Pharmaceuticals News and Research

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Gilead resubmits NDA for single-tablet regimen of Truvada/TMC278

Gilead Sciences, Inc. announced today that it has refiled a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the single-tablet regimen of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults.

10 Feb 2011

Zogenix completes enrollment in ZX002 Phase 3 study in opioid-experienced adults with moderate to severe pain

Zogenix, Inc. announced today the completion of enrollment in its pivotal Phase 3 efficacy study (Study 801) of ZX002. ZX002 is a novel, oral, single-entity, controlled-release formulation of hydrocodone for the treatment of moderate to severe pain in patients requiring around-the-clock opioid therapy for an extended period of time.

10 Feb 2011

Mallinckrodt receives FDA approval for Fentanyl Transdermal System patch ANDA

Covidien, a leading global provider of healthcare products, today announced that Mallinckrodt Inc., a Covidien company, has received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for its Fentanyl Transdermal System (FTS) patch. Covidien is the largest supplier of controlled pain medications in the United States based on number of prescriptions.

10 Feb 2011

Momenta reports fourth quarter 2010 net income of $36.3M vs. $14.7M net loss for fourth quarter 2009

Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex drugs, today reported its financial results for the fourth quarter and year ended December 31, 2010.

10 Feb 2011

BioCryst reports net loss of $9.1M for fourth quarter 2010 vs. $15.2M net income for fourth quarter 2009

BioCryst Pharmaceuticals, Inc. announced financial results for the fourth quarter and full year ended December 31, 2010.

10 Feb 2011

Alexion fourth quarter net product sales of Soliris increases to $156.0 million

Alexion Pharmaceuticals, Inc. today announced financial results for the quarter and year ended December 31, 2010. For the three months ended December 31, 2010, Alexion Pharmaceuticals, Inc. reported net product sales of Soliris® (eculizumab) of $156.0 million, reflecting strong additions of new patients, compared to $110.6 million for the same period in 2009.

10 Feb 2011

Alexion acquires investigational therapy for MoCD Type A ultra-rare genetic disorder from Orphatec

Alexion Pharmaceuticals, Inc. announced that it has purchased patents and assets from Germany-based Orphatec Pharmaceuticals GmbH related to an investigational therapy for patients with molybdenum cofactor deficiency (MoCD) Type A, a devastating ultra-rare genetic disorder characterized by severe brain damage and rapid death in newborns.

10 Feb 2011

Phospholipid membranes demonstrate ability to absorb lanthanum cations

University of Granada scientists and the Spanish Higher Institute for Scientific Research (CSIC) have made significant progress in understanding lipid membranes, which are extensively employed in the development of cosmetic and drug products, and which have potential application in the field of nanotechnology.

10 Feb 2011

Rhabdomyolysis episode at University of Iowa signals a public health crisis

On January 26, 2011, it was reported that 13 University of Iowa football players were affected so severely by rhabdomyolysis that they were hospitalized. Occurrences of rhabdomyolysis—muscle breakdown—are so rare that it suggests an additional causal factor, such as a drug.

10 Feb 2011

Idenix announces updates on HCV and HIV clinical development programs

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced updates to three clinical development programs.

10 Feb 2011

Diamyd's NP2 Enkephalin Phase II study in cancer pain posted on ClinicalTrials.gov

Diamyd Medical´s US Phase II clinical trial, evaluating the ability of the candidate drug NP2 Enkephalin to reduce cancer pain, is posted on the ClinicalTrials.gov website.

10 Feb 2011

Benson Group listed on 'Europe's 500' top growth companies

Europe's 500, the association of top European growth entrepreneurs met at the European Parliament in Brussels on February 3rd for the European Growth Summit 2011. An integral part of the event, the "Europe's 500" awards ceremony honoured the top-growth-companies in Europe, and released a list of the 200 fastest-growing, job-creating businesses.

10 Feb 2011

UCSD: Medication education can help patients with diabetes better stick to drug treatment plans

Researchers at the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of California, San Diego say that medication education is a key factor in helping patients with diabetes better stick to their drug treatments plans.

