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NIAID scientists confirm antiviral activity of two lead compounds against HPV

Tamir Biotechnology, Inc. announced today that scientists supported by the National Institute of Allergy and Infectious Diseases (NIAID) reported test results confirming two of our lead compounds showed excellent in vitro antiviral activity and no cellular toxicity at dose levels tested for Human Papillomavirus (HPV).

30 Nov 2010

Alza files patent infringement suit against Impax in connection with Concerta

Impax Laboratories, Inc. today confirms that Alza Corporation has filed suit for patent infringement against Impax in the United States District Court for the District of Delaware in connection with Concerta® (methylphenidate hydrochloride) extended-release 54 mg tablets.

30 Nov 2010

Spectrum's FUSILEV sNDA accepted by FDA for review

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the complete response regarding its supplemental New Drug Application (sNDA) for FUSILEV® (levoleucovorin) for Injection for treatment of patients with advanced metastatic colorectal cancer.

29 Nov 2010

Amarin reports top-line results from AMR101 Phase 3 trial for treatment of high triglycerides

Amarin Corporation plc, a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reported positive, statistically significant top-line results from the MARINE study, its first Phase 3 clinical trial of lead drug candidate AMR101.

29 Nov 2010

NovaBay announces meeting with FDA to discuss Aganocide compound for impetigo

NovaBay Pharmaceuticals, Inc., a clinical stage biotechnology company developing first-in-class, anti-infective compounds for the treatment and prevention of antibiotic-resistant infections, announces a successful meeting with the US Food and Drug Administration (FDA) to discuss the Company's clinical development of its Aganocide compound NVC-422, intended for use in the treatment of impetigo.

29 Nov 2010

Affymax, Takeda to regulate peginesatide drug for treating anemia in CRF patients

Affymax, Inc. and Takeda Pharmaceutical Company Limited , today announced that following pre-New Drug Application (NDA) discussions with the U.S. Food and Drug Administration (FDA), the companies will move forward with their regulatory strategy for the investigational drug, peginesatide, for the treatment of anemia in chronic renal failure (CRF) patients on dialysis in the United States.

29 Nov 2010

Pfizer, Protalix announce marketing authorization submission in Europe for taliglucerase alfa

Pfizer Inc. and Protalix BioTherapeutics, Inc. today announced the submission of a Marketing Authorization Application to the European Medicines Agency for taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD)for the treatment of Gaucher disease. Taliglucerase alfa was granted Orphan Designation by the European Commission for the treatment of Gaucher disease on March 23, 2010.

29 Nov 2010

Impax initiates patent challenge in connection with SIMCOR

Impax Laboratories, Inc. today confirms that it has initiated a challenge of patents listed in connection with SIMCOR® (niacin/simvastatin) extended-release tablets, 1000/20 mg.

26 Nov 2010

FDA extends review period of Cladribine Tablets for MS therapy

EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany, announced today that the U.S. Food and Drug Administration (FDA) has extended its review period for Cladribine Tablets as a therapy for relapsing forms of multiple sclerosis (MS) by three months to February 28, 2011.

26 Nov 2010

USFDA grants Sun Pharma tentative marketing approval for generic Cymbalta

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary a tentative approval for an Abbreviated New Drug Application (ANDA) to market a generic version of Cymbalta®, duloxetine hydrochloride delayed-release capsules.

24 Nov 2010

Gilead submits Truvada/TMC278 single-tablet regimen NDA to FDA

Gilead Sciences, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of 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. If approved, this would be the second product that contains a complete HIV treatment regimen in a single once-daily tablet.

23 Nov 2010

Vertex submits NDA for telaprevir for treating hepatitis C

Vertex Pharmaceuticals Incorporated announced that it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for telaprevir, Vertex's investigational treatment for people with hepatitis C.

23 Nov 2010

Apricus files protocol of PrevOnco Phase 3 clinical trial for FDA SPA program

Apricus Biosciences, Inc., today announced that it has filed the protocol for a proposed Phase 3 clinical trial of PrevOnco, its proprietary treatment for hepatocellular carcinoma (liver cancer), with the U.S. Food and Drug Administration (FDA).

23 Nov 2010

Impax initiates challenge of patents relating to WELCHOL

Impax Laboratories, Inc. today confirms that it has initiated a challenge of patents listed by Daiichi Sankyo, Inc. in connection with its WELCHOL® (Colesevelam HCl) for Oral Suspension, 3.75 gm/packet and 1.875 gm/packet.

22 Nov 2010

FDA grants Impax tentative approval for generic Cymbalta NDA

Impax Laboratories, Inc. confirmed that the U.S. Food and Drug Administration (FDA) has granted tentative approval of the Company's Abbreviated New Drug Application for generic version of Cymbalta® delayed-release (duloxetine hydrochloride) 20, 30 and 60 mg capsules.

22 Nov 2010

NEXTERONE Premixed Injection uses CyDex Captisol technology platform

CyDex Pharmaceuticals, Inc. today announced that Prism Pharmaceuticals' NEXTERONE (amiodarone HCL) Premixed Injection, which recently received supplemental new drug application (sNDA) approval from the U.S. Food and Drug Administration, makes use of the patent-protected CyDex Captisol technology platform.

20 Nov 2010

CMS grants Qutenza J-code to NeurogesX

NeurogesX, Inc. a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced that the Centers for Medicare and Medicaid Services (CMS) has granted a unique, Level II Health Care Common Procedural Coding System (Level II HCPCS), commonly referred to as a J-code, for Qutenza (capsaicin) 8% patch.

19 Nov 2010

Spectrum to present four key belinostat data for solid cancers at ASH annual meeting

Spectrum Pharmaceuticals, Inc., a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced four key belinostat data presentations at the 52nd Annual Meeting of the American Society of Hematology (ASH), being held at the Orange County Convention Center in Orlando, Florida, December 4-7, 2010.

19 Nov 2010

Impax announces positive top-line results of Phase III IPX066 study for Parkinson's disease

Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc., today announced positive top-line results of the APEX-PD Phase III clinical study with IPX066 in Parkinson's disease (PD). IPX066 is a novel extended release carbidopa-levodopa product.

19 Nov 2010

FDA approves new drug application for NEXTERONE Premixed Injection

Prism Pharmaceuticals, Inc. announced today that the U.S. Food & Drug Administration has approved the supplemental new drug application for NEXTERONE (amiodarone HCl) Premixed Injection, the first and only premixed intravenous (IV) bag formulation of the antiarrhythmic agent amiodarone IV.

19 Nov 2010