Alder Biopharmaceuticals Inc., of Bothell, Wash., is set to report data from a randomized, double-blind, placebo-controlled, proof-of-concept trial of ALD403, a genetically engineered monoclonal antibody targeting CGRP, for the prevention of frequent episodic migraine at the American Headache Society meeting in Los Angeles. Read More
Roche AG, of Basel, Switzerland, said it made a strategic investment in Stratos Genomics Inc., of Seattle, and entered a research collaboration to support further development of the firm's chemistry applied to single molecule sequencing of DNA fragments using protein nanopores. Read More
Acorda Therapeutics Inc., of Ardsley, N.Y., said it received a Paragraph IV certification advising that Actavis Laboratories FL Inc., a unit of Dublin-based Actavis plc, submitted an abbreviated new drug application to the FDA seeking permission to manufacture and market a generic version of multiple sclerosis drug Ampyra (dalfampridine) extended-release tablets 10 mg. Read More
Karyopharm Therapeutics Inc., of Natick, Mass., said it commenced a public offering of 2.2 million shares of common stock, with 2 million shares offered by the company and 200,000 shares offered by existing stockholders. Read More
SHANGHAI – Jiangsu Hengrui Medicine Co. Ltd., of Lianyungang and Shanghai, won FDA approval for its third cancer drug, oxaliplatin, an alkylating agent used to treat colorectal cancer, as the firm's pioneering efforts as a Chinese pharma to pass the hurdles of developed markets begin to pay off. Read More
LONDON – A study in mice suggests that it may be possible to develop a vaccine to protect against recurrence of glioma, a type of brain cancer. Researchers in Germany hope to begin phase I trials of the vaccine in early 2015. Read More
SAN DIEGO – At the BIO International Convention, BIO Ventures for Global Health (BVGH) announced a partnership with the National Universities Commission (NUC) of Nigeria to place Nigerian academics at pharmaceutical and biotech companies. Read More
SAN DIEGO – With one lawsuit by Abbvie Inc. settled out of court and another by Intermune Inc. pending, the skirmish over what's been hailed as a new era of clinical trial transparency in Europe seems likely to heat up more, as a centrally located database will make available results to just about anyone who asks, said Alexander Ehlers, an attorney with Ehlers Ehlers & Partner in Munich. Read More
SAN DIEGO – Gail Maderis, president and CEO of Baybio, introduced a session on partnerships between industry and disease foundations at the BIO International Convention with a question: Looking to the future, where do companies see those partnerships moving? Read More
HONG KONG – A Japanese technology company has reached an agreement with a UK-based orphan drug developer to co-develop and sell an orphan drug in Japan. Japan´s Teijin Pharma Ltd. entered an exclusive development and sales agreement with Sigma-Tau Pharmaceuticals Inc. that will allow Teijin to participate in the development of EZN-2279, a therapeutic agent for adenosine deaminase (ADA) deficiency, as well as to distribute the final product in Japan. Read More
Abbvie Inc., of North Chicago, said it started a phase III trial of veliparib (ABT-889), its PARP inhibitor, in combination with carboplatin and paclitaxel in patients with advanced breast cancer. Read More
