FDA briefing documents released Friday morning in advance of Tuesday's Arthritis Advisory Committee Meeting suggested the agency will go gentle on the biologics license application for CT-P13, Celltrion Inc.'s biosimilar to Remicade (infliximab, Janssen Biotech Inc.) that is approved elsewhere as Remsima (infliximab). . Read More

Looking ahead to the pivotal trial in triple-negative breast cancer (TNBC) with IMMU-132, slated to begin this summer, Immunomedics Inc. stands as "the only game in town at the moment this far along that has an antibody that targets this [TROP-2] receptor," Chau Cheng, director of investor relations, told BioWorld Today. Read More

HONG KONG – Despite a bearish market, biopharma companies in China are looking to tap new funds or investors. And a nascent bidding war for one of the country's best known vaccine makers is a case in point. Read More

HONG KONG – Neurobiologists at the Hong Kong University of Science and Technology (HKUST) have discovered a novel strategy to promote axon regeneration after central nervous system (CNS) injury, which could lead to the development of potentially clinically useful non-invasive methods to stimulate neuronal activity and eventually the possible repair of spinal injury. Read More

Although definitions of personalized medicine vary greatly from one person and organization to the next, the term gets thrown around a lot in the context of oncology – for good reason. There simply is no one-size-fits-all approach to fighting cancer. Read More

In previous cycles of interest in the Israeli medical environment, investing in a venture capital vehicle might have been considered the only means to encounter Israeli technologies for financial and perhaps strategic players. That approach has been broadened with many new financial, strategic collaboration approaches available for the world's biomedical-field players to interact and commit to Israel. Venture capitalists from all over the world have come to recognize the value of Israel innovations in the health care sector, and are flocking to invest there. Read More

Agile Therapeutics Inc., of Princeton, N.J., reported that the underwriters of its previously announced public offering of common stock have exercised in full their option to purchase an additional 826,771 shares, sold at the public offering price of $6.35 per share. The closing occurred on Feb. 4, bringing the total number of shares sold by Agile in the public offering to about 6.3 million, yielding gross proceeds of about $40.25 million. Net proceeds are expected to be about $37.3 million. William Blair and RBC Capital Markets acted as joint book-running managers, while Janney Montgomery Scott, Cantor Fitzgerald & Co. and FBR Capital Markets acted as co-managers. Read More

Vertex Pharmaceuticals Inc., of Boston, said it received a complete response letter from the FDA for its supplemental new drug application (sNDA) for the use of Kalydeco (ivacaftor) in people with cystic fibrosis (CF), ages 2 and older, who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Read More

Aralez Pharmaceuticals Inc., of Vancouver, British Columbia, disclosed completion of the business combination of Pozen Inc., of Chapel Hill, N.C., and Tribute Pharmaceuticals Canada Inc., of Milton, Ontario. Read More

A team from Massachusetts General Hospital has developed a CRISPR-based technique to engineer microdeletions and microduplications. Such microdeletions and microduplications of relatively small stretches of the genome lead to copy number variations (CNVs). Read More