Regeneron Pharmaceuticals Inc. sold an FDA advisory committee on the benefits of its Eylea as an every-other-month treatment for the neovascular form of age-related macular degeneration (wet AMD). Read More
WASHINGTON – The battle lines have been drawn over how big of an increase the FDA needs in fiscal 2012. House Republicans have said 11 percent should do it, but the president wants a lot more. Read More
The most typical sort of stem cell research involves trying to get them to divide and differentiate according to plan, making whatever cell type it is that a researcher is looking for. Read More
Celgene Corp.'s Istodax (romidepsin) got an accelerated nod, as expected, in peripheral T-cell lymphoma (PTCL) patients who have received at least one prior therapy, pitting it against Allos Therapeutics Inc.'s Folotyn (pralatrexate), a drug that suffered slower-than-expected sales despite being the first approved for PTCL. Read More
Cleveland BioLabs Inc., of Buffalo, N.Y., raised $23.5 million through a registered direct offering of 5.87 million shares and 2.94 million warrants. The firm sold the units at $4 apiece – a 10 percent discount to the closing price of $4.45 on Thursday – with each unit consisting of one share of common stock and two warrants to purchase one-quarter of an additional share. Read More
Sunshine Biopharma Inc., of Montreal, signed an agreement with the Jewish General Hospital to advance lead compound Adva-27a through preclinical development and Phase I trials. Adva-27a is a small-molecule Topoisomerase II inhibitor. Sunshine also has a similar agreement with the Research Foundation of the State University of New York, acting on behalf of Binghamton University, of Binghamton, N.Y. Read More
Titan Pharmaceuticals Inc., of South San Francisco, received a letter from the FDA providing comments on the revised statistical analysis plan (SAP) for a confirmatory Phase III study of Probuphine in patients with opioid dependence. Although the data review at all clinical sites is complete and the blinded dataset ready for analysis, Titan said it will need to delay the analysis briefly to allow time for a discussion with the FDA and subsequent modification of the SAP as necessary. Read More
Older adults have a below-average outlook that their immune system will accept an organ transplant – and apparently part of the reason is that their sex hormones keep their thymus in check. Read More
