By a News Reporter-Staff News Editor at Biotech Week Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, confirmed that Auxilium has received an unsolicited, non-binding proposal from Endo International plc to acquire all of the outstanding shares of Auxilium common stock at a price of $28.10 per share in cash and Endo stock, s
Greifensee, Switzerland October 01, 2014. Weighing applications in pharmaceutical manufacturing can strongly influence the quality of the final product. METTLER TOLEDO experts have created a new white paper, " Regulatory Compliance Weighing in Pharma Manufacturing" that provides a comprehensive overview of weighing-related standards and regulati
By a News Reporter-Staff News Editor at Biotech Week Baxter International Inc. announced that the United States Food and Drug Administration has approved RIXUBIS for routine prophylactic treatment, control and prevention of bleeding episodes, and perioperative management in children with hemophilia B. RIXUBIS was the first recombinant factor IX..
SUMMARY: The Food and Drug Administration is announcing the fee rate for using a rare pediatric disease priority review voucher for fiscal year 2015. The Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Safety and Innovation Act, authorizes FDA to determine and collect rare pediatric disease priority review user
DNA Vaccine pioneer Immunomic Therapeutics, Inc., a privately held biotechnology company, submitted a new Investigational New Drug Application to the FDA on September 10th. ITI plans to use the results from this study, which will take place in Japan, to support future clinical studies in the United States. As a result of submitting IND for the Phas
By a News Reporter-Staff News Editor at Biotech Week Fresh data on Edema are presented in a new report. According to news reporting originating in Shanghai, People's Republic of China, by NewsRx journalists, research stated, "Bevacizumab blocks the effects of vascular endothelial growth factor in leakage-prone capillaries and has been suggested a
By a News Reporter-Staff News Editor at Biotech Week Investigators discuss new findings in Autoimmune Diseases and Disorders. Omalizumab, Food and Drug Administration- approved for asthma, selectively suppresses the activity of IgE, an important immunoglobulin in the pathogenesis of BP. " For more information on this research see: Omalizumab ther
Gilead Sciences reported that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company's Marketing Authorization Application for Harvoni. The CHMP's recommendation will now be reviewed by the European Commission, which has the authority to approve...
Spinal implants are devices that help preserve and restore the functions of the spine by managing spinal disorders. The report covers the Americas, and the APAC and EMEA regions; it also covers the Global Spinal Implants market landscape and its growth prospects in the coming years. The report includes a discussion of the key vendors operating in t
Release date- 30092014- London,- Hikma Pharmaceuticals PLC, the fast growing multinational pharmaceutical group, today announces the approval of its New Drug Application for colchicine 0.6 mg capsules by the US Food and Drug Administration. Hikma will market its colchicine under the brand name MITIGARE. Said Darwazah, Chairman and CEO of Hikma, sai
Innovations announces the upcoming airing of Innovations with Ed Begley, Jr., scheduled to broadcast on Monday, October 20, 2014 at 7:30 a.m. EST/ PT via Discovery Channel. Additionally, audiences will be educated on Ambry Genetics, a College of American Pathologists- accredited and Clinical Laboratory Improvement Amendments- certified commercial c
Release date- 30092014- NEW BRUNSWICK, N.J- Johnson& Johnson today announced a definitive agreement to acquire Alios BioPharma, Inc., a privately held clinical stage biopharmaceutical company focused on developing therapies for viral diseases, for approximately $1.75 billion in cash. 'We are excited that this acquisition will enable us to explore t
By a News Reporter-Staff News Editor at Biotech Week IIR announced the FDA/ CMS Summit for Payers, a new event dedicated to forging collaboration between the key stakeholders in the rapidly evolving healthcare ecosystem. The FDA/ CMS Summit for Payers will bring together leaders from the Food& Drug Administration, Centers for Medicare& Medicaid S
CROIX A lawyer will make a presentation on Friday to federal regulators, describing how Luis Hospital is working to correct deficiencies inspectors turned up in a recent survey, as the hospital tries to avoid being decertified on Oct. 9. Deborah Gardner, a lawyer with Ropes& Gray who has been working on the plan of correction since last week, tol
Navidea Biopharmaceuticals reported that that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending the granting of marketing authorization for Lymphoseek 250 micrograms kit for radiopharmaceutical preparation in the European Union. The CHMP's positive recommendation will...
Sept. 30 LOS ANGELES, Calif A sea change in the way cancer is analyzed and treated has yielded more than one promising treatment for those diagnosed with the breast cancer. Research out of UCLA's Jonsson Comprehensive Cancer Center and Cedars-Sinai Nanomedicine Research Center is showing promise in targeted therapy. In 2012, the Food and Drug A
By a News Reporter-Staff News Editor at Biotech Week NovaBiotics Ltd, the Aberdeen-based clinical-stage biotechnology company, announced that the US Food and Drug Administration has granted orphan drug designation for Lynovex , the Company's first-in-class therapeutic candidate for the treatment of Cystic Fibrosis. Lynovex is being developed
Through the acquisition, OnCore will assume development of Enantigen's two novel discovery programs, one targeting inhibition of s-antigen secretion and one targeting capsid assembly inhibition. "We believe that OnCore is in the best position to rapidly advance our programs into human clinical trials, and we look forward to joining the OnCore rese
By a News Reporter-Staff News Editor at Biotech Week According to news reporting originating from Alexandria, Virginia, by NewsRx journalists, a patent by the inventors Ghidini, Eleonora; Capelli, Anna Maria, filed on March 15, 2012, was published online on September 16, 2014. The assignee for this patent, patent number 8835412, is Chiesi Farmace
According to a company release, FDA approval of ILUVIEN entitles pSivida to a $25 million milestone from its licensee Alimera Sciences. pSivida will also be entitled to 20 percent of the net profits from sales of ILUVIEN in the U.S. "FDA approval of ILUVIEN, our third FDA- approved product for retinal disease, provides an important treatment optio
Qualis Health and its partners have released the Behavioral Health Integration Implementation Guide, a set of tools to help safety net providers integrate behavioral health care and improve patient outcomes and experience. "The integration of behavioral health is particularly important now as safety net providers are challenged to meet the...
ReportsnReports.com offers "Global Operating Room Equipment Market 2014-2018" research report in its store. An operating room is a room with a sterile environment in a healthcare facility used to perform surgical procedures. The report covers the Americas, and the APAC and EMEA regions; it also covers the Global Operating Room Equipment market land
ReportsnReports.com offers "Medical Electrodes Market in Europe 2014-2018" research report in its store. Analysts forecast the Medical Electrodes market in Europe to grow at a CAGR of 8.32 percent over the period 2013-2018.. The report covers the Americas, and the EMEA and APAC regions; it also covers the Medical Electrodes market in Europe landsca
By a News Reporter-Staff News Editor at Biotech Week Salix Pharmaceuticals, Ltd. announced that the Food and Drug Administration considers the Company's August 29, 2014 resubmission of its supplemental New Drug Application for XIFAXAN 550 mg tablets for the proposed indication of the treatment of irritable bowel syndrome with diarrhea or IBS-D
By a News Reporter-Staff News Editor at Biotech Week Salix Pharmaceuticals, Ltd. announced that Cipla Limited has granted Salix exclusive rights under certain patent applications in the "Rifaximin Complexes" patent family controlled by Cipla. Additionally, Salix and Cipla have expanded the scope of their 2009 exclusive license agreement whereby C