A pair of top-line datasets from what analysts called a successful phase III trial in allergic conjunctivitis and a phase IIb study said to have done its job in glaucoma/ocular hypertension (OH) apparently didn't convince investors in Ocular Therapeutix Inc., who took shares (NASDAQ:OCUL) down 52.3 percent Friday, or $7.88, to close at $7.18. Read More
Members of the FDA's arthritis drugs advisory committee on Friday voted 10-4 in favor of recommending that the agency approve a new drug application (NDA) for lesinurad, a gout drug developed by Astrazeneca plc subsidiary Ardea Biosciences Inc. to improve upon standard-of-care treatment for the condition. Read More
Shares of Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) fell to a one-year low of $4.89 Friday morning after the company said it received a complete response letter (CRL) from the FDA on Evomela (melphalan). The high-dose intravenous formulation of Captisol-enabled (CE) melphalan is designed as a conditioning treatment prior to autologous stem cell transplantation (ASCT) in patients with multiple myeloma (MM). Read More
Enterococcus faecalis is one of the microbiome's two-faced members. A common member of the commensal microbiome, it can cause serious infections if it manages to outcompete other members of the gut microbiome and subsequently invade other parts of the body, such as the bloodstream, the skin or surgical sites. Read More
DUBLIN – Shares in Celyad SA rose almost 18 percent Friday on news of a U.S. patent grant covering the use of allogeneic cells in the development of therapies based on T cell receptor-deficient T cells engineered to express chimeric antigen receptors (CARs). Read More
Kiyatec Inc., of Greenville, S.C., an SCRA Technology Ventures company, said it received a Fast Track Phase I and Phase II Small Business Innovation Research contract for $1.725 million from the National Cancer Institute. The goal is to develop culture systems that can grow and maintain the rare population of cancer stem cells, which are believed to lead to therapy resistance, relapse and death from metastatic disease. Kiyatec's focus is small-cell lung cancer. Read More
Oasmia Pharmaceutical AB, of Uppsala, Sweden, gained a Nasdaq listing and raised $9.3 million by offering 2.3 million American depositary shares (ADSs) at $4.06 apiece, below its earlier range of $4.70 to $6.70. The offering also included 1.1 million warrants with an exercise price of $4.06 per ADS. Oasmia, which also trades on the Nasdaq Stockholm exchange, develops new formulations of existing chemo drugs for use in humans and dogs. Read More
Scientists from the Novartis Institutes for Biomedical Research have retrospectively validated the idea that patient-derived xenografts of tumors are better preclinical models to study cancer drug responses than cell lines. Previous experiments have shown that such xenografts accurately recapitulated drug responses and resistance mechanisms in patients, but few such models have been established. Read More
LONDON – Another landmark has been reached in cancer immunotherapy with the EMA recommending approval of the first oncolytic virus, Amgen Inc.'s Imlygic (talimogene laherparepvec), for the treatment of nonresectable metastatic melanoma. Read More
Fibrogen Inc., of San Francisco, and partner Astrazeneca plc, of London, said the Journal of the American Society of Nephrology published phase II data showing roxadustat, an investigational therapy for the treatment of anemia in patients with chronic kidney disease (CKD), achieved 96 percent hemoglobin (Hb) response and increased mean Hb regardless of baseline iron repletion status, C-reactive protein level, iron regimen or dialysis modality within seven weeks. Read More
