Cipher Pharmaceuticals Inc., of Mississauga, Ontario, acquired the Canadian rights to distribute and commercialize A-101, 40 percent topical solution, from Aclaris Therapeutics Inc., of Malvern, Pa. Read More
Mannkind Corp., of Westlake Village, Calif., said it priced a registered direct offering of 14 million shares and warrants to purchase up to 14 million additional shares. Read More
After conducting a meta-analysis of the supporting preclinical application materials submitted to institutional review boards (IRBs) for more than 100 clinical trials, researchers at the German Hannover Medical School found that those application materials were deficient in the vast majority of applications, to the point that "poor [preclinical efficacy studies] design and reporting thwart risk/benefit evaluation during ethical review of phase I/II studies." Read More
With multiple first-time clinical data readouts due this year, some of which – in the view of Raymond James analyst Reni Benjamin – could "transform the company," immuno-oncology (I-O) player Leap Therapeutics Inc. is readying for the first round at the American Association of Cancer Research (AACR) meeting in Chicago starting Saturday. Read More
HONG KONG – A neural plasticity enhancer, edonerpic maleate, could be the first clinically effective compound for accelerating rehabilitation after brain damage, potentially revolutionizing the future management of stroke patients, according to the results of a new Japanese study reported in the April 6, 2018, edition of Science. Read More
LONDON – Shield Therapeutics plc has pulled back from the brink after the FDA weighed up a revised analysis of its phase III trial of the iron replacement therapy Feraccru in patients with chronic kidney disease (CKD), and told the company it does not need to conduct further trials before submitting a new drug application (NDA). Read More
In three sentences, Incyte Corp. and Merck & Co. Inc. threw the immuno-oncology (I-O) world into a tailspin, revealing that the pivotal phase III ECHO-301/KEYNOTE-252 study evaluating Incyte's epacadostat in combination with Merck's Keytruda (pembrolizumab) in individuals with unresectable or metastatic melanoma failed a review by the external data monitoring committee (DMC). Read More
LONDON – A group of senior U.S. oncologists is looking to raise $4 million to $5 million for a 300-patient study to demonstrate whether the effective dose of Zytiga (abiraterone) can be reduced by 75 percent if the orally administered CYP17 inhibitor is taken with food, rather than after an overnight fast, as instructed by the label. Read More
At one time the industry would congratulate itself if it managed to raise $20 billion in a single year. Now companies appear to have no difficulty capturing that amount over a three-month period whether the financial markets are favorable or not. Read More
