LONDON – Gammadelta Therapeutics Ltd. has leapt from virtual startup last September to land a $100 million equity, R&D funding and option-to-buy deal with Takeda Pharmaceuticals Co. Ltd. Read More
Novelion Therapeutics Inc., of Vancouver, British Columbia, reported financial results for the first quarter, with total net revenues of $30 million consisting of net revenues from Myalept (metreleptin), for generalized lipodystrophy, of $14 million – with $11.5 million from U.S. prescriptions – and net revenues of $16 million from sales of Juxtapid (lomitapide), a microsomal triglyceride transfer protein blocker for homozygous familial hypercholesterolemia, with $10.9 million derived from U.S. prescriptions. Read More
Santalis Pharmaceuticals Inc., of San Antonio, said it enrolled the first U.S. subject in a phase II, placebo-controlled, double-blind, safety, tolerability and efficacy study of a 5 percent sandalwood album oil, also known as East Indian sandalwood oil, cream formulation for the treatment of atopic dermatitis. Subjects will be 18 to 65 years old with a clinically stable diagnosis of atopic dermatitis with a total body surface area involvement of 2 percent to 15 percent. Up to 60 subjects will be enrolled to determine preliminary efficacy after 28 days of twice-a-day treatment. Read More
Aptose Biosciences Inc., of San Diego, reported preclinical data at the American Association for Cancer Research conference in Boston demonstrating that CG'806, a pan-FLT3/BTK inhibitor, exerts activity against acute myeloid leukemia (AML) cells harboring mutant forms of FLT3 and eradicates AML tumors in a murine xenograft model. Read More
Nantcell and Nantkwest Inc. have gained FDA permission to start enrolling a phase Ib/II trial of the Nant cancer vaccine, a step toward what Nantkwest CEO Patrick Soon-Shiong has said is a quest to develop a vaccine intended to induce immunogenic cell death and orchestrate patients' innate and adaptive immune systems. Read More
CHICAGO – After gaining approval in January for Trulance (plecanatide) to treat chronic idiopathic constipation (CIC), Synergy Pharmaceuticals Inc. wasted little time posting the complete phase III dataset on a bigger win sought in irritable bowel syndrome with constipation (IBS-C). Read More
A Senate committee will meet May 10 to mark up legislation for the FDA user fee programs, and one of the more significant features of the so-called manager's mark of the legislation is that it calls on the agency to facilitate the use of "foreign clinical trial data to minimize duplicative clinical trials." Read More
PERTH, Australia – The TGA is seeking industry comments on its proposal to beef up sanctions and penalties as part of its overhaul of drug and device regulations. Some of the proposals relate to suggestions from the expert panel review that would introduce public warnings for advertising noncompliance. Read More
Noting the potential of gene-editing with CRISPR/Cas9, the U.S. Congressional Research Service (CRS) released a report to help the 115th Congress grapple with questions that may come up over the next two years concerning the ethical, social and legal implications of CRISPR-related biotechnology products. Read More
Cytokinetics Inc., of South San Francisco, said it priced an underwritten public offering of 5.26 million shares of its common stock at $14.25 each, with gross proceeds expected to be approximately $75 million. Read More
