The peptide rhesus theta-defensin (RTD-1) was able to arrest and reverse rheumatoid arthritis (RA) in a rodent model. Theta-defensins are a class of peptides that are expressed by old world monkeys and dampen innate immunity via multiple mechanisms. Read More
The Patient-Centered Outcomes Research Institute Board of Governors in Washington has approved $57 million to fund 14 new comparative clinical effectiveness research studies. Read More
Diamedica Therapeutics Inc., of Minneapolis, received ethics committee approval to initiate the first clinical site for its phase II Remedy trial with DM-199 (recombinant human kallikrein 1). Read More
Puma Biotechnology Inc., of Los Angeles, and Specialised Therapeutics Asia Pte Ltd., of Singapore, entered an exclusive agreement under which Specialised Therapeutics will commercialize Nerlynx (neratinib) throughout Southeast Asia, beginning with Australia, Singapore, Malaysia, Brunei and New Zealand. Read More
Kalytera Therapeutics Inc., of San Francisco, signed an agreement with Echelon Wealth Partners Inc. to lead a brokered best efforts private placement of up to $5 million of convertible debenture units at a price of $1,000 per unit. Read More
"'Outpost' connotes a small force out on the frontier," Scott Byrd, newly named president and CEO of Outpost Medicine LLC, explained. It's a moniker the company takes seriously. Read More
In mouse models, certain mutations in T cells synergized with PD-1 blockade to spur uncontrolled growth, resulting in T-cell lymphomas. Jürgen Ruland, a professor of clinical chemistry and pathobiochemistry at the German Technical University of Munich and senior author of the paper reporting the findings, told BioWorld that his team was as surprised as anyone by the results. Read More
HONG KONG – Samsung Bioepis Co. Ltd. has received approval in both South Korea and Europe for its Herceptin biosimilar. Known as Samfenet in South Korea and as Ontruzant in Europe, it marks the first Herceptin biosimilar to be approved by the European Commission. Read More
Immuno-oncology drugs Keytruda (pembrolizumab, Merck & Co. Inc.) and Opdivo (nivolumab, Bristol-Myers Squibb Co.) came in first and third in the latest edition of the Trinity Drug Index, with hepatitis C drug Harvoni (sofosbuvir/ledipasvir, Gilead Sciences Inc.) taking the second spot. This version of the annual index scores the 41 drugs approved by the FDA in 2014 based on commercial, therapeutic and R&D categories. Read More
The amount of money that the biopharma sector invests in research and development (R&D) continues to rise. Innovation certainly does not come cheap; it requires that companies developing breakthrough medicines have deep pockets as they need to invest up to $2.5 billion over a 10- to 15-year period in order to bring a new therapy to the marketplace, according to the most recent analysis by the Tufts Center for the Study of Drug Development of the average cost to develop and gain marketing approval for a new drug. Read More
