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Neurologix reports net loss of $13.5M for year ended December 31, 2009

Neurologix, Inc., a biotechnology company engaged in the development of innovative therapies for the brain and central nervous system, today announced its financial results for the year ended December 31, 2009.

26 Mar 2010

ADVENTRX Pharmaceuticals to meet FDA to review its NDA for ANX-530

ADVENTRX Pharmaceuticals, Inc. today announced that it will meet the U.S. Food and Drug Administration in Washington D.C. during the last week of April 2010 to review the Company's New Drug Application for ANX-530 (vinorelbine injectable emulsion) and the FDA's refusal-to-file letter.

26 Mar 2010

FDA Advisory Committee to review VIVUS' NDA for Qnexa

VIVUS, Inc. today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration is tentatively scheduled to review the Company's New Drug Application for Qnexa® for the treatment of obesity on July 15, 2010.

26 Mar 2010

FDA grants tentative approval for Teva Pharmaceutical Industries' generic Argatroban ANDA

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market a generic version of the anticoagulant, Argatroban® injection, 100mg/mL.

26 Mar 2010

Santarus enrolls 510 patients in Phase III clinical program for budesonide MMX

Santarus, Inc., a specialty biopharmaceutical company, today announced the completion of enrollment of 510 patients in a U.S. Phase III clinical study to evaluate budesonide MMX® administered over eight weeks for the induction of remission of mild or moderate active ulcerative colitis. This is the second Phase III clinical study being conducted in collaboration with Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals SpA, as part of the budesonide MMX Phase III clinical program for U.S. registration.

26 Mar 2010

Hana Biosciences reports net loss of $5M for fourth quarter 2009

Hana Biosciences Inc., a biopharmaceutical company focused on strengthening the foundation of cancer care, today reported financial results for the fourth quarter and year ended December 31, 2009, and provided a corporate update.

26 Mar 2010

Isotechnika Pharma releases fourth quarter financial results; reviews operational and scientific highlights for 2009

Isotechnika Pharma Inc. has released its financial results for the fourth quarter and year ended December 31, 2009 and provided a review of the Company's operational and scientific highlights for 2009

25 Mar 2010

SCOLR Pharma's total revenue dips 2% in 2009, but significant improvements in operating expenses

SCOLR Pharma, Inc. today reported financial results for the twelve months ended December 31, 2009. The Company will host a live conference call on March 31, 2010, at 11:30 a.m. (Eastern Standard Time).

25 Mar 2010

Xifaxan drug receives FDA approval

The U.S. Food and Drug Administration today approved the use of Xifaxan for reduction in the risk of the recurrence of overt hepatic encephalopathy (HE) in patients with advanced liver disease.

25 Mar 2010

Æterna Zentaris announces 2009 financial and operating results

Æterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today reported financial and operating results as at and for the fourth quarter and the full year ended December 31, 2009.

24 Mar 2010

Transcept Pharmaceuticals receives second patent for Intermezzo formulation

Transcept Pharmaceuticals, Inc. today announced that the second patent covering the composition and use of Intermezzo® (zolpidem tartrate sublingual tablet), the lead Transcept product candidate, has been issued by the United States Patent and Trademark Office.

24 Mar 2010

EMA validates InterMune's pirfenidone MAA for IPF

InterMune, Inc. today announced that the company's Marketing Authorization Application (MAA), submitted on March 2 seeking approval of pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF) in adults, was validated by the European Medicines Agency (EMA). Validation of the MAA by the EMA indicates that the application is complete and that the review process will begin on March 24. The proposed trade name for pirfenidone in both the United States and Europe is Esbriet®.

23 Mar 2010

Inhibitex announces net loss of $4.7M for fourth-quarter 2009

Inhibitex, Inc. today announced its financial results for the fourth quarter and year ended December 31, 2009 and provided an update on various corporate developments.

23 Mar 2010

Clinical Data completes NDA submission for vilazodone

Clinical Data, Inc., today announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vilazodone for the treatment of major depressive disorder (MDD). Vilazodone is a dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist. The Company expects that the NDA submission, if accepted, will be subject to a standard review.

23 Mar 2010

Ipsen, GTx expand partnership for toremifene 80 mg

Ipsen today announced the expansion of their partnership for the development and commercialization of toremifene 80 mg for the reduction of fractures in men with advanced prostate cancer on androgen deprivation therapy (ADT) and toremifene 20 mg for the prevention of prostate cancer in high risk patients with High Grade Prostatic Intraepithelial Neoplasia lesions (HGPIN).

23 Mar 2010

FDA's ODAC voted to review T315I mutation prior to approval of OMAPRO

ChemGenex Pharmaceuticals Limited announced today that the U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee voted 7-1 that a validated test to identify the T315I mutation should be reviewed by the FDA prior to approval of OMAPRO™ (omacetaxine mepesuccinate).

23 Mar 2010

LPI's ANDA for Eszopiclone tablets receives tentative approval from USFDA

Lupin Pharmaceuticals, Inc. announced today that it has received tentative approval for the Company's Abbreviated New Drug Application for Eszopiclone tablets, 1 mg, 2 mg and 3 mg from the U.S. Food and Drug Administration.

23 Mar 2010

BEMA Granisetron development program: BDSI announces positive meeting with FDA

BioDelivery Sciences International, Inc. announced the positive outcome of a meeting with the FDA on the development program for BEMA Granisetron, the company’s potential treatment for the prevention of nausea and vomiting associated with cancer therapy. FDA concurred with BDSI’s plans to pursue a development program based on clinical pharmacokinetic data for a 505(b)(2) New Drug Application.

22 Mar 2010

CHMP issues positive opinion recommending approval of Tarceva as monotherapy for NSCLC

OSI Pharmaceuticals, Inc. announced today that its international partner for Tarceva® (erlotinib), Roche, informed OSI that the European Committee for Medicinal Products for Human Use has issued a positive opinion recommending approval of Tarceva as monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with stable disease following four cycles of standard platinum-based first-line chemotherapy.

19 Mar 2010

A.P. Pharma's NDA for APF530 in prevention of CINV: FDA issues Complete Response Letter

A.P. Pharma, Inc., a specialty pharmaceutical company, today announced that it received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application for APF530 in the prevention of both acute and delayed onset chemotherapy-induced nausea and vomiting.

19 Mar 2010