PARIS – At the International AIDS Society's 2017 meeting on HIV science, data from the APPROACH vaccine trial that were presented in Monday's symposium on translational vaccinology were the most salient example of why there is what National Institute of Allergy and Infectious Diseases Director Anthony Fauci termed "a very cautious optimism" that despite decades of unsuccessful attempts, a vaccine is ultimately possible. Read More
The FDA issued guidance Monday on dealing with informed consent in clinical trials that involve no more than minimal risk to subjects, in keeping with a provision in the 21st Century Cures Act. Read More
Evotec AG, of Hamburg, Germany, said it advanced a drug into phase I development under its multitarget endometriosis alliance with Leverkusen, Germany-based Bayer AG, triggering an undisclosed milestone payment to Evotec, which is also eligible for other clinical and sales milestones as well as royalties on net sales. Read More
Mitsubishi Tanabe Pharma Corp. is buying Israel-based Neuroderm Ltd., the developer of a belt-worn pump for the continuous delivery of liquid levodopa/carbidopa to treat severe Parkinson's disease (PD), for $1.1 billion in cash, or $39 per share. Read More
Nektar Therapeutics Inc. continued its string of partnerships by hooking Eli Lilly and Co. as a collaborator to co-develop NKTR-358, a candidate advanced from inception to the clinic in a mere 15 months. Terms call for Nektar, of San Francisco, to receive $150 million up front with the potential for up to $250 million in additional development and regulatory milestones. Read More
"Playing chess with the disease" is how CEO Steve Worland describes Effector Therapeutics Inc.'s approach, a translational regulation strategy in cancer that bagged the San Diego-based company $38.6 million in series C money. Read More
HONG KONG – The Chinese drug registration authority has approved the phase III trial of a cancer drug in the first open meeting it ever held, clearing the way for late-stage testing of an oncolytic immunotherapy drug developed by Korean biopharma company Sillajen Inc. and its Chinese partner, Lee's Pharmaceutical Holdings Ltd. Read More
HONG KONG – Hong Kong-listed company Uni-Bio Science Group Ltd. now has Chinese conglomerate Heungkong Group as a strategic shareholder as it works to expand its distributing network, build biotech incubation centers and search for international M&A deals. Read More
Sarepta Therapeutics Inc., of Cambridge, Mass., said it is offering to sell, subject to market and other conditions, $250 million in shares of its common stock in an underwritten public offering. Read More
Orchard Therapeutics Ltd., of London, won an FDA rare pediatric disease designation to OTL-101, its lead program for the treatment of adenosine deaminase severe combined immunodeficiency, a rare inherited disorder caused by mutations in the gene encoding for the enzyme adenosine deaminase that result in a severe deficiency in white blood cells and life-threatening infections. Read More
Janssen Sciences Ireland UC, of Cork, Ireland, a unit of Johnson & Johnson, said a regimen of two investigational long-acting, injectable formulations of HIV medicines – Janssen's rilpivirine and Viiv Healthcare's cabotegravir – given together every four or eight weeks was as effective as three-drug oral antiretroviral therapy at maintaining HIV-1 viral suppression through 96 weeks (HIV-1 RNA Read More
