Horizon Pharma Inc., of Deerfield, Ill., said it expanded its sales force from 80 to 150 representatives to facilitate increased reach and frequency of calls on physicians for its lead product, Duexis (ibuprofen and famotidine), which is indicated for the relief of symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers

The Phase IIb is designed to identify the patient population, defined by biomarker or other disease characteristic, for advancement into the Phase III portion of the trial...Biomarker findings and other patient selection and treatment experience from the Phase IIb stage will be incorporated into the design of Phase III, which the company plans to discuss with the FDA before launching the study this year, Farmer said...The two have nothing to do with each other

A.P. Pharma Inc., of Redwood City, Calif., said it resubmitted its new drug application to the FDA for its lead product candidate, APF530, for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting...AVEO Oncology Inc., of Cambridge, Mass., and Astellas Pharma Inc., of Tokyo, said AVEO submitted a new drug application (NDA) seeking approval of tivozanib, a drug designed to target vascular endothelial growth factor, in patients with advanced renal cell carcinoma

subsidiary of Tokyo-based Astellas Pharma Inc., has submitted a new drug application (NDA) to the FDA seeking approval for tacrolimus extended-release capsules for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients...It was not possible to determine if the heart failure was directly a result of Mirapex or other factors

In other news, 3SBio said its special committee of independent directors has retained Cleary Gottlieb Steen & Hamilton LLP, of New York, as the committee's legal counsel...Astellas Pharma Inc., of Tokyo, and Medivation Inc., of San Francisco, said Xtandi (enzalutamide) capsules are available for patients with metastatic castration-resistant prostate cancer who have previously received docetaxel...In other news, Boehringer said it started an open-label U.S

rights to FDA-approved product Gelclair for treating oral mucositis from the Helsinn Group, of Lugano, Switzerland...Medivation Inc., of San Francisco, and Astellas Pharma Inc., of Tokyo, said Xtandi (enzalutamide) capsules are available for patients with metastatic castration-resistant prostate cancer who have previously received docetaxel

Abbott, of Abbott Park, Ill., said it signed a deal with Tokyo-based Astellas Pharma Inc...to collaborate on a Phase III trial testing ASP0113 (TransVax), an investigational vaccine licensed from Vical Inc., of San Diego, for preventing cytomegalovirus (CMV) reactivations in transplant patients

Armgo Pharma Inc., of Tarrytown, N.Y., said a study published in Cell revealed the underlying role of calcium leak through the ryanodine receptor calcium-release channel on stress-induced cognitive dysfunction – the focus of the company's small-molecule drugs known as Rycals...Piper Jaffray analyst Edward A. Tenthoff said in a research note that the news is "a likely positive" and he continues to expect Cabo approval by the PDUFA date

Renaissance Pharma Inc., of Newtown, Pa., acquired the U.S...and New American Therapeutics Inc., of Cranford, N.J. Renaissance established a new subsidiary, Prestium Pharma, to commercialize the prescription antiviral indicated for the treatment of recurrent cold sores in adults and children 12 years and older

MEI Pharma Inc., of San Diego, will acquire Singapore-based S*BIO Pte Ltd.'s exclusive worldwide rights to pracinostat, an oral histone deacetylase inhibitor of interest for hematologic diseases and solid tumors...Sun Pharmaceutical Industries Ltd., of Mumbai, India, will acquire Taro Pharmaceutical Industries Ltd., of Hawthorne, N.Y., for $39.50 in cash per share paid to shareholders other than Sun Pharma and its affiliates, which currently own about 66 percent of outstanding ordinary shares and

MEI Pharma Inc., of San Diego, will acquire Singapore-based S*BIO Pte Ltd.'s exclusive worldwide rights to pracinostat, an oral histone deacetylase inhibitor of interest for hematologic diseases and solid tumors

Astellas Pharma Inc., of Tokyo, disclosed plans to close subsidiary Urogenix Inc., of Durham, N.C., a research facility focused on urology drug discovery that was acquired in 2006 from Dynogen Pharmaceuticals Inc...In other news, GSK said it submitted applications in the European Union and the U.S

Astellas Pharma Inc., of Tokyo, disclosed plans to close subsidiary Urogenix Inc., of Durham, N.C., a research facility focused on urology drug discovery that was acquired in 2006 from Dynogen Pharmaceuticals Inc

rights to Levadex as well as rights to promote to U.S.-based primary care physicians. (See BioWorld Today, Feb. 1, 2011.) MAP plans to bring in other partners to exploit those additional segments inside and outside the U.S., according to Nelson...Horizon Pharma Inc., of Deerfield, Ill., filed an S3 shelf registration with the SEC for a public offering not to exceed $175 million

The FDA approved Rayos (prednisone) delayed-release tablets by Horizon Pharma Inc., of Deerfield, Ill., for rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma and chronic obstructive pulmonary disease...Myriad Genetics Inc., of Salt Lake City, said it signed a deal with Pharma Mar, of Madrid, Spain, a unit of Grupo Zeltia, under which Myriad will conduct BRCA1 and BRCA2 testing on patients to be enrolled in a Phase II study of PM1183, a drug candidate

Isotechnika Pharma Inc., of Edmonton, Alberta, received funding from the National Research Council Industrial Research Assistance Program for research into the use of non-immunosuppressive cyclosporin analogue molecules for ischemia-reperfusion injury...OPKO plans to commercialize a serum test based on four of the markers that provided a diagnostic sensitivity of 90 percent and a diagnostic specificity of 100 percent to distinguish NMO patients from those with multiple sclerosis or other disorders

The company has partnered with Mitsubishi Tanabe Pharma Corp., of Osaka, Japan, and recently expanded this collaboration to develop a second protein therapeutic for an undisclosed orphan disease using Synageva's development capabilities and protein expression platform. (See BioWorld Today, April 3, 2012.) While the capital market has been conducive for companies with market caps north of $500 million, the picture has not been as bright for small biotechs...These include those for Vivus, Horizon

Astellas Pharma Inc., of Tokyo, said it submitted a European marketing authorization application for enzalutamide (MDV3100) for treatment of men with metastatic castration-resistant prostate cancer who previously have been treated with docetaxel-based chemotherapy...In other news, Astellas said the FDA approved Myrbetriq (mirabegron) to treat adults with overactive bladder

Astellas Pharma Inc., of Tokyo, said the FDA approved Myrbetriq (mirabegron) to treat adults with overactive bladder