Herantis Pharma plc, of Helsinki, Finland, started recruitment for its phase I testing CDNF in 18 patients with Parkinson's disease. The trial will compare the safety and efficacy of CDNF, a natural protein with neuroprotective and neurorestorative properties, to placebo. Read More
Cascadian Therapeutics Inc., of Seattle, said the FDA granted orphan drug designation to its small-molecule kinase inhibitor, tucatinib, to treat HER2-positive metastatic colorectal cancer. Read More
Intra-Cellular Therapies Inc., of New York, said it has started an underwritten public offering of $150 million of shares of its common stock and will grant the underwriters a 30-day option to purchase up to an additional 15 percent of the shares of common stock offered in the public offering. J. P. Morgan Securities LLC and Leerink Partners LLC are acting as joint book-running managers for the offering. Read More
As of next week, drug sponsors wanting to use a pediatric or tropical disease priority review voucher (PRV) to trim four months off an FDA review time will have to pay $2,830,579 in addition to other PDUFA application fees. Read More
To uncover the mission of GRO Biosciences Inc., one has to look no further than its name. The acronym stands for "genomically recoded organisms" and describes the way in which the Boston-based startup seeks to go beyond the standard 20 amino acids to rewrite the genomes of bacterial strains to produce therapeutics with improved profiles. Read More
BOSTON – The "softer side of negotiation" was among topics covered during Biopharm America's second day, where Anjan Aralihalli, chief business officer of Glypharma Therapeutic Inc., of Montreal, asked attendees: "Are humans rational? Are we like Spock, where we think very rationally, or are we more like Homer Simpson?" Economic policy, he said, is "all premised on the underpinning that we think and make decisions rationally, but we don't." Read More
Preliminary data on three additional patients enrolled in a small open-label study of Immune Pharmaceuticals Inc.'s bertilimumab, an experimental treatment for the rare blistering disease bullous pemphigoid (BP), continued to suggest it may offer an effective alternative to systemic corticosteroids, a standard but imperfect therapy for the condition. Immune, which is seeking an FDA orphan designation for the candidate, expects to complete the proof-of-concept study and report final results in early 2018. Company shares (NASDAQ:IMNP) rose 16.7 percent to $1.40 by Wednesday's close. Read More
LONDON – The EMA has issued a warning that it risks "permanent damage to the system" as a result of its forced relocation from London after the U.K. leaves the EU in March 2019. Read More
HONG KONG Amgen Inc. and Simcere Pharmaceutical Group have entered into an agreement to develop and commercialize four biosimilars for the Chinese market. Read More
DUBLIN – For too many cancer patients, therapy still means no more than prolonging the inevitable. Cancer drug developers are proud to trot out numbers detailing objective response rates to novel drug candidates, along with progression-free survival and overall survival data. They're not shy about charging high prices for their product offerings either. But the grim reality is that five-year survival rates for many cancers – including lung, liver and esophageal – are still well below 50 percent, even if cancer death rates continue to decline in the U.S. and other high-income countries. Read More
SUZHOU, China – At the 3rd DIA China Drug Discovery Innovation this week a director from the Ministry of Science and Technology (MOST) outlined the government's proposed plans to accelerate approvals for the collection of human genetic resources in keeping with the central government's overall strategy to support innovative drug development. Read More
