Though the failure of Regeneron Pharmaceuticals Inc.’s phase II combo trial in wet age-related macular degeneration (AMD) surprised few (including, maybe, the company itself) in the shifting treatment landscape, phase III data due soon from Ophthotech Corp. with its similar pairing could change the picture yet again. Read More
Threshold Pharmaceuticals Inc. said it would discontinue development of EGFR-targeted tarloxotinib after the oncology candidate fell short of its expectations in dual phase II proof-of-concept trials. Read More
A broad swath of KRAS-mutated non-small-cell lung cancers (NSCLCs) are sensitive to the effects of blocking nuclear export, offering a possible way to drug KRAS-mutant tumors, researchers reported in the Sept. 29, 2016, issue of Nature. Read More
Investors in Aurinia Pharmaceuticals Inc. breathed a sigh of relief, and moved shares (NASDAQ:AUPH) higher, after learning that both study doses in the phase IIb AURA-LV (Aurinia Urine Protein Reduction in Active Lupus Nephritis) study of lupus nephritis (LN) candidate, voclosporin – added to standard-of-care mycophenolate mofetil and a forced oral corticosteroid taper – met 24-week pre-specified secondary endpoints compared to control. Read More
LONDON – A U.K. enquiry into the moral and ethical issues raised by genome editing has concluded existing regulations provide sufficient oversight for the majority of applications but that its potential uses in treating inherited diseases by altering the germline in humans, and to increase production in livestock, requires urgent scrutiny. Read More
PERTH, Australia – The Australian government’s release of the Review of the R&D Tax Incentive met a mixed response from the biopharma and med-tech communities operating in the country. Read More
The memo regarding prosecution of False Claims Act violations by deputy attorney general Sally Qullian Yates is roughly a year old, and a couple of cases have come through demonstrating that individual culpability is indeed the focus of federal prosecutors. Read More
The SEC charged the former senior director of regulatory affairs for Puma Biotechnology Inc., of Los Angeles, with insider trading ahead of the company’s news announcements about its drug to treat breast cancer. Read More
SQZ Biotech, of Boston, closed a $16 million series B financing led by Nanodimension and Polaris Partners, with participation from undisclosed existing and new investors. Read More
Cohbar Inc., of Menlo Park, Calif., said two analogues from its MOTS-c program have been selected for advancement into IND-enabling activities. Read More
Astrazeneca plc, of London, and its biologics research arm, Medimmune, reported that the phase III FALCON trial demonstrated superiority of Faslodex (fulvestrant) over Arimidex (anastrozole) in the first-line treatment of hormone receptor-positive advanced breast cancer. Data are being presented at the European Society for Medical Oncology in Copenhagen. Read More
Double-stranded breaks (DSBs) in DNA can lead to apoptotic cell death if they cannot be repaired satisfactorily, but how cells know when it's time to go remains unclear. Read More
