Chimerix Inc., of Durham, N.C., reported preclinical data showing direct-acting antiviral candidate CMX-521 had activity in vitro against all strains of norovirus tested. Results also showed a promising safety profile, with oral administration delivering the drug directly to target cells in the gut. Read More
Zurex Pharma Inc., of Middleton, Wis., which is developing a platform of antimicrobial products designed to minimize and prevent health care-associated infections, said it generated a significant capital raise ahead of its first new drug application (NDA) submission. Read More
Wanted: A couple of drug companies that will lower their list prices, bucking the current U.S. system that's based on rebates lining the pockets of everyone but patients. Read More
An oligonucleotide-based TLR antagonist developed by Idera Pharmaceuticals Inc. to treat adults with the rare inflammatory disease dermatomyositis (DM) has failed to best a placebo on a common measure of disease severity, missing the phase II trial's primary endpoint. The shortfall for Idera's IMO-8400 opens the field for the mid-stage cannabinoid receptor type 2 agonist, lenabasum, in development at Corbus Pharmaceuticals Holdings Inc., and other DM programs as Idera turns its attention more fully to advancing its lead program, tilsotolimod, for melanoma and other tumor types, and its proposed merger with Biocryst Pharmaceuticals Inc. Read More
With one biopharma set to price its IPO this week, three others – neurology-focused Aptinyx Inc., stem cell gene therapy firm Avrobio Inc. and specialty pharma Xeris Pharmaceuticals Inc. – have set terms for their anticipated offerings, putting the sector on track to match last year's IPO activity, at least in terms of number of offerings. In terms of money raised, however, the first half of 2018 looks like it might top the amount raised in global IPOs priced in the first half of 2017. Read More
LONDON – Targovax ASA's plan to start a pivotal trial of its pancreatic cancer vaccine, TG-01, in the second half of 2018 has been derailed by the good news presented at the American Society of Clinical Oncology (ASCO) meeting last week that a new chemotherapy regimen extended overall survival for 20 months longer than standard-of-care gemcitabine. Read More
Sage Therapeutics Inc. came a step closer in its bid to "rewrite the textbook on how depression should be treated," CEO Jeff Jonas told BioWorld, as the FDA rubber-stamped an expedited development route for type A gamma-aminobutyric acid (GABAA) modulator SAGE-217 in major depressive disorder (MDD). "We think this is a fundamental brain mechanism" with even wider applications, he said. Read More
DUBLIN – The drug development graveyard that is Alzheimer's disease (AD) has claimed another victim, as Astrazeneca plc and Eli Lilly & Co. halted development of the beta secretase cleaving enzyme (BACE) inhibitor lanabecestat (AZD-3293; LY-3314814), after an independent data monitoring committee concluded that two phase III trials of the drug were unlikely to meet their primary endpoints. Read More
