DUBLIN – Merck & Co. Inc. is in line to obtain conditional marketing authorization from the European Union for its live attenuated vaccine for preventing Ebola virus infection, V920 Ebola Zaire vaccine (rVSVDG-ZEBOV-GP live), following a positive recommendation for approval from the EMA's Committee for Human Medicinal Products (CHMP) at its October meeting last week. Formal approval should follow within 67 days, after which the Kenilworth, N.J.-based pharma would market the vaccine as Ervebo. Read More
CEO Christine Bunt of Verseau Therapeutics Inc. told BioWorld that the company has prepared a "wave" of prospects from its macrophage checkpoint modulator (MCM) platform ready to crash upon the shores of cancer therapy, with 23 novel targets in the hopper. Read More
BEIJING – Cancer and autoimmune specialist Innocare Pharma Ltd., of Beijing, is seeking a pre-revenue listing on the Hong Kong Stock Exchange (HKEX) to raise capital to advance its BTK inhibitor, ICP-022, to an NDA filing in China by the end of this year. Read More
His parents likely expected Henri Termeer to find his position in the shoe business that the family had run for several hundred years but, after his advanced schooling, Termeer had other ideas. Biotech observers today may wonder who can fill the moccasins of the trailblazer that Termeer became. Read More
It took newly launched Plexium Inc. CEO Kandaswamy (Swamy) Vijayan a few years to figure out where he needed to focus his creative energies. With an engineering background, he helped develop diagnostic tools. But he wanted to take the skill further. Read More
WASHINGTON – The U.S. FDA's 2018 final guidance for payer communications widely was seen as long overdue upon delivery. For his part, Paul Savidge, U.S. general counsel at Philadelphia-based Spark Therapeutics Inc., said his company's development of the required information for such communication was "a massive undertaking" that proved useful a second time when it came to promoting its product after FDA approval. Read More
Researchers at the Abramson Cancer Center at the University of Pennsylvania have developed an algorithm to better personalize immunotherapy treatment. The algorithm works by examining neoantigen quality, not just their quantity. Neoantigens are proteins that are the result of genetic mutations in a tumor. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More
