In a two-step scheme, specialty vaccine developer Paxvax Inc. acquired the FDA-approved oral typhoid vaccine Vivotif from Crucell Switzerland AG and financed the deal with $50 million in secured debt from an investment fund managed by Pharmakon Advisors and $12 million in an extension of its series B preferred stock. The Redwood City, Calif.-based company, whose lead product is a single-dose cholera vaccine in a phase III program, now takes up the challenge of transforming from a small biotech to a commercial venture.
Acelrx Pharmaceuticals Inc. didn't have to wait for its Sunday PDUFA date for Zalviso, but the company also didn't receive the FDA approval it sought and analysts largely expected. Instead, the FDA late Friday issued a complete response letter (CRL) for the pain management product, seeking more information about the device to ensure proper use.
Three months ago, Puma Biotechnology Inc. ran into Wall Street headwinds on findings from its adaptive I-SPY 2 (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2) trial of PB272 (neratinib), a pan-HER tyrosine kinase inhibitor, as neoadjuvant therapy in metastatic breast cancer.
Synlogic Inc. tucked a $29.4 million series A into its belt as it aims at the nexus of synthetic biology and the microbiome with the development of therapeutic microbes. Atlas Venture and New Enterprise Associates led the round, which will enable Cambridge, Mass.-based Synlogic to build out its microbial engineering platform and advance its preclinical pipeline through clinical proof of concept in several applications.
Petisation. You might be tempted to call it revenge of the lab rats. But the technology developed by Australian animal health company Nexvet Biopharma to adapt monoclonal antibodies (MAbs) developed for humans for use in animals – maintaining efficacy at the proper dose without risk of rejection – takes the lucrative animal health business to the next level.
The small biotech Sotio AS, of Prague, has shunned the limelight since its founding in 2010. Instead of promoting its potential to treat various forms of cancer, the company is letting its technology do the talking.
Petisation. You might be tempted to call it revenge of the lab rats. But the technology developed by Australian animal health company Nexvet Biopharma to adapt monoclonal antibodies (MAbs) developed for humans for use in animals – maintaining efficacy at the proper dose without risk of rejection – takes the lucrative animal health business to the next level.
Myos Corp., which is taking a bifurcated approach in developing products to improve muscle mass, increase mobility and reduce frailty, is going to the "cloud" through a research and development agreement with newco Cloud Pharmaceuticals Inc. Although terms were not disclosed, the partners will focus on identifying and advancing candidates that inhibit targets in the myostatin regulatory pathway and inflammatory mediators associated with sarcopenia and cachexia.
Researcher John Lambris has devoted his career of more than 30 years to exploring the human complement system. His lab at the University of Pennsylvania, where Lambris serves as professor of research medicine in the department of pathology and laboratory medicine, was among the first in the world to map the critical sites on the human C3 protein that are responsible for its many functions and to define its complex binding dynamics to various C3 natural ligands.
Suzhou Alphamab Co. Ltd. is among the new generation of Chinese biopharmas moving rapidly along the evolutionary curve from contract research activities such as high-throughput screening, analytical biology and process development to the construction of a pipeline of biosimilars and, most recently, the development of novel compounds directed at cancer, autoimmune and infectious diseases.