Usually the day a biotech discloses an abrupt end to a big pharma partnership – especially if it comes only a few months after reporting troubling side effect data from a phase IIb study – its shares inevitably dip well into the red. Not so for Ardelyx Inc. Read More
HONG KONG – New RNA-based switching biotechnology that detects and sorts cells derived from induced human pluripotent (iPS) cells using microRNAs (miRNAs) will enable production of purer cell populations with potentially better therapeutic outcomes, a study by Japanese researchers at the Center for iPS Cell Research and Application (CiRA) at Kyoto University has found. Read More
LONDON – Kiadis Pharma BV is planning to go public on the Euronext markets in Amsterdam and Brussels to raise funding for phase III development of its cell therapy ATIR, which enables bone marrow transplants from non-identical donors. Read More
Since biosimilars are not generics, they should not be labeled like generic drugs, Abbvie Inc. said in a citizen petition asking the FDA to approve labeling clearly stating that a drug is a biosimilar. Read More
BOGOTA, Colombia – The Brazilian health surveillance agency Anvisa has issued a license for Remsima (infliximab), which gives the green light for Celltrion Inc. to distribute its biosimilar in the Latin American country under the bioequivalence provisions. Read More
Synthetic Biologics Inc., of Rockville, Md., presented initial data at the General Meeting of the American Society of Microbiology in New Orleans, supporting the development of a platform of therapeutics designed to protect the microbiome from carbapenems, a class of beta-lactam antibiotics. Work identified a beta-lactamase, P2A, which has the ability to protect the gut microbiome from a third class of beta-lactam antibiotics, carbapenems. Read More
Vaxinnate Corp., of Cranbury, N.J., has initiated double-blind, randomized, active comparator-controlled phase II study to evaluate the safety and immunogenicity of its VAX2012Q quadrivalent seasonal influenza vaccine candidate. The active comparator is Sanofi Pasteur Inc.'s Fluzone Quadrivalent. Read More
Neostem Inc., of New York, filed a prospectus supplement to its shelf registration with the SEC enabling it to sell up to $30 million in shares of common stock to Aspire Capital Fund LLC subject to certain conditions over a two-year period. As of the March 31, Neostem had about $41 million in cash to fund operations. Read More
