Before seeking new regulatory authorities for the 340B program, the U.S. Health Resources and Services Administration (HRSA) needs to use the authority it already has, the Democrat and Republican leadership of the Senate Health, Education, Labor and Pensions Committee and the House Energy & Commerce Committee said in a letter Monday to the agency. Read More
Novaremed AG, of Basel, Switzerland, said it raised additional financing of CHF6 million (US$6.12 million) from existing shareholders and several new private investors via a rights offering, with pro-rata rights for existing shareholders. The proceeds will be used to prepare for a global phase IIb study of its lead compound, NRD.E1, a first-in-class, small molecule for patients suffering from diabetic neuropathic pain. Read More
Biocancell Ltd., of Cambridge, Mass., said it is changing its name to Anchiano Therapeutics and will now trade on the Tel Aviv Stock Exchange under the ticker symbol ANCN (formerly BICL). The company is focused on the discovery and development of therapies to treat cancer. It most advanced product candidate, inodiftagene vixteplasmid (BC-819), is in development as a treatment for non-muscle invasive bladder cancer. Read More
As we head toward the Labor Day holiday weekend, the market performance of the sector's blue chip companies have so far failed to capitalize on their welcomed surge in valuation in July. As a result they are treading water this month with the value of the BioWorld Biopharmaceutical Index up a modest 0.5 percent at last Thursday's market close compared to a 1 percent increase in the Dow Jones Industrial Average and a 3 percent jump in value for the Nasdaq Composite index. (See BioWorld Biopharmaceutical index, page 8.) Read More
PERTH, Australia – After reporting positive data at the American Society of Clinical Oncology (ASCO) meeting for its Akt inhibitor in estrogen receptor (ER)-positive breast cancer, Melbourne-based Prescient Therapeutics Pty Ltd. is poised to carve out a niche for itself across a variety of cancers. Read More
HONG KONG – Roche Holding AG was granted a rapid approval from the China National Drug Administration (CNDA) for Alecensa (alectinib). The drug was greenlighted as a monotherapy treatment for patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small-cell lung cancer (NSCLC). Read More
The long quest for a universal influenza vaccine may soon bear fruit, David Greenberg, associate vice president and regional medical head in North America for Sanofi Pasteur, told BioWorld. "We're moving in the right direction," he said, adding that "it's been tough from a research perspective," though his group – the vaccine division of Paris-based Sanofi SA – has been working internally and with collaborators that include the University of Georgia and others. "Progress is definitely being made toward a vaccine that would provide broader protection. I think it's likely that a candidate vaccine would be going into clinical trials in the next year or two. The testing at least is not a decade away, the way we used to talk about it some years ago." Read More
New data from a phase III study of Pfizer Inc.'s tafamidis in treating the rare and fatal disorder transthyretin amyloid cardiomyopathy (ATTR-CM) showed a 30 percent reduction in the risk of mortality and 32 percent reduction in the rate of cardiovascular-related hospitalizations vs. placebo. The data, presented at the European Society of Cardiology Congress in Munich and simultaneously published online in The New England Journal of Medicine, are likely to lay the groundwork for an upcoming U.S. regulatory filing for the drug. Read More
In findings that underscore the complex roles of inflammation in the brain, researchers have reported that in a transgenic mouse model of Alzheimer's disease (AD), proinflammatory cytokines protected the animals from developing seizures that were severe enough to kill the animals. Read More
Tetraphase Pharmaceuticals Inc. turned the commercial corner with FDA approval of Xerava (eravacycline) to treat complicated intra-abdominal infections, or cIAI. Read More
