Seattle Genetics Inc., of Bothell, Wash., reported second quarter revenues of $108.2 million, including $74.3 million in net sales of Adcetris (brentuximab vedotin) in the U.S. and Canada, compared to revenues of $95.4 million in the second quarter of 2016. Read More
Idorsia Ltd., of Allschwil, Switzerland, reported that the phase II program of its dual orexin receptor antagonist (DORA), known as ACT-541468, met its primary endpoint in insomnia, using zolpidem as an active comparator. Read More
Tiziana Life Sciences plc, of London, said preclinical data for foralumab (NI-0401), an oral anti-CD3 monoclonal antibody, was published in Clinical Immunology. Read More
A potent new anti-Zika virus peptide that appears to be safe and reduces viral levels in pregnant mice and their fetuses, has been identified in a Chinese study published in the July 25, 2017, edition of Nature Communications. Read More
HONG KONG – After the kickback scandal involving Novartis AG, South Korean authorities are determined to root out corruption from the country's pharmaceutical sector. (See BioWorld Today, Sept. 6, 2016.) Read More
PERTH, Australia – Patients in Australia will now be able to get unapproved drugs through their doctors more quickly since Australia amended its drug and device regulations earlier this year. Read More
While recognizing that the bipartisan Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act is not a silver bullet that will bring down all drug prices, U.S. officials and several experts gave the bill high marks last week during a House Judiciary subcommittee on antitrust concerns and the FDA drug approval process. Read More
Nantcell Inc., the Patrick Soon-Shiong-backed company built in part with funds from the blockbuster albumin-bound chemotherapy Abraxane (nab-paclitaxel), has exclusively licensed Cytrx Corp.'s aldoxorubicin, another albumin-bound therapy, to incorporate into the treatment of multiple tumor types in combination with other immuno-oncology and cell-based therapies. Read More
The fog began to dissipate at least somewhat late last week regarding the reasons behind – and the potential immuno-oncology (IO) fallout from – Astrazeneca plc's phase III blowup with the MYSTIC trial in non-small-cell lung cancer (NSCLC), news of which came just as the pharma giant made public its $8.5 billion deal with Merck & Co. Inc. around the oral poly ADP ribose polymerase (PARP) inhibitor Lynparza (olaparib). Read More
A cardiovascular signal that earned a second complete response letter (CRL) for Dynavax Technologies Corp.'s hepatitis B vaccine, Heplisav, was determined by members of the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) largely to be a "spurious" finding that should be investigated more fully in a required postmarketing study. Read More
