A little more than four years after striking its first deal with Aduro Biotech Inc., Johnson & Johnson's Janssen Biotech Inc. is terminating research and licensing agreements for the Berkeley, Calif.-based company's experimental lung and prostate cancer treatments. The termination leaves about $1.1 billion in potential milestone payments to Aduro unrealized, and returns three programs based on its live, attenuated double-deleted Listeria (LADD) technology platform to the company. (See BioWorld Today, Oct. 17, 2014.) Read More
Nearly two weeks ahead of its presumed PDUFA date, sarecycline, branded Seysara, was greenlighted by the FDA to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 and older. The once-daily, oral, narrow spectrum tetracycline-derived antibiotic was discovered by Paratek Pharmaceuticals Inc., which originally licensed U.S. development and commercialization rights to Warner Chilcott Ltd., which went to Actavis plc, now Allergan plc. In August, Almirall SA gained those rights in conjunction with its acquisition of Allergan's U.S. medical dermatology unit for $550 million in cash and a potential $100 million earn-out based on business performance. The transaction closed last week. Read More
PERTH, Australia – Adelaide-based Bionomics Ltd.'s lead candidate, BNC-210, failed to meet the primary endpoint of decreasing symptoms in patients with post-traumatic stress disorder (PTSD) in its phase II trial, and the company is stopping development in PTSD. Shares of Bionomics (ASX:BNO) closed Tuesday at A17 cents (US12 cents), down A33 cents, or 66 percent, on the news. Read More
The trade deal that will overwrite the North American Free Trade Agreement awaits ratification by the U.S. Senate, but while the deal offers only 10 years of biotech data exclusivity, the agreement also forbids the practice of requiring sales and pricing data for products cleared or approved in the other two jurisdictions. Read More
HONG KONG – With the U.S. approval under its belt, Verastem Inc. is looking at China as the next big market for Copiktra (duvelisib), inking an exclusive licensing deal with CSPC Pharmaceutical Group Ltd., of Shijiazhuang, China, in exchange for $15 million up front in deal for rights to develop and commercialize Copiktra for all oncology indications in China. Read More
Everyone knows real-world evidence (RWE) is part of the future for drug and device development in the U.S. But how to get there in a regulatory world where randomized controlled trials (RCTs) remain the FDA gold standard is a little less clear. Read More
Curelab Oncology Inc., of Boston, said data published in Aging demonstrates that its product, circular DNA encoding p62/SQSTM1 gene, may prevent and alleviate age-related macular degeneration, according to work performed on rapidly aging rats. Read More
The FDA is once again resorting to public shaming to advance drug competition. The agency released a revised draft guidance Tuesday that would provide a more efficient approach to 505(q), or citizen, petitions and enable staff to focus resources on product reviews. "The record shows that citizen petitions have rarely delayed specific generic drug approvals," FDA Commissioner Scott Gottlieb said, but the petition process can take resources away from product reviews. Read More
GW Pharmaceuticals plc, of London, said it intends to sell $300 million of American depositary shares (ADSs) representing ordinary shares of GW on Nasdaq in an underwritten U.S. public offering. The underwriters will be granted a 30-day option to purchase up to an additional $45 million of ADSs at the offering price. Read More
