FDAnews Drug Daily Bulletin

Schering AG and Novartis have pushed back the development timetable for one of their most important pipeline candidates -- experimental colon-cancer drug PTK/ZK -- after it failed to stop the growth of tumors in a Phase III study, the companies said.

Tremendous advances in the biopharmaceutical sciences, including in the field of genomics, have given pharmaceutical firms vast amounts of new information on which to develop drugs -- a key development that will fundamentally change the way drugmakers operate, industry experts say.

Before safety concerns over Cox-2 inhibitors and antidepressant use in children made front-page headlines, the pharmaceutical industry had to deal with revelations that widely used hormone replacement therapies (HRTs) posed significant health risks -- a finding that is now being questioned by an industry analyst.

The FDA has issued a warning letter to Canadian drugmaker Germiphene after an inspection of the company's Brantford, Ontario, plant revealed significant deviations from current good manufacturing practices (cGMPs).

Dainippon Pharmaceutical and Zoegene jointly announced on March 23 that they have entered into a joint research agreement in the fields of diabetes and obesity.

Cleveland BioLabs (CBL), a Cleveland Clinic spin-off developing new therapies to reduce the negative effects of cancer treatment and enhance the ability of people to withstand radiation exposure, has received a $5.9 million investment from a group of institutional and private investors led by Sunrise Equity Partners, L.P. of New York.

An assistant professor at the state University at Albany's Gen*NY*Sis Center for Excellence in Cancer Genomics has been awarded a $1.43 million research grant from the National Institutes of Health.

The 10 drug companies behind a recently established discount card for the uninsured are launching an advertising campaign to promote it.

Israeli start-up Rosetta Genomics completed a $4 million financing round in the past few days, its third, from private investors. Kadima High Tech, controlled by Yossi Ben-Yosef, led the round.

Fujisawa Pharmaceutical announced on March 23 that the company has agreed with API Corporation on the bulk production of Cefzon, Fujisawa's proprietary oral cepharosporin antibiotic.

BioTech Medics has closed on the $1.25 million acquisition of five FHJ Scientific Inc.'s five U.S. letters of patent and related foreign patents covering a novel compound solution.

Home Solutions Health, a market leader in providing a cost effective relief from the discomfort of hemorrhoids via its patented and FDA approved HemorRelief product, is announcing its intent to overhaul all of its core marketing materials to better position the company in the overwhelming demanding marketplace.