. FDA issued a warning letter over flaws detected in analytical procedures. Read More
Flu vaccines are simultaneously a triumph of modern medicine and an annual exercise in controlled chaos. Now, two separate research teams have been able to generate antigens that elicited immune responses to a highly conserved region of the type one influenza A virus. Read More
strong>Celltrion Healthcare Co. Ltd., of Incheon, South Korea, notified the FDA that Janssen Biotech Inc., of Horsham, Pa., part of Johnson & Johnson, has filed a patent infringement complaint against its Remsima, a proposed biosimilar to Janssen's Remicade (infliximab). Read More
