It's been a long road for regenerative medicine pioneer Ocata Therapeutics Inc., founded in 1994 as Advanced Cell Technology Inc. (ACT), where one of its earliest deals was a $10 million collaboration with Genzyme Transgenics Corp. to create cloned cows capable of producing human serum albumin in their milk. (See BioWorld Today, Oct. 9, 1997.) Read More
One month after reporting enhanced overall survival (OS) in a pivotal study and one day before its PDUFA date, Genentech Inc.'s cobimetinib, branded Cotellic, was approved by the FDA for use in combination with Roche AG's Zelboraf (vemurafenib) to treat locally advanced or metastatic melanoma carrying a BRAF V600E or V600K mutation – subtypes that account for roughly half of the population of patients with melanoma. Read More
Re-tooled Amplyx Pharmaceuticals Inc. garnered $40.5 million in series B funding for antifungal work with APX001, a new-mechanism therapy licensed from "an established pharma company" that "for strategic reasons decided to focus on later-stage programs," CEO Mike Grey told BioWorld Today. Read More
Defying low expectations set almost a year ago by an interim peek at phase III data, Sophiris Bio Inc.'s PRX302 (topsalysin) rose to meet its primary endpoint of statistically significant improvement of benign prostatic hyperplasia (BPH) symptoms over 12 months in final data released Tuesday. Read More
SHANGHAI – Acea Biosciences Inc., a company that got its start selling instruments used for drug discovery and along the way developed its own pipeline of novel drug compounds, has just closed its first venture round, receiving $30 million from Lilly Asia Ventures and Qiming Venture Partners. Acea is headquartered in San Diego with an instrument plant and additional operations in Hangzhou, Zhejiang. Read More
BOSTON — The Molecular Targets meeting, a joint endeavor of the American Association for Cancer Research, the National Cancer Institute, and the European Organisation for Research and Treatment of Cancer (AACR-NCI-EORTC), wrapped up a lively four days on Monday with a discussion of "the in vitro patient." Read More
HONG KONG – To tackle the high prevalence of cholangiocarcinoma in South Korea, two companies have come together in a co-development deal to bring the first treatment to the country. Read More
Miragen Therapeutics Inc., of Boulder, Colo., said it raised $41 million in gross proceeds from a series C preferred stock financing, including conversion of outstanding notes. Miragen plans to use the proceeds to advance two product candidates, MRG-106 and MRG-201, into clinical development this year. Read More
Kineta Inc., of Seattle, said the Alliance for Children's Therapeutics, a pediatric research collaboration between Seattle Children's Research Institute and the company, reported updated, positive data from research efforts using Kineta's lead drug dalazatide, formerly ShK-186, for lupus nephritis. Read More
Boehringer Ingelheim GmbH, of Ingelheim, Germany, said it completed enrollment in the pivotal phase III study of BI695501, a biosimilar candidate to adalimumab (Abbvie Inc.'s Humira). Read More