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Celgene's ISTODAX sNDA granted FDA Priority Review classification for progressive/relapsed PTCL

Celgene Corporation today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review classification to its Supplemental New Drug Application (sNDA) regarding ISTODAX (romidepsin) for injection for the treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy.

28 Feb 2011

FDA approves Matrix Labs generic Neurontin ANDA

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Gabapentin Capsules USP, 100 mg, 300 mg and 400 mg, the generic version of Pfizer's Neurontin® Capsules used to treat a painful complication of shingles.

28 Feb 2011

Takeda receives FDA approval for EDARBI to treat hypertension in adults

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that the U.S. Food and Drug Administration approved EDARBI for the treatment of hypertension, or high blood pressure, in adults.

27 Feb 2011

Warner Chilcott fourth quarter revenue increases 1% to $694.4 million

Warner Chilcott plc today announced its results for the quarter and year ended December 31, 2010. As discussed more fully below, our financial position and results of operations in the quarter ended December 31, 2010 as compared to the prior year quarter were significantly impacted by several important transactions in 2009 and 2010.

25 Feb 2011

Protalix receives FDA CRL for taliglucerase alfa NDA for Gaucher disease

Protalix BioTherapeutics, Inc., announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Company's New Drug Application (NDA) for taliglucerase alfa for the treatment of Gaucher disease. Taliglucerase alfa is a plant-cell expressed form of glucocerebrosidase (GCD).

25 Feb 2011

Journal of Clinical Virology publishes positive outcome from CMX001 treatment against AdV infection

Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, today announced the publication of the first reported case in which adenovirus infection was successfully eradicated following treatment with its broad-spectrum antiviral drug, CMX001.

25 Feb 2011

Salix anticipates receipt of FDA's CRL for XIFAXAN 550 mg sNDA

Salix Pharmaceuticals, Ltd. today announced that based on a telephone conversation with the U.S. Food and Drug Administration held last evening, the Company anticipates receiving a Complete Response Letter on or before the March 7, 2011 PDUFA goal date for the supplemental New Drug Application for XIFAXAN 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome and IBS-related bloating.

25 Feb 2011

BioCryst receives HHS contract to complete peramivir Phase 3 study in patients with influenza

BioCryst Pharmaceuticals, Inc. announced that it has been awarded a $55.0 million contract modification by the U.S. Department of Health & Human Services intended to fund to completion the Phase 3 development of its neuraminidase inhibitor, intravenous peramivir, for the treatment of patients hospitalized with influenza.

25 Feb 2011

Takeda submits NDA to FDA for fixed-dose combination of azilsartan medoxomil plus CLD to treat hypertension

Takeda Pharmaceutical Company Limited announced today that Takeda Global Research & Development Center, Inc. U.S., submitted a New Drug Application to the U.S. Food and Drug Administration for an investigational fixed-dose combination of azilsartan medoxomil plus chlorthalidone for the treatment of hypertension, or high blood pressure.

24 Feb 2011

EpiCept 2010 fourth quarter net loss is $0.06 per share

EpiCept Corporation today announced operating and financial results for the fourth quarter and full year ended December 31, 2010, and provided an update on its key business initiatives.

24 Feb 2011

Noven claims patent infringement over Vivelle-Dot, files lawsuit against Mylan

Noven Pharmaceuticals, Inc. announced today that it has filed a lawsuit in the U.S. District Court for the Southern District of New York against Mylan Technologies Inc. ("Mylan") claiming infringement of certain Noven patents (the "Patents") by Mylan.

23 Feb 2011

KemPharm commences KP201 Phase 1 trial for pain

KemPharm, Inc. today announced that it has commenced a Phase 1 clinical trial in healthy volunteers with KP201, its novel abuse deterrent prodrug of hydrocodone for pain. KP201 is a new chemical entity and is the most advanced opioid-based lead candidate in KemPharm's emerging pipeline.

22 Feb 2011

FDA refuses Delcath's chemosaturation delivery system NDA filing

Delcath Systems, Inc. announced today that the Company has received a "refusal to file" letter from the U.S. Food & Drug Administration for the New Drug Application for its proprietary chemosaturation system used in the treatment of patients with metastatic melanoma in the liver through the percutaneous intra-arterial administration of melphalan hydrochloride.

22 Feb 2011

QRxPharma granted FDA pre-NDA meeting, further phase II data released

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today the granting of a pre-New Drug Application (NDA) meeting with the United States Food and Drug Administration (FDA) and successful completion of its third pivotal Phase 3 registration trial (study 009) for immediate-release MoxDuo.

20 Feb 2011

Protalix: New data from taliglucerase alfa, oral GCD trials to be presented at Lysosomal Disease Network Symposium

Protalix BioTherapeutics, Inc., announced today that new clinical data from the switchover trial of taliglucerase alfa in Gaucher disease patients and preclinical data on oral enzyme glucocerebrosidase (oral GCD) will be presented today at the 7th Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2011 in Las Vegas, Nevada.

19 Feb 2011

Impax' NDA for generic version of Adoxa receives final FDA approval

Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration has granted final approval of the Company's Abbreviated New Drug Application for its generic version of Adoxa.

18 Feb 2011

Apricus Bio in discussions with FDA for PrevOnco SPA Phase III protocol

Apricus Biosciences, Inc., announced today that it is currently in discussions with the U.S. Food and Drug Administration ("FDA") relating to the PrevOnco™ Special Protocol Assessment ("SPA") Phase III protocol submitted by the Company in December 2010.

18 Feb 2011

ADVENTRX updates ANX-514 candidate for FDA approval

ADVENTRX Pharmaceuticals, Inc. today provided an update on its product candidate, ANX-514, its polysorbate 80-free formulation of docetaxel.

16 Feb 2011

CTI's fourth quarter net loss increases to $34.1 million

Cell Therapeutics, Inc. today reported recent accomplishments and financial results for the fourth quarter and year ended December 31, 2010.

16 Feb 2011

Aeolus receives BARDA contract for AEOL 10150 drug development against ARS

Aeolus Pharmaceuticals, a biopharmaceutical company developing a new class of broad spectrum catalytic antioxidant compounds that reduce oxidative stress, inflammation, and subsequent tissue damage-signaling cascades resulting from radiation exposure, today announced that the Biomedical Advanced Research and Development Authority, part of the Department of Health and Human Services, has awarded Aeolus a contract for the advanced development of AEOL 10150 as a medical countermeasure against the pulmonary sub-syndrome of acute radiation syndrome.

16 Feb 2011