Shares of Madrigal Pharmaceuticals Inc. (NASDAQ:MDGL) rocketed 145 percent higher to $265.61 Thursday on top-line 36-week phase II nonalcoholic steatohepatitis (NASH) data for MGL-3196. The drug showed statistically significant benefits in relative reduction of liver fat, the trial's primary endpoint, and NASH resolution, an accepted FDA regulatory endpoint, fueling new interest in the company's bid to conquer the obesity-linked condition for which no medicines are currently approved. Read More
In releasing two draft guidances Thursday on shared risk evaluation and mitigation strategies (REMS), the FDA took aim at another shenanigan some brand drug companies have used to delay competition. The guidances, which discuss the development of a shared system REMS and waivers for the single, shared REMS requirement, are being touted as a way to enhance competition, one of the pillars in the administration's recently announced blueprint to reduce drug prices. Read More
CAMP4 Therapeutics is on a mission to modernize drug discovery and development, and the Cambridge, Mass.-based company just scored a $30 million series A to climb toward that goal. Read More
Following last year's phase III win in the SUMMIT-07 study of NKTR-181 in more than 600 patients with moderate to severe chronic low back pain, Nektar Therapeutics Inc. took the next step toward commercialization by submitting the new drug application (NDA) to the FDA. The San Francisco-based company is seeking to advance the mu-opioid agonist, which has shown reduced incidence of central nervous system-mediated side effects such as euphoria, along the road less traveled to set itself apart in the controversial asset class. If approved, NKTR-181 could become the first analgesic opioid molecule to exhibit reduced incidence of such effects, through targeted alteration of brain-entry kinetics. Read More
Multiple nanorobots with single functions have been developed in recent years. Now, researchers have created a single nanorobot with multiple functions. Read More
HONG KONG – China's Luye Pharma Group Ltd. has partnered up with U.S. biotech firm Elpis Biopharmaceuticals Corp. to work on dual target-based therapies for cancer patients who fail to respond to current treatment. Read More
Summer arrives with a bang for biopharma in the dueling agendas of the American Society of Clinical Oncology (ASCO) annual meeting, the BIO International Convention, Digestive Disease Week (DDW) and ASM Microbe – all packed into a 12-day period – not to mention overlapping health care conferences sponsored by several major investment banks. What's a harried insider to do? Breathe deeply, then take a gander at BioWorld's 12th annual Summer Reading List before you head to the airport for 10 days of sleep deprivation and jet lag. As always, our staff and readers from across the industry have you covered. Read More
Sisaf Ltd., of London, closed a $4.3 million interim funding round led by Vickers Venture Partners with additional capital contributions by Invest NI and Innovation Ulster Ltd. The company plans to use the investment to accelerate the development of its dermatology pipeline. Read More
Contravir Pharmaceuticals Inc., of Edison, N.J., reported findings from a preclinical study of CRV-431 indicating that the drug, a cyclophilin inhibitor, decreased the extent of fibrosis in an animal model by 46 percent compared to vehicle control. Read More
The Pharmaceutical Research and Manufacturers of America (PhRMA) responded to an analysis comparing assessments by the Institute for Clinical and Economic Review's (ICER), warning that a one-size-fits-all framework would mean that 62 percent to 93 percent of patients with serious, complex conditions would face access barriers to treatment. Read More
