DUBLIN – Atlantic Healthcare plc has begun recruitment onto a pivotal phase III trial of the antisense drug alicaforsen in ulcerative colitis patients with pouchitis who are refractory to antibiotic therapy. Read More
A receptor that is involved in mediating the effects of stress and anxiety in the brain also plays a role in the spinal cord, where it is important in the development of chronic pain. Read More
Transcelerate Biopharma Inc., a nonprofit established by 10 of the industry's largest pharmas in 2012, is launching Biocelerate, a new subsidiary that aims to improve efficiencies in preclinical research, first by working to illuminate the relationship between patient response and preclinical toxicology findings. Read More
Patience, persistence and no small amount of pragmatism enabled Armo Biosciences Inc. to hit the $50 million target for its series C round, launched in September 2015 just as the capital markets soured. Read More
Alkermes plc's phase III program with the antipsychotic ALKS 3831 for schizophrenia is designed to find out whether the tablet – which combines olanzapine with the firm's opioid antagonist samidorphan – can get around the weight-gain and metabolic problems that come with olanzapine by itself. Read More
Yumanity Therapeutics pulled down a $45 million series A led by Fidelity Management & Research Co. – "the investment group, not the venture group," Tony Coles, chairman and CEO, clarified – in a vote of institutional confidence that "almost never happens" in an early round, he said. The syndicate included seed investor Redmile Group along with Alexandria Venture Investments, Biogen, Sanofi-Genzyme Bioventures and Dolby Family Ventures. Read More
Seattle Genetics Inc., of Bothell, Wash., said total revenues in the fourth quarter and year ended Dec. 31, 2015, increased to $93.5 million and $336.8 million, respectively, from $74.3 million and $286.8 million for the same periods in 2014. Read More
Mast Therapeutics Inc., of San Diego, said it priced an underwritten public offering of 29.09 million units at $0.275 each. Each unit consists of one share of the company's common stock and one warrant to purchase one share of the company's common stock at an exercise price of $0.42 per share. Read More
Cidara Therapeutics Inc., of San Diego, said the FDA granted orphan drug designation to its drug candidate, CD101 IV, for the treatment of candidemia and invasive candidiasis. Phase I data demonstrated the safety and tolerability of up to three doses of high exposure, once-weekly CD101 IV. A phase II experiment will be initiated in the first half of 2016. Read More
Citing "systemic data manipulation" and other "significant" manufacturing violations and deviations at three Ipca Laboratories Ltd. facilities in India, the FDA issued a warning letter requiring immediate action. Read More
Vtv Therapeutics Inc., of High Point, N.C., completed patient enrollment in the company's AGATA (Add Glucokinase Activator to Target A1c) study, a phase IIb trial assessing the efficacy and safety of TTP399 in patients with type 2 diabetes. TTP399 is an oral, liver-selective glucokinase activator with first-in-class potential, the firm said. (See BioWorld Today, June 17, 2015.) Read More
