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FDA accepts filing of Lux Biosciences' NDA for Luveniq and grants application priority review

Lux Biosciences, Inc. today announced that the U.S. Food and Drug Administration has accepted the filing of the company's New Drug Application for Luveniq™ (oral voclosporin) and has granted the application priority review.

31 Mar 2010

NKF 2010 Spring Clinical Meeting: Multiple posters on Hematide/peginesatide to be presented

Affymax, Inc. and Takeda Pharmaceuticals Global Research & Development Center, Inc., U.S., today announced multiple posters on Hematide™/peginesatide have been accepted for presentation at the National Kidney Foundation (NKF) 2010 Spring Clinical Meeting taking place April 13-17, 2010 in Orlando, Florida. Hematide is an investigational agent for the treatment of anemia in chronic renal failure (also referred to as renal anemia).

31 Mar 2010

NeurOp and Bristol-Myers Squibb announce drug discovery collaboration

NeurOp Corporation today announced a collaboration with Bristol-Myers Squibb Company (NYSE: BMY) focused upon the development of NeurOp's proprietary small molecules for use in the treatment of major depression and other central nervous system disorders.

31 Mar 2010

CVS Caremark awarded Specialty Pharmacy accreditation from URAC

CVS Caremark announced today that it has been awarded Specialty Pharmacy accreditation from URAC, a Washington, DC-based health care accrediting organization that establishes quality standards for the health care industry.

31 Mar 2010

Hsp90 inhibitors may help fight cardiovascular disease, say researchers

New drugs that are helping fight a multi-front war on cancer may do the same for cardiovascular disease, Medical College of Georgia researchers said.

31 Mar 2010

Beta-blockers can reduce cancer spread in patients with breast tumours

The risk of cancer spreading in patients with breast tumours can be lowered with the use of beta-blockers, research presented at the European Breast Cancer Conference in Barcelona suggests.

31 Mar 2010

NMS Labs launches test to evaluate the efficacy of Milnacipran

NMS Labs launches another unique test suitable for the evaluation of toxicity vs. efficacy, the potential for physicians to establish therapeutic drug monitoring of individual patients, and the assessment of drug diversion of a new pain management drug therapy.

31 Mar 2010

Depomed licensee submits DM-1796 NDA for management of PHN

Depomed, Inc. today announced that its licensee has submitted a New Drug Application (NDA) for DM-1796 to the U.S. Food and Drug Administration (FDA) for the management of postherpetic neuralgia (PHN), or pain after shingles. DM-1796 is an investigational, extended release, once-daily tablet formulation of gabapentin designed to reduce dosing frequency and have a low incidence of side effects.

31 Mar 2010

Nutra Pharma's Cobroxin pain reliever now available at CVS stores

Nutra Pharma Corp., a biotechnology company that is developing treatments for Adrenomyeloneuropathy, HIV and Multiple Sclerosis, has announced today that its over-the-counter pain reliever, Cobroxin, is now available for purchase in CVS.

31 Mar 2010

FDA grants priority review status for Isotechnika Pharma's voclosporin

Isotechnika Pharma Inc. today announced that the New Drug Application (NDA) for the Company's next generation calcineurin inhibitor, voclosporin, has been accepted for priority review as filed by the U.S. Food and Drug Administration (FDA). The application was submitted by Isotechnika's partner, Lux Biosciences, Inc.

31 Mar 2010

Patients switching to Victoza experience further reductions in A1c and weight loss

Diabetes Care published online the results of the Novo Nordisk LEAD™ 6 extension study, which evaluated the efficacy and safety of switching from exenatide, which is taken twice a day, to once-daily Victoza®. Results show that when added to oral antidiabetes drugs, patients who switched from exenatide to Victoza experienced further reductions in A1c and weight loss.

31 Mar 2010

Study indicates estrogenic drug could help treat schizophrenia

An estrogenic drug that influences neurotransmitter and neuronal systems in the brain is showing promise as an effective therapy for women who suffer from schizophrenia.

31 Mar 2010

Study evaluates OCP treatment to prevent endometrioma recurrence

Ovarian endometriomas, better known as ovarian 'chocolate' cysts for the brown liquid they contain, can be easily removed by surgery. However, recurrence is common, which can cause ongoing pain and complications. A study evaluated for Faculty of 1000 suggests a simple and effective remedy - the oral contraceptive pill.

31 Mar 2010

Asclera injection receives FDA approval

The U.S. Food and Drug Administration today approved Asclera (polidocanol) injection for the treatment of small types of abnormally swollen or twisted veins called varicose veins.

31 Mar 2010

FDA issues Complete Response Letter for CERTRIAD NDA

AstraZeneca and Abbott announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) for the New Drug Application (NDA) for CERTRIAD™ (rosuvastatin / fenofibric acid delayed release) Capsules.

31 Mar 2010

Access Pharmaceuticals, bioRASI sign collaborative agreement to develop Cobalamin oral insulin product

ACCESS PHARMACEUTICALS, INC. signed a collaborative development agreement with bioRASI, LLC, a full-service global CRO specializing in the accelerated development of novel therapeutics, to facilitate clinical development for its Cobalamin™-based oral insulin and other Cobalamin-based products.

31 Mar 2010

Ikaria Holdings acquires NDA and IND application for LUCASSIN drug

Ikaria Holdings, Inc. announced today that it has acquired the New Drug Application (NDA) and the Investigational New Drug (IND) application to LUCASSIN® (terlipressin for injection) from Orphan Therapeutics, assuming all future development and ownership of the drug in North America and Australia.

31 Mar 2010

Hospira acquires Orchid's injectables formulations business

Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced it has completed the acquisition of the generic injectable pharmaceuticals business of Orchid Chemicals & Pharmaceuticals Ltd., a leading Indian pharmaceuticals company, for approximately $400 million.

31 Mar 2010

Savient Pharmaceuticals' resubmission of BLA for KRYSTEXXA accepted for FDA review

Savient Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has acknowledged receipt of and accepted for review the March 15, 2010 resubmission of the Biologics License Application for KRYSTEXXA™ (pegloticase), a treatment for chronic gout in patients refractory to conventional therapy.

30 Mar 2010

Mood altering effects of Phenytoin

Phenytoin is a well known antiepileptic agent widely used throughout the world. Recent clinical studies in patients with bipolar disorder have suggested that, as for other anticonvulsant drugs commonly used in the treatment of bipolar patients including valproate and carbamazepine, phenytoin may have mood-stabilizing effects in addition to its well-known anticonvulsant properties.

30 Mar 2010