10 Feb 2011

US District Court rules in favor of Watson in generic Mucinex patent infringement suit

Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that the United States District Court for the Southern District of Florida has ruled that Watson's generic versions of Mucinex®, Mucinex® D and Mucinex® DM (Guaifenesin, Dextromethorphan HBr/ Guaifenesin, and Pseudoephedrine/Guaifenesin) Extended-Release products, do not infringe U.S. Patent No. 6,372,252.

10 Feb 2011

Physicist creates technology that may enhance pharma industry's early drug discovery capabilities

A Purdue physicist has created technology to detect motion inside three-dimensional tumor spheroids, which may enhance the pharmaceutical industry's early drug discovery capabilities.

10 Feb 2011

EHSI applauds promising new stem cell treatment for Parkinson's

Emerging Healthcare Solutions, Inc. applauded a new study today revealing a promising new stem cell treatment for Parkinson's.

10 Feb 2011

Healthline Networks, MedHelp expand strategic partnership

Healthline Networks, the leading provider of intelligent health information services, and MedHelp, the world's largest health social network and the leading provider of online and mobile health applications, today announced an expansion of their strategic partnership, naming Healthline as the exclusive third-party representative for custom content programs for selected pharmaceutical advertisers on MedHelp.

10 Feb 2011

Teva reports positive results from QNAZE Phase III perennial allergic rhinitis trial

Teva Pharmaceutical Industries Ltd. today announced results from a Phase III study of QNAZE™ (beclomethasone dipropionate [BDP]) HFA, its nasal aerosol corticosteroid in development for the treatment of perennial allergic rhinitis (PAR) and seasonal allergic rhinitis (SAR).

10 Feb 2011

Cephalon to acquire Alba Therapeutics

Cephalon, Inc. and Alba Therapeutics Corporation, a privately held biopharmaceutical company, today announced that the companies have signed an agreement providing Cephalon with an option to purchase all of Alba's assets relating to larazotide acetate, a tight junction modulator, progressing toward a Phase IIb clinical trial for the treatment of celiac disease.

10 Feb 2011

Targacept initiates TC-6987 Phase 2 study in patients with asthma, Type 2 diabetes

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced the initiation of separate Phase 2 clinical studies of its product candidate TC-6987 in disorders characterized by inflammation, one in asthma and one in Type 2 diabetes.

9 Feb 2011

Pharmaceuticals News and Research

Gilead resubmits NDA for single-tablet regimen of Truvada/TMC278

Zogenix completes enrollment in ZX002 Phase 3 study in opioid-experienced adults with moderate to severe pain

Mallinckrodt receives FDA approval for Fentanyl Transdermal System patch ANDA

Momenta reports fourth quarter 2010 net income of $36.3M vs. $14.7M net loss for fourth quarter 2009

BioCryst reports net loss of $9.1M for fourth quarter 2010 vs. $15.2M net income for fourth quarter 2009

Alexion fourth quarter net product sales of Soliris increases to $156.0 million

Alexion acquires investigational therapy for MoCD Type A ultra-rare genetic disorder from Orphatec

Phospholipid membranes demonstrate ability to absorb lanthanum cations

Rhabdomyolysis episode at University of Iowa signals a public health crisis

Idenix announces updates on HCV and HIV clinical development programs

Diamyd's NP2 Enkephalin Phase II study in cancer pain posted on ClinicalTrials.gov

Benson Group listed on 'Europe's 500' top growth companies

UCSD: Medication education can help patients with diabetes better stick to drug treatment plans

US District Court rules in favor of Watson in generic Mucinex patent infringement suit

Physicist creates technology that may enhance pharma industry's early drug discovery capabilities

EHSI applauds promising new stem cell treatment for Parkinson's

Healthline Networks, MedHelp expand strategic partnership

Teva reports positive results from QNAZE Phase III perennial allergic rhinitis trial

Cephalon to acquire Alba Therapeutics

Targacept initiates TC-6987 Phase 2 study in patients with asthma, Type 2 diabetes

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