Eisai Inc., of Woodcliff Lake, N.J., the U.S. subsidiary of Tokyo-based Eisai Co. Ltd., said data from the phase III REFLECT trial testing Lenvima (lenvatinib mesylate) in 954 patients with unresectable hepatocellular carcinoma were published in The Lancet. Lenvima produced a median overall survival of 13.6 months compared to 12.3 months for Nexavar (sorafenib, Bayer AG). Read More
Acorda Therapeutics Inc., of Ardsley, N.Y., reported Ampyra (dalfampridine) extended-release tablets, 10 mg, indicated to help improve walking in adults with multiple sclerosis (MS), achieved net revenue of $167.2 million for the quarter ending Dec. 31, 2017, compared to $132.3 million for the same quarter in 2016. Read More
Active Biotech AB, of Lund, Sweden, said it is planning a rights issue of approximately SEK48 million (US$6 million). When implemented, existing shareholders will be entitled to subscribe for the new shares with preemptive rights, with two existing shares entitling a holder to subscribe for one new share at SEK1 per share. Read More
HONG KONG – The IND filed by Immuneoncia Therapeutics Inc. for its anti-PD-L1 candidate received a speedy approval from the South Korean Ministry of Food and Drug Safety (MFDS), setting the stage for initiation of clinical trials. Read More
PERTH, Australia – In 2017, Australia's Therapeutic Goods Administration (TGA) approved the lowest number of new molecular entities since 2012 – just 34, compared to 42 in 2016 and 45 in 2015. Read More
FDA experts are teaming up with patients to help drug developers explore one of the final frontiers in the human body as they seek new cures and therapies for neurological diseases. Read More
At the WORLD Symposium on lysosomal diseases in San Diego this month, Ultragenyx Pharmaceutical Inc. made a splash with data related to Mepsevii (vestronidase alfa-vjbk, previously UX-003), the company's first drug to win approval. Read More
Tosk Inc., of Mountain View, Calif., said it received a two-year, $2 million phase II Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) to support its kRAS oncogene drug R&D program. Read More
