Genocea Biosciences Inc., of Cambridge, Mass., completed enrollment in its phase II dose optimization clinical trial for T-cell enabled GEN-003, a first-in-class investigational protein subunit vaccine for the treatment of genital herpes. Read More
Interleukin Genetics Inc., of Waltham, Mass., has agreed to provide genetic testing services for Carlsbad, Calif.-based Isis Pharmaceuticals Inc.'s phase II study of ISIS-APO(a)Rx, in patients with high lipoprotein(a), or Lp(a), an independent risk factor for cardiovascular disease. Read More
Sunovion Pharmaceuticals Inc., of Marlborough, Mass., an indirect, wholly owned subsidiary of Sumitomo Dainippon Pharma Co. Ltd., said the FDA accepted for review a supplemental new drug application for the use of Aptiom (eslicarbazepine acetate) as monotherapy treatment of partial-onset seizures. Read More
Brainstorm Cell Therapeutics Inc., of New York and Petach Tikvah, Israel, said that since Jan. 2 it has received approximately $3.1 million from the exercise of warrants for approximately 700,000 shares, which were issued in a June 2012 private placement. Read More
Genkyotex SA raised CHF20 million (US$20 million) in a series D round to take forward its pipeline of selective NADPH oxidase (NOX) inhibitors in a broad range of indications. Read More
Vtesse Inc., a new rare disease company focused on pushing a potentially transformational lysosomal storage disease (LSD) drug into pivotal testing this year, has raised a $25 million series A round from the syndicate of life sciences investors behind Cydan Development Inc., an orphan drug accelerator building a glide-way for therapies targeting monogenic diseases. Read More
A year after anti-GM-CSF monoclonal antibody KB003 failed in a phase II severe asthma study, Kalobios Pharmaceuticals Inc. once again found itself shifting priorities on news of the phase II miss for its second lead product, anti-PcrV monoclonal antibody fragment KB001-A, in treating Pseudomonas aeruginosa (Pa) lung infections in cystic fibrosis (CF) patients. Read More
HONG KONG – The speed of approvals of biotechnology products in China remains a bone of contention for trade authorities in the U.S., even though "progress was made on some meaningful issues" in terms of market access within the second largest economy in the world in 2014. Trade authorities in the U.S. also have concerns surrounding patents and technology transfers for the pharmaceutical industry. Read More
Scientists have identified a new antibiotic that showed activity against several vexing bacteria in mouse studies, including methicillin-resistant Staphylococcus aureus (MRSA) and multidrug-resistant tuberculosis (MDR-TB). Read More
Little more than six months after opening at $20 after pricing its initial public offering, Zafgen Inc. impressed investors by reporting that beloranib, its methionine aminopeptidase 2a (MetAP2) inhibitor, met the primary efficacy endpoint of weight reduction in a small phase II trial in patients with hypothalamic injury associated obesity, or HIAO. Read More
Rare diseases and equally rare financing success earmark Synageva Biopharma Corp., which added more proof of investor hunger in the space by pricing its public offering of 3 million shares at $94.19 each to garner about $282.5 million. Read More