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
Actavis, Inc. and Kissei Pharmaceutical Co., LTD today confirmed that they have filed lawsuits against Sandoz Inc., Hetero USA, Inc., Hetero Labs Limited and Hetero Labs Limited, Unit III in the U.S. District Court for the District of Delaware for infringement of U.S. Actavis and Kissei's lawsuits were filed in response to Abbreviated New Drug Appl
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
Continuing its long history of proven clinical performance in diagnosis of myocardial infarction, Beckman Coulter, Inc. announces the U.S. Food and Drug Administration 510 clearance of its new Access AccuTnI +3 troponin I assay for use on its Access 2 immunoassay system. "Clinicians have depended on Beckman Coulter's troponin I test for over 12 ye
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
The U.S. Department of Health and Human Services published the following notice in the Federal Register from the Food and Drug Administration:. A Notice by the Food and Drug Administration on 06/19/2013. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration. Location: FDA White Oak Campus, Building 31, the Great Room, White Oak Conference Center, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. Information regarding special accommodations due to a disability, visitor parking, and trans
Cempra, Inc., a clinical-stage pharmaceutical company focused on developing differentiated antibiotics to meet critical medical needs in the treatment of bacterial infections, today announced that it has completed its previously announced underwritten public offering of 7,250,000 shares of common stock, plus an additional 1,023,938 shares issued...
Cempra, Inc., a clinical-stage pharmaceutical company focusing on developing differentiated antibiotics, announced that it has priced an underwritten public offering of 7,250,000 shares of its common stock at a price of $7.00 per share for aggregate gross proceeds of $50.8 million. Barclays, Stifel and Cowen and Company are acting as joint book- ru
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
The Corporate Whistle Blower Center is urging pharmaceutical industry insiders or medical doctors to call them about possibly huge rewards, if they possess proof of off labeling medication schemes, drug price fixing, or medical doctor kick backs arrangements, that have been designed to cheat the US taxpayers, and Medicare. If you work for a large d
CryoLife, Inc., a leading tissue processing and medical device Company focused on cardiac and vascular surgery, announced today that it has received conditional approval of its Investigational Device Exemption for PerClot from the United States Food and Drug Administration. PerClot has CE Mark designation and CryoLife began distributing PerClot in.
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
In a statement, the commission said the companies, including Ranbaxy Laboratories, Arrow Group and Zoetis Products, formed a "club" and that there was "a pile of$$$ to be shared among the participants." The issue is also making news in the United States, where the Supreme Court recently recently ruled drug companies could be sued by federal regulat
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
By a News Reporter-Staff News Editor at Biotech Week Easton Pharmaceuticals, Inc., a specialty pharmaceutical company that designs, develops, and markets a premium array of topically-delivered therapeutic healthcare products, announced its initiatives to enter into the Medical Marijuana Sector in both the U.S. and Canadian Markets.
By a News Reporter-Staff News Editor at Biotech Week EGEN, Inc., a clinical stage biopharmaceutical company, announced that EGEN's proprietary lung targeting Staramine-mPEG nanoparticle delivery system has been used to administer an inhibitor of microRNA-145 in a rat model of severe occlusive PAH. William Gerthoffer at the University of South Ala
NORTHVALE, N.J., June 19, 2013 Elite Pharmaceuticals, Inc., a specialty pharmaceutical company dedicated to developing and commercializing oral sustained and controlled release product formulations and generics with high barriers to entry, announced today the Company will host a conference call on Monday, June 24, 2013 at 11:00 AM EDT to review t
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
FDA -2013- N-0683, FDA -2013- N-0684, and FDA -2013- N-0685 ". SUMMARY: The Food and Drug Administration is announcing a public meeting regarding FDA's implementation of Title VII of the Food and Drug Administration Safety and Innovation Act, which provides FDA with important new authorities to help it better protect the integrity of the drug suppl
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
