The biotech will evaluate the peptides to treat beta thalassemia and other diseases associated with iron overload...Optimer Pharmaceuticals Inc., of San Diego, and Astellas Pharma Europe Ltd., a subsidiary of Tokyo-based Astellas Pharma Inc., said the European Commission granted marketing authorization for Dificlir (fidaxomicin) tablets for the treatment of adults with Clostridium difficile infections (CDI), also known as Clostridium difficile-associated diarrhea

Inhibitex plans to add patients in two additional arms in the 12-week trial to include 100-mg and 200-mg doses, Deutsche Bank analyst Robyn Karnauskas said in a research note, calling that "a good strategic use of funds" since both of those regimens should be studied "in as robust a way as possible...But, if data for INX-189 continue to flow positive, the company could find itself in an enviable position for a lucrative big pharma partnership or even an acquisition, as biopharma races to create the

Idera Pharmaceuticals Inc., of Cambridge, Mass., reported preclinical data demonstrating that its gene-silencing oligonucleotides (GSOs) exert target-specific gene-silencing activity following systemic delivery, while minimizing the sequence-dependent immune stimulation that is associated with other approaches to gene silencing...Profectus BioScience Inc., of Baltimore, said it received a commitment of additional funding from the PATH Malaria Vaccine Initiative to support proof-of-concept studies

And Swiss pharma Roche had its plans to enter the diabetes space derailed after safety issues cropped up in late-stage studies of taspoglutide, a GLP-1 drug partnered with Ipsen SA. (See BioWorld Today, Sept. 14, 2010.) Amylin had been working with Lilly on exenatide since 2002, first creating twice-daily GLP-1 drug Byetta, which managed to pull in 2010 sales of $710 million despite increasing competition in the diabetes space, particularly with the January 2010 approval of Victoza (liraglutide

And Swiss pharma Roche had its plans to enter the diabetes space derailed after safety issues cropped up in late-stage studies of taspoglutide, a GLP-1 drug partnered with Ipsen SA. (See BioWorld Today, Sept. 14, 2010.) Amylin had been working with Lilly on exenatide since 2002, first creating twice-daily GLP-1 drug Byetta, which managed to pull in 2010 sales of $710 million despite increasing competition in the diabetes space, particularly with the January 2010 approval of Victoza (liraglutide

Asahi Kasei Pharma Corp. (AKP), of Tokyo, and Zosano Pharma Inc., of Fremont, Calif., entered a long-term collaboration to develop, commercialize and supply a weekly transdermal patch formulation of Teribone (teriparatide acetate), AKP's formulation of human parathyroid hormone for the treatment of osteoporosis patients with a high risk of fracture...In other news, Boehringer granted Gilead Sciences Inc., of Foster City, Calif., exclusive worldwide rights for the research, development and

Through the research, the companies will seek to identify progression and other biomarkers that could segregate healthy elderly controls, patients with mild cognitive impairment and patients with Alzheimer's...rights to an undisclosed company to market modafinil tablets, the generic version of Provigil...Zosano Pharma Inc., of Fremont, Calif., and Asahi Kasei Pharma Corp. (AKP), of Tokyo, entered a long-term collaboration to develop, commercialize and supply a weekly transdermal patch formulation of

Somaxon Pharmaceuticals Inc., of San Diego, said the FDA provided clinical and regulatory guidance to move an OTC version of Silenor forward, including the development of an OTC label tailored to Silenor's clinical profile and differentiated from other OTC sleep products that could potentially enable Silenor to become the first prescription insomnia agent converted to an OTC product

In return, Inspiration will issue a convertible note to Ipsen, bringing Ipsen's fully diluted equity ownership position in Inspiration to approximately 38 percent...Mitsubishi Tanabe Pharma Corp., of Osaka, Japan, received approval for the manufacturing and marketing of Telavic (telaprevir) in Japan to treat chronic hepatitis C. Mitsubishi licensed Japanese and Chinese rights to the drug from Cambridge, Mass.-based Vertex Pharmaceutical Inc., which markets it in the U.S

Action Pharma A/S, of Aarhus, Denmark, released top-line results for its Phase IIb AP214 trial in patients undergoing major cardiac surgery, indicating that AP214 is safe, reduces kidney injury and improves 90-day outcomes on a composite end point (death, dialysis and kidney function) in patients undergoing cardiac surgery with cardiopulmonary bypass who are at increased risk of developing acute kidney injury...Amarin plans to separately seek approval for the treatment of high triglycerides in

Trying to block an all-stock merger of AMAG Pharmaceuticals Inc...Failure to comply may result in delisting of the company's securities...In separate news, the CHMP also recommended approval of Edurant as a once-daily treatment in combination with other HIV-1 medications

In separate news, Aestus said it expanded its research collaboration with the ALS Therapy Development Institute to test additional small-molecule compounds for the ability to slow or stop the progression of amyotrophic lateral sclerosis...The article contrasted the ability of AE37 to stimulate CD4+ helper T cells with other therapeutic peptide vaccines that primarily stimulate CD8+ T cells

Destiny Pharma Ltd., of Brighton, UK, said lead candidate XF-73 was selected for Phase I evaluation by the National Institute of Allergy and Infectious Diseases...Lpath Inc., of San Diego, said the National Institutes of Health's Type I Diabetes Preclinical Testing Program will provide financial support for the further study of Lpathomab's efficacy in animal models of the disease, particularly diabetic neuropathy

Labopharm Inc., of Laval, Quebec, and Gruppo Angelini SpA, of Rome, agreed to restructure their joint venture partnership for Oleptro, terminating existing agreements, with Labopharm granting Angelini an exclusive license and rights to the depression drug in the U.S., Canada and other countries in exchange for a royalty on product sales...Sorrento Therapeutics Inc., of San Diego, received a Phase I Small Business Technology Transfer Research grant from the National Institute of Allergy and

Marshall Edwards Inc., of San Diego, reported results of a preclinical study that showed NV-128 can target the mitochondria in patient-derived ovarian cancer stem cells to induce cell death in an otherwise chemo-resistant cell population...Trius Therapeutics Inc., of San Diego, will collaborate with Bayer Pharma AG, of Leverkusen, Germany, to develop and commercialize Trius' lead Phase III antibiotic, torezolid phosphate, in Africa, Asia (excluding North and South Korea), Latin America and the

Ltd., of Osaka, Japan, entered an agreement to acquire all currently marketed products from Victory Pharma Inc., of San Diego, including seven treatments for pain and two for infectious diseases

to develop and commercialize the drug in Europe and certain other countries. (See BioWorld Today, June 1, 2011...Ltd., of Osaka, Japan, entered an agreement to acquire all currently marketed products from Victory Pharma Inc., of San Diego, including seven treatments for pain and two for infectious diseases

The biotech has five clinical-stage candidates, including BL-1040, a heart attack treatment that has completed a Phase I/II study and has been out-licensed to Ikaria Inc., of Hampton, N.J. In other news, BioLineRx enrolled the first subject in a Phase I study of BL-1021, an oral small molecule aimed at treating neuropathic pain...All other shareholders in Sophion also agreed to sell their ownership shares...TcL Pharma SAS, of Nantes, France, changed its name to Effimune SAS

Multicell Technologies Inc., of San Diego, is sponsoring research at the University Health Network Toronto General Hospital to evaluate its candidates MCT-465 and MCT-485 for primary liver cancer...TcL Pharma SAS, of Nantes, France, changed its name to Effimune SAS