The title of a proposed U.S. Department of Health and Human Services (HHS) rule that could end drug rebates in federal programs has two lawmakers pressing the White House Office of Management and Budget (OMB) to conduct a robust regulatory impact analysis of the rule before clearing it for publication. Read More
Athenex Inc., of Buffalo, N.Y., said the FDA has granted clearance for Athenex Pharmaceutical Division (APD) to import potassium chloride injection concentrate (2 mEq/mL) in response to a national drug shortage of the product to treat low blood potassium. The clearance allows APD to import the product on a temporary basis or for the duration of the shortage. Read More
Collegium Pharmaceutical Inc., of Canton, Mass., reported net product revenues totaling $73.1 million for the second quarter vs. $3.6 million for the same period in 2017. Net product revenue was $18.1 million for tamper-resistant opioid Xtampza ER (oxycodone extended-release) and $55 million for the Nucynta (tapentadol) pain drug franchise. Read More
Helix Biopharma Corp., of Richmond Hill, Ontario, closed a private placement of 682,000 units consisting of a share and a warrant to buy an additional share for C$1.20 per unit, grossing the company C$818,400 (US$627,631) that it will use for working capital and research and development activities. Shares of Helix (TSE:HBP) closed flat at C70 per share. Read More
More than two decades after founding Berlin Heart, the company's former CEO, Johannes Müller – a doctor, researcher and inventor behind that company's pioneering ventricular assist device – is leading a new company, Berlin Cures Holding AG, to attack a root cause of a common type of heart failure with a new DNA aptamer-based compound, BC-007. It enters phase II testing this summer. The trial is expected to read out by the middle of 2020. Read More
It's not news that human cancer cell lines evolve over time, but the extent to which they diverge and the implications that has for the reproducibility of preclinical research and drug screening have now been laid bare in a genomic analysis of multiple cell lines in use at laboratories around the world. Read More
HONG KONG – In a $120 million deal focused on the greater China region, Glenmark Pharmaceuticals Ltd. joined hands with China's Harbour Biomed Therapeutics Ltd. to co-develop the U.S. company's bispecific antibody (bsAb), GBR-1302, for treating HER2-positive cancers, including breast, gastric and ovarian cancers. Read More
Details were scant, and Edward Conner, senior vice president and chief medical officer at Sangamo Therapeutics Inc., cautioned that "it's obviously still early days," but the Richmond, Calif.-based company clearly is encouraged by early data from the phase I/II ALTA trial evaluating SB-525, its cDNA gene therapy candidate to treat hemophilia A. Read More
For the first time in more than 18 years, the FDA has approved a new drug for malaria prevention. Washington-based 60 Degrees Pharmaceuticals LLC (60P), which got a green light to market Arakoda (tafenoquine) tablets for adults, said the approval marks the culmination of more than 30 years of R&D with the U.S. Army Medical Research and Materiel Command, starting with the discovery of tafenoquine at the Walter Reed Army Institute of Research. Read More
