Below is a look at some of the headlines for companies that made news in the healthcare sector on June 18, 2013.{ nfg} ACADIA Pharmaceuticals Inc., a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, presented data today from its Phase III progra
By a News Reporter-Staff News Editor at Biotech Week Research and Markets has announced the addition of the "ADHD Therapeutics Market to 2018- New Diagnostic Parameters for Adult ADHD Offer Hope for Higher Rates of Treatment" report to their offering. While high disease prevalence encourages pharmaceutical companies to enter into the ADHD market,
ALS-8176 is a structurally novel, anti-respiratory syncytial virus nucleoside analog that is being developed for the treatment of acute RSV infection. It is the only known nucleoside analog currently in clinical development for the treatment of RSV. ALS-8176 demonstrates potent anti-viral activity across multiple strains of RSV in preclinical studi
On June 19, 2013, Amarin Corporation plc issued a press release titled "Amarin Informed by FDA of October 16th Advisory Committee Date in Connection with Supplemental New Drug Application for Vascepa (R) in the Treatment of Patients with High Triglycerides (> 200 mg/dL and.
BEDMINSTER, N.J. and DUBLIN, Ireland, June 19, 2013 Amarin Corporation plc, a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that it was informed yesterday by the U.S. Food and Drug Administration that the FDA will convene an advisory committee on Octobe
The team at Amplion Research, publishers of BiomarkerBase?, manually reviewed every IVD test cleared or approved by the FDA since 2000, adding to the extensive set of test, drug, and clinical trial data already included in the database. Being aware of all existing clinical applications for molecular biomarkers is an important part of the groun
By a News Reporter-Staff News Editor at Biotech Week ARIAD Pharmaceuticals, Inc. announced long-term durability-of-response data from its Phase 1 trial of Iclusig in heavily pretreated patients with resistant or intolerant chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia. These data are being featured..
By a News Reporter-Staff News Editor at Biotech Week ARIAD Pharmaceuticals, Inc. announced updated clinical results on its investigational tyrosine kinase inhibitor, AP26113, in patients with advanced non-small cell lung cancer from an ongoing Phase 1/ 2 trial. The study confirms compelling clinical evidence of the anti-tumor activity of AP26113
Array BioPharma Inc. said that interim results from an ongoing ARRY-520 clinical trial in multiple myeloma were presented at the 2013 Congress of the European Hematology Association in Stockholm, Sweden. In a release, the Company noted:. Reversible neutropenia is the most common adverse event and does not appear to be additive relative to the obser
By a News Reporter-Staff News Editor at Biotech Week Research and Markets has announced the addition of the "Bosulif- Forecast and Market Analysis to 2022" report to their offering. Bosulif received FDA approval in September 2012 for Ph+ CP, AP, or BP CML that is resistant to other therapies, including Gleevec. In Europe, Bosulif was recommended
June 19 Amarin Corp. plc, the Irish biotech with research-and-development headquarters in Groton, announced today that the U.S. Food and Drug Administration will convene an advisory committee Oct. 16 to consider a supplemental new drug application for heart pill Vascepa. The advisory committee is expected to vote on whether to recommend the appro
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MOUNTAIN VIEW, Calif., June 19, 2013 ChemoCentryx, Inc. announced that it has completed the target enrollment of 270 patients in a Phase II clinical trial in diabetic nephropathy with CCX140, an inhibitor of the chemokine receptor known as CCR2 and the Company's lead wholly owned drug candidate. Enrollment will be closed by June 30, 2013, at whic
McGuff Pharmaceuticals, Inc. continues to pursue the approval of an Abbreviated New Drug Application for Hydroxyprogesterone Caproate Injection, USP 250 mg/mL, 5 mL, multiple dose vial; a generic version of Bristol-Myers Squibb s drug fomerly known as Delalutin?. Regarding the status of our pending ANDA, to date, McGuff has responded to all Fo
Depomed, Inc. is disclosing that as of June 19, 2013 the website of the U.S. Food and Drug Administration indicates that an Abbreviated New Drug Application for a generic version of Zipsor has been submitted. Depomed has not received a Paragraph IV certification with respect to this ANDA filing and does not know the identity of the party that fi
Bharat Book Bureau has recently added DrugPatentWatch to its extensive list of Online Databases. DrugPatentWatch provides comprehensive information on pharmaceutical, drug patents and their expirations. -Patent litigation- Paragraph IV challenges- International patent families, patent priority, and PCT information- Patent maintenance, reexamination
The FDA approved Sientra/Silimed in March 2012 and Allergan 410 in February 2013. Joseph Bauer of the Swan Center for Plastic Surgery was one of the select plastic surgeons involved in the FDA trials, and he is now pleased to offer the newest breast implants to his patients. The Swan Center for Plastic Surgery is a leader in the United States for v
By a News Reporter-Staff News Editor at Biotech Week Genentech, a member of the Roche Group, announced final results from the Phase III AVAglio study in people with newly diagnosed glioblastoma, the most common and aggressive form of primary brain cancer. Avastin is currently approved in the United States under the U.S. Food and Drug Administrati
Glycotope GmbH/ Glycotope Has Completed Randomization of Phase II Clinical Trial with Glycooptimized and Fully Human FSH-GEX (TM) for In Vitro Fertilization. Processed and transmitted by Thomson Reuters ONE. Berlin, Germany, June 19th, 2013- Glycotope GmbH, a global leader in optimizing the glycosylation of biopharmaceuticals, announced today that
GVK Biosciences today announced that it has licensed its popular SAR, PK and Toxicity Database to the US Food and Drug Administration. The Material Transfer Agreement forms the basis of collaboration in Drug Repositioning, wherein the initial focus will be to identify alternative therapeutic indications of marketed compounds for neglected and orpha
MONROVIA, Calif., June 19, 2013 Immunotech Laboratories, Inc. today announced the results from Gap Analysis report. This report is the first step in the moving towards FDA clinical trials for Immunotech Laboratories. Zhabilov and Mr. Nabors stated that Immunotech Laboratories is now preparing for the Pre-IND studies that will begin by the end of
In addition to participating in 10 educational sessions, INC Research executives will be on- hand at Booth #81 to discuss the Company's efforts to deliver greater efficiency and predictability in drug development by leveraging leading technology and processes. "Biopharmaceutical companies today are looking for increased transparency, trust and...
Incyte Corp. announced results from two ongoing clinical trials of Jakafi, an oral JAK1 and JAK2 inhibitor that is FDA- approved for the treatment of patients with intermediate or high- risk myelofibrosis, that were presented at the 18th Congress of the European Hematology Association in Stockholm, Sweden. "Results of these studies represent the c
Incyte Corp. announced results from two ongoing clinical trials of Jakafi, an oral JAK1 and JAK2 inhibitor that is FDA- approved for the treatment of patients with intermediate or high- risk myelofibrosis, that were presented at the 18th Congress of the European Hematology Association in Stockholm, Sweden. "Results of these studies represent the c
By a News Reporter-Staff News Editor at Biotech Week Infinity Pharmaceuticals, Inc. will be presenting at the Goldman Sachs 34th Annual Global Healthcare Conference on June 12, 2013, at 10:40 a.m. PT in Palos Verdes, CA. About Infinity Pharmaceuticals, Inc. Infinity is an innovative biopharmaceutical company dedicated to discovering, developing a
