Biodelivery Sciences International Inc., of Raleigh, N.C., reported that its net revenue for Bunavail (buprenorphine and naloxone) buccal film in the fourth quarter of 2015 increased 29 percent to $1.5 million compared to the third quarter of the year. Read More
DUBLIN – Shares in GW Pharmaceuticals plc surged more than 130 percent in London on Monday on news that Epidiolex (cannabidiol) met the primary endpoint of a pivotal phase III trial in Dravet syndrome, a rare and severe form of treatment-resistant epilepsy that emerges in infancy. Read More
A proposed guidance intended to help sponsors of proteins see their way forward as the FDA transitions the drugs from the 505 path of small-molecule products to 351 biologics license applications (BLAs) could trip up a lot of development plans and open newer drugs to competition much earlier than expected. Read More
LONDON – Cambridge Epigenetix Ltd. raised $21 million in a series B to advance its epigenome sequencing technology, and has appointed Geoff Smith, former vice president of product development at Illumina Inc., CEO. Read More
Caladrius Biosciences Inc.'s worldwide, three-pronged cell-therapy technology deal through a subsidiary with Tokyo-based Hitachi Chemical Co. Ltd. not only brings money aboard but also could help snag a partner in Japan for the firm's CD34 ischemic-repair bid, communications director Eric Powers told BioWorld Today. Read More
HONG KONG — Two Asian studies published online in the March 9, 2016, issue of Nature reported the successful transplantation of cultured corneal tissue to restore vision in blinded rabbits and the regeneration of transparent lens tissue in children, demonstrating the regenerative therapeutic potential of culturing ocular tissues from stem cells. Read More
Based, in part, on the perseverance of founder Andrew Ritter, Ritter Pharmaceuticals Inc. has gutted out development of its only disclosed asset, RP-G28, for the treatment of lactose intolerance. Read More
Imprimis Pharmaceuticals Inc., of San Diego, said it will conduct a proposed underwritten public offering of its common stock, subject to market and other conditions, and also intends to grant the underwriters the option to purchase additional shares equal to up to 15 percent of the aggregate number of shares sold in the offering to cover overallotments. Read More
MSD KK, of Tokyo, on March 11 filed an application for approval of two oral agents for chronic hepatitis C elbasvir and grazoprevir hydrate in Japan. Elbasvir, an NS5A inhibitor, and grazoprevir hydrate, an NS3/4A protease inhibitor, are once-daily oral antiviral agents developed as agents for genotype 1 chronic hepatitis C with or without compensated cirrhosis. In the U.S., Zepatier, an oral combination agent of elbasvir and grazoprevir hydrate, was approved in Jan. 28, 2016, by the FDA for the treatment of genotype 1 and 4 chronic hepatitis C with or without compensated cirrhosis as monotherapy or in combination with ribavirin. (See BioWorld Today, Feb. 1, 2016.) Read More
Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., said it has entered an agreement to acquire all the assets of Bioject Medical Technologies Inc., of Tigard, Ore. Inovio said it plans to pay $5.5 million in cash and stock for the assets, which include needle-free jet injection technology, devices and intellectual property. Inovio said it plans to facilitate preventive immunizations with its DNA vaccines using Bioject's jet injection technology combined with Inovio's new needle-free, skin-surface EP (electroporation) technology. Read More