SHENYANG, China and VILLA GUARDIA, Italy, Jan. 25, 2015/ PRNewswire/ 3 SBio Inc., "3 SBio", a leading China- based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced that on December 31, 2014, 3 SBio acquired the entire share capital of Sirton Pharmaceuticals SpA from
Actinium Pharmaceuticals, Inc., a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that it has submitted a request for a pre-IND meeting to the U.S. Food and Drug Administration for the company's Iomab-B drug candidate currently undergoing final preparations..
SUMMARY: In accordance with the Paperwork Reduction Act of 1995, the Railroad Retirement Board is forwarding an Information Collection Request to the Office of Information and Regulatory Affairs, Office of Management and Budget. Our ICRdescribes the information we seek to collect from the public. Review and approval by OIRA ensures that we impose..
ALK's partner for Japan, Torii Pharmaceutical Co. Ltd., has submitted a registration application- a New Drug Application- to the Japanese Ministry of Health, Labour and Welfare, for ALK's house dust mite sublingual allergy immunotherapy tablet. Jens Bager, ALK's President and CEO, said: " This regulatory submission in Japan represents a major step
PETAH TIKVA- Antares Pharma Inc. announced that the U.S. Food and Drug Administration or FDA has issued a complete response letter regarding the Abbreviated New Drug Application or ANDA for Sumatriptan Injection USP for the acute treatment of migraine. The complete response letter from the FDA provided revisions to labelling and cited minor deficie
Antares Pharma, Inc. today announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the Abbreviated New Drug Application for Sumatriptan Injection USP for the acute treatment of migraine. As previously disclosed, Teva Pharmaceutical Industries, Ltd. would distribute the product and share the profits equal
By a News Reporter-Staff News Editor at Pharma Business Week Axion Power International, Inc., a developer of advanced lead-carbon PbC batteries, energy storage systems and frequency regulation systems, announced that Donald F. Farley, 72, has been appointed to its Board of Directors, effective January 10, 2015. As president of Farley& Associat
"We are enthusiastic to have the opportunity to work with Dr. Lewis in his new capacity as Chairman of the Board. Given the recent filing of an IND with the FDA to initiate a dose escalating Phase I/II clinical trial in lung cancer, we believe that having a Chairman with the industry experience of Dr. Lewis will strategically position Batu Biologic
By a News Reporter-Staff News Editor at Biotech Business Week Biogen Idec announced that it has agreed to acquire U.K.- based Convergence Pharmaceuticals, a clinical-stage biopharmaceutical company with an innovative portfolio of ion channel-modulating product candidates for neuropathic pain. Biogen Idec plans to leverage Convergence's expertise
By a News Reporter-Staff News Editor at Biotech Business Week Before joining Caligor, Ms. Frascello served as Director of Global Business Development at Idis Inc., where she guided pharma and biotech companies through the strategic planning process for developing global patient access and compassionate use programs. Ms. Frascello had oversight fo
Cellceutix Corporation, a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology and antimicrobial applications, is pleased to announce that it is submitting a request early this week to the Food and Drug Administration Division of Gastroenterology and Inborn Errors Products to conduct a...
Centene Corporation announced today that it has signed a definitive agreement to acquire Agate Resources, Inc., a diversified holding company that offers an array of healthcare products and services to Oregon residents. Trillium Community Health Plan, Inc., a subsidiary of Agate, participates in Oregon's Coordinated Care Organization model to pro
An Allegheny Health Network clinical trial examining whether intranasal corticosteroids stunt children's growth the first such trial conducted in accordance with U.S. Food and Drug Administration guidelines- found a small but statistically significant growth reduction for children taking the medication to treat allergic rhinitis, or hay fever.
By a News Reporter-Staff News Editor at Managed Care Weekly Digest- A new analysis by researchers at Brigham and Women's Hospital and the CVS Health Research Institute, published on-line first in the American Journal of Public Health, shows that enhanced prescription drug insurance can improve patient health outcomes and reduce use of other, ofte
By a News Reporter-Staff News Editor at Gastroenterology Week Current study results on Liver Diseases and Conditions have been published. According to news reporting originating from Gifu, Japan, by NewsRx correspondents, research stated, "Sarcopenia is characterized by the loss of skeletal muscle mass, and is reported to appear in patients with
"For 15 years clinical quality has always been the first order of business at DaVita," said DaVita HealthCare Partners Co-Chairman and CEO Kent Thiry. CMS Quality Incentive Program According to the QIP results, released by CMS in mid-January, DaVita ranked first in three of four clinical measures in the ESRD program. This is the second straight yea
By a News Reporter-Staff News Editor at Clinical Trials Week The EORTC is proud to announce the signing of an agreement with the US National Cancer Institute, and the European Medicines Agency to produce a first of its kind meeting to collaboratively explore current issues in cancer drug development. Denis Lacombe, EORTC Director and Co-Chair of
By a News Reporter-Staff News Editor at Clinical Trials Week EnteroMedics Inc. announced that the U.S. Food and Drug Administration has approved VBLOC vagal blocking therapy, delivered via the Maestro System, for the treatment of adult patients with obesity who have a Body Mass Index of at least 40 to 45 kg/m2, or a BMI of at least 35 to 39
By a News Reporter-Staff News Editor at Clinical Trials Week Regulatory News: ERYTECH Pharma, the French biopharmaceutical company that develops innovative' tumor starvation' treatments for acute leukemia and other oncology indications with unmet medical needs, announces its financial calendar for 2015. February 10, 2015:. Publication of full yea
PARIS- The European markets are poised for a lower open on Monday, as the victory of the anti-austerity Syriza party in Greece raised concerns about the country's continuity in the eurozone. On the corporate front, Sanofi and Regeneron Pharmaceuticals, Inc. said the US Food and Drug Administration has accepted for priority review the Biologics Lice
Release date- 23012015- The U.S. Food and Drug Administration today approved Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. Bexsero is the second vaccine approved by the FDA in the past three months to prevent this disease. 'With today's approval o
By a News Reporter-Staff News Editor at Pharma Business Week Clinical research company Antria, Inc. announced that the United States Food and Drug Administration has approved the next step in medical research to help patients look younger using their own stem cells. Antria is the first company to gain FDA approval to initiate Phase 2 clinical tri
BioCryst Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration has granted Fast Track designation for BCX4161, a novel, orally administered, selective inhibitor of plasma kallikrein in advanced clinical development for the treatment of hereditary angioedema. The Fast Track designation process of the FDA is designed to.
ENP Newswire- 25 January 2015. Release date- 23012015- The U.S. Food and Drug Administration today allowed marketing of the first set of mobile medical apps that allow people with diabetes to automatically and securely share data from a continuous glucose monitor with other people in real-time using an Apple mobile device such as an iPhone.
Notably, the U.S. Food and Drug Administration has not yet approved any submitted generic versions, even though market exclusivity under the original appeals court ruling expired in May 2014. In the meantime, Teva can keep working to convert patients to its less frequently administered 40 mg formulation. Teva exceeded initial expectations in 2014 a