Following the Senate Finance Committee's second hearing on prescription drug prices Tuesday, U.S. lawmakers, at least some of them, may change their tune on the rebate reforms the administration has proposed. Read More
Karyopharm Therapeutics Inc.'s lead agent, selinexor, endured a tough hearing before the FDA's Oncologic Drugs Advisory Committee Tuesday, leading agency advisors to ultimately vote 8-5 in favor of delaying approval until the results of the randomized phase III trial, BOSTON, are available. The outcome could delay selinexor's potential approval by about two years. Read More
Douglas Kahn, CEO of Tetragenetics Inc., told BioWorld that his firm "in pretty short order went from introducing the technology to discussing the terms of a potential relationship" for the purpose of developing non-opioid pain drugs with Imbrium Therapeutics LP, a subsidiary of Purdue Pharma LP, the embattled maker of Oxycontin (oxycodone). Read More
LONDON – Researchers in the U.K. are moving ahead with plans for a phase III study of glial-derived neurotrophic factor (GDNF) in Parkinson's disease, after overcoming the obstacles to repeated delivery of the drug directly into the brain that confounded previous studies. Read More
HONG KONG – Chinese drug regulators have approved the first homegrown biosimilar, Shanghai Henlius Biotech Inc.'s HLX-01, a biosimilar referencing Roche Holding AG's Mabthera (rituximab), to treat non-Hodgkin lymphoma (NHL). It will be marketed as Hanlikang. Read More
DUBLIN – The concept of harnessing interleukin-2 (IL-2) signaling to boost immune responses to cancer is almost as old as the biotechnology industry. Up until now, however, the idea has only been imperfectly realized because of the limitations of using recombinant IL-2. Read More
PTC Therapeutics Inc., of South Plainfield, N.J., said the sole underwriter of its January public offering of 6.72 million shares partially exercised its option to purchase additional shares, increasing the total offering to about 7.6 million shares. PTC's aggregate net proceeds are expected to total about $224.1 million. RBC Capital Markets acted as the sole book-running manager. Read More
Clovis Oncology Inc., of Boulder, Colo., reported 2018 U.S. sales of PARP inhibitor Rubraca (rucaparib) totaling $95.4 million, including $30.4 million for the fourth quarter. The company reported a net loss of $99.3 million, or $1.88 per share, for the fourth quarter, and a net loss of $368 million, or $7.07 per share, for the full year. As of Dec. 31, Clovis had cash, equivalents and available-for-sale securities of $520.1 million. Shares of Clovis (NASDAQ:CLVS) closed Tuesday at $26.05, up 58 cents. Read More
Axim Biotechnologies Inc., of New York, said it successfully microencapsulated cannabinoids into its patented chewing gum delivery mechanism for use in its proposed clinical trials. Read More
