Clovis Oncology Inc. has more work to do before its lung cancer drug, rociletinib, is ready for approval, the FDA's Oncology Drugs Advisory Committee (ODAC) said Tuesday. Read More
Abbvie Inc.'s chief scientific officer Michael Severino told BioWorld Today that "a dedicated group of scientists who really understood the biology and how to use the tools" worked for two decades to come up with Venclexta (venetoclax), which won accelerated approval by the FDA Monday for patients with chronic lymphocytic leukemia (CLL) who exhibit the 17p deletion. Read More
Intellia Therapeutics Inc., a gene-editing start-up that filed for a proposed $120 million IPO on Monday, added a new partnership with Regeneron Pharmaceuticals Inc. The six-year deal, focused on discovery and development of CRISPR/Cas9-based products, carries a $75 million up-front fee for Cambridge, Mass.-based Intellia, plus a promised $50 million equity investment, potential milestone payments of up to $320 million per target and possible royalties. Read More
DUBLIN – Forbion Capital Partners raised €183 million (US$208 million) for its third fund, Forbion Capital Fund III (FCF III), taking its total funds under management to about €700 million. Read More
One of the most formidable challenges facing start-ups – indeed, facing the drug development community as a whole – is how to translate a promising scientific approach into a therapy that's not only safe and effective but easy to use. Over the past 10 days, Antegrin Therapeutics LLC showed that it may have checked that important box. Read More
HONG KONG — A new system developed by Australian scientists for generating induced multipotent stem (iMS) cells could result in stem cell therapies for regenerating any human tissue becoming available in the near future, with clinical trials slated to begin in orthopedic patients as early as next year, if the new technique first proves safe and effective in mice. Read More
Qu Biologics Inc., of Vancouver, British Columbia, said it closed a private financing of C$4 million (US$3.1 million), bringing the total private equity capital raised to C$23 million to date, including more than C$7 million in the last 12 months. Read More
Affibody AB, of Solna, Sweden, said it has signed a research license and product option agreement regarding IL-17-targeting molecules in ophthalmology with an unnamed partner. The company is developing four programs. The first three are therapeutics for the prevention of Alzheimer's disease, autoimmune diseases and psoriasis, respectively. The fourth program is a diagnostic imaging program that is directed primarily toward metastatic breast cancer. Read More
Symphogen A/S, of Copenhagen, said the first patient was dosed in a phase I dose-escalation study of Sym015, a mixture of two antibodies targeting the MET receptor, in patients with solid tumors. An expansion cohort will follow in a subset patient population with a pre-identified gene signature. Read More
