Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products. SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled "Guidance on Meetings With Industry and...
RICHMOND, Va., May 23, 2013 AIBioTech is pleased to announce receipt of a firm fixed price subcontract from DynPort Vaccine Company LLC, a CSC company, valued at nearly $3 million for laboratory studies to support development of a biologic intended for use prior to an exposure to nerve agents. DVC issued this subcontract under its prime contract
The following should be read in conjunction with our consolidated financial statements and related notes beginning on page F-1 of this Annual Report. On September 16, 2011, the business of Alkermes, Inc. and EDT were combined under the Business Combination in a transaction accounted for as a reverse acquisition with Alkermes, Inc. treated as the ac
Release date- 22052013- Alliance Pharma plc, the speciality pharmaceutical company, will hold its Annual General Meeting in London later this morning. Michael Gatenby, the Company's Chairman, will make the following comments:. There have been reduced sales of Nu-SealsTM in Ireland although measures to counteract generic competition are helping to m
Antares Pharma, Inc. today announced the election of Marvin Samson to the Company s Board of Directors. Leonard S. Jacob, M.D., Ph.D., Chairman of the Board of Antares Pharma, stated, I have been an industry colleague of Marvin Samson for many years. I have observed the rapid growth of Antares Pharma over the past few years, and I am excit
CHERTSEY, England, May 23, 2013/ PRNewswire/. ASTELLAS PHARMA EUROPE B.V., the European subsidiary of Tokyo- based Astellas Pharma Inc., today announced the Dutch Medicines Evaluation Board has granted marketing authorisation for VESOMNI in the Netherlands. The Netherlands will be the Reference Member State for further registration of VESOMNI thr
Biogen Idec announced that it has submitted a Biologics License Application to the U.S. Food and Drug Administration for approval of PLEGRIDY, the company's pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis. "This filing demonstrates our dedication to the treatment of MS, both through the discovery of new medica
BioSyent Inc. is pleased to announce that its subsidiary, BioSyent Pharma Inc., has submitted two new drug products to Health Canada seeking marketing approval. These products will provide hospitals, clinics, and healthcare professionals with improved patient safety as well as operational efficiencies and will complement BioSyent's Hospital Divisio
Release date- 22052013- Ingelheim, Boehringer Ingelheim announced today that the U.S. Food and Drug Administration has issued a warning letter concerning its manufacturing practices following an agency inspection in Ingelheim, Germany in November 2012. 'Boehringer Ingelheim is taking this issue very seriously and is fully committed to working with
Ranbaxy products such as generic Lipitor have been on Oregon pharmacy shelves, and pharmacy board members are concerned over whether enough has been done to protect consumers, said the pharmacy board's executive director, Gary Schnabel. State regulators learned of the case from a Fortune Magazine article, not from the Food and Drug Administration,
Celerion has announced the appointment of Dr. Bruce Morimoto as Executive Director of Applied Translational Medicine. Prior to joining Celerion, he was Vice President of Drug Development at Allon Therapeutics, where his focus was to manage their neurodegeneration and dementia therapeutic programs including preclinical, manufacturing and clinical...
Celgene International Srl, a subsidiary of Celgene Corporation today announced that the U.S. Food and Drug Administration has assigned a Priority Review designation to the supplemental New Drug Application for the use of ABRAXANE^ in combination with gemcitabine for the first line treatment of patients with advanced pancreatic cancer.
BOUDRY, Switzerland Celgene International Srl, a subsidiary of Celgene Corporation today announced that the U.S. Food and Drug Administration has assigned a Priority Review designation to the supplemental New Drug Application for the use of ABRAXANE in combination with gemcitabine for the first line treatment of patients with advanced p
LAUSANNE, Switzerland and DRESDEN, Germany, May 23, 2013/ PRNewswire/. "We are very excited to launch this new relationship with Debiopharm, extending their repertoire with what we consider to be some of the most strategically powerful cell-based screening paradigms developed to date," said Dr. Christophe Echeverri, CEO/CSO of Cenix BioScience.
Office Address: Department of Health and Human Services; Food and Drug Administration; Office of Acquisitions and Grants Services; 5630 Fishers Lane, Room 2129 Rockville MD 20857-0001. Description: Department of Health and Human Services. Office of Acquisitions and Grants Services.
Location: Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services. Classification Code: D- Information technology services, including telecommunications services. Subject: Access to Data& Analytics on Expenditures/Activity by Pharmaceutical Companies on Prescription Drug Promotion.
Covidien, a global provider of healthcare, announced that its Nellcor pulse oximetry portfolio, which is used to measure arterial oxygen saturation, has received U.S. Food and Drug Administration 510 clearance for motion claims. According to a release, this makes Covidien the first company to receive FDA clearance for a motion-tolerant bedside puls
CytRx Corp., a biopharmaceutical research and development company specializing in oncology, has announced initial data from a Phase 1 b clinical trial evaluating the pharmacokinetics and safety of aldoxorubicin, its novel conjugate of the widely used chemotherapeutic agent doxorubicin, in patients with metastatic solid tumors who have either relaps
Dealing the reputation of Indian promoters a big blow, Japanese pharmaceuticals major Daiichi Sankyo on Wednesday indicated it may initiate legal steps against the former promoters of India's biggest drug maker Ranbaxy Laboratories- Malvinder Mohan Singh and family- saying the former shareholders of the company "concealed and misrepresented critica
- An employee of Novartis Pharma K.K. is found to have participated in clinical research using a major blood pressure treatment without identifying employment status in research papers, with some papers having been retracted due to problems with data. Norvatis Pharma, a Japanese unit of Swiss drug company Novartis AG, said that "nothing has been fo
The Board of Elan will, as before, in line with its obligations under Irish Takeover law, assess the Royalty Pharma announcement and will advise its shareholders accordingly. In the meantime, Elan shareholders are strongly advised to take no action in relation to the Royalty Pharma offer. Any holder of 1 percent or more of any class of relevant sec
WASHINGTON The Food and Drug Administration said Thursday it approved a new blood test from Roche to help doctors diagnose diabetes. The FDA said Roche's test is the first to be approved to diagnose the disease. "Providing health care professionals with another tool to identify undiagnosed cases of diabetes should help them provide patients appr
THE WOODLANDS, Texas, May 22, 2013 Repros Therapeutics Inc. today announced it has met with the FDA regarding the clinical development of Proellex-V, the vaginally administered product, in the treatment of uterine fibroids. The FDA recommended that a Phase 2 b study should be conducted as a prelude to the Phase 3 program. During the meeting, R
Repros Therapeutics today announced it has met with the FDA regarding the clinical development of Proellex-V, the vaginally administered product, in the treatment of uterine fibroids. The FDA recommended that a Phase 2 b study should be conducted as a prelude to the Phase 3 program. During the meeting, Repros and the FDA agreed that:.
The U.S. Food and Drug Administration approved 12 new molecular entities in the first quarter of 2013. Fitch expects cancer drugs to lead specialty drug authorizations again in 2013, but new diabetes treatments could be a close second. Fitch notes that the FDA has instituted a new program- breakthrough therapy designation- to expedite the drug appr