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Novelos Therapeutics to conclude pivotal Phase 3 trial in advanced non-small cell lung cancer

Novelos Therapeutics, Inc., a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that the 725th event (patient death) has been reached in its pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) studying its lead product, NOV-002, in combination with first-line chemotherapy.

8 Jan 2010

FDA issues Fast Track Designation to Sopherion Therapeutics' Myocet

Sopherion Therapeutics, LLC, a biopharmaceutical company focused on the development and commercialization of anti-cancer therapies, announced today that it has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for nonpegylated liposomal doxorubicin (Myocet(TM)) for first-line therapy of HER2 positive metastatic breast cancer.

7 Jan 2010

Positive results from phase 2 study evaluating the safety and efficacy of Qnexa announced

VIVUS, Inc. today announced positive results from a phase 2 study evaluating the safety and efficacy of Qnexa®, an investigational drug, for the treatment of obstructive sleep apnea (OSA). VIVUS recently completed phase 3 development of Qnexa for the treatment of obesity and submitted a New Drug Application (NDA) to the FDA for that indication.

7 Jan 2010

ProFibrix B.V. receives loan up to $7.4 million to develop its new hemostat Fibrocaps

ProFibrix B.V., a leader in the development of innovative products for hemostasis and regenerative medicine, today announced that SenterNovem, an agency of the Dutch Ministry of Economic Affairs, has granted the company a loan under its new Innovation Credit scheme of potentially up to EUR 5 million to finance the further clinical development of its unique new hemostat Fibrocaps(TM).

7 Jan 2010

Alnylam Pharmaceuticals receives payment from Roche to initiate pre-IND studies for RNAi therapeutics

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has received a milestone payment from its partner Roche related to initiation of pre-IND (investigational new drug application) studies for an RNAi therapeutics product candidate.

7 Jan 2010

Watson Laboratories files ANDA to seek FDA's approval to market Nuvigil

Watson Pharmaceuticals, Inc., a leading global specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc., a Nevada Corporation, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its 50 mg, 100 mg, 150mg, 200 mg, and 250mg strength armodafinil tablets prior to the expiration of patents owned by Cephalon France.

7 Jan 2010

Oral cladribine to be the first oral disease-modifying multiple sclerosis therapy despite receiving RTF letter

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a recent "refuse to file" (RTF) letter issued by the Food and Drug Administration (FDA) regarding Merck Serono's oral cladribine has heightened the competition between oral cladribine and its primary competitor, Novartis/Mitsubishi Tanabe's FTY-720 (fingolimod), to be the first oral disease-modifying multiple sclerosis therapy to reach the market in the United States.

6 Jan 2010

Keryx Biopharmaceuticals reaches SPA agreement for Phase 3 clinical program for Zerenex

Keryx Biopharmaceuticals, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 clinical program for Zerenex(TM) (ferric citrate), its iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD).

6 Jan 2010

Pharsight releases Phoenix NLME and Phoenix Connect

Pharsight, a market-leading provider of software and scientific services to improve productivity and decision-making in clinical drug development, today announced that it has released two new data analysis tools; Phoenix NLME and Phoenix Connect.

6 Jan 2010

BioVectra signs agreements with Sandoz to commercialize and market Docetaxel

BioVectra Inc. announced today it has signed agreements with Sandoz Inc. of Princeton, New Jersey, for Sandoz to commercialize and market the Abbreviated New Drug Application (ANDA) for Docetaxel for injection, the generic version of Taxotere®, developed by BioVectra.

6 Jan 2010

MonoSol Rx signs new licensing and development agreement with Strativa Pharmaceuticals

MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in proprietary pharmaceutical film products, announced today that it has entered into a new licensing and development agreement that grants the option to develop three new products with Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. ( PRX).

6 Jan 2010

Further stay of Cipher's NDA for CIP-TRAMADOL ER terminated

Cipher Pharmaceuticals Inc. today announced a final judgment (the "Cipher Judgment") has been entered in favour of Cipher in relation to pending patent litigation with Purdue Pharma Products L.P. and Napp Pharmaceutical Group Ltd. (together "Purdue") in the United States District Court for the Eastern District of Virginia (the "Court").

5 Jan 2010

VELCADE sNDA receives FDA approval

Millennium: The Takeda Oncology Company today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE, which expands the label to include long-term (median follow-up 36.7 months) overall survival (OS) data from the landmark VISTA trial and provides specific dosing recommendations for patients with hepatic impairment. The VISTA trial examined the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

5 Jan 2010

NeoPharm submits IL13-PE38QQR IND for the treatment of IPF

NeoPharm, Inc., announced today that it has filed an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) for IL13-PE38QQR (IL13-PE) for the treatment of Idiopathic Pulmonary Fibrosis (IPF). IPF is the most deadly disease of the lungs in humans with very high morbidity. There is currently no proven effective treatment for the cure of this disease.

5 Jan 2010

DSPA submits lurasidone NDA to the FDA

Dainippon Sumitomo Pharma America, Inc. (DSPA), a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. (DSP), submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lurasidone, an investigational atypical antipsychotic agent for the treatment of schizophrenia. The application, submitted on December 30, 2009, includes data from more than 40 clinical studies involving more than 2,500 lurasidone-treated patients.

4 Jan 2010

FDA grants Priority Review designation for InterMune's NDA for pirfenidone

InterMune, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review and granted Priority Review designation for the company's New Drug Application (NDA) for pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF).

4 Jan 2010

ADVENTRX Pharmaceuticals submits a NDA for its vinorelbine injectable emulsion

ADVENTRX Pharmaceuticals, Inc. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate ANX-530 (vinorelbine injectable emulsion).

4 Jan 2010

FDA evaluates Phase III randomized trial in acute myeloid leukemia

VION PHARMACEUTICALS, INC., announced today that the U.S. Food and Drug Administration ("FDA") had responded to its Special Protocol Assessment ("SPA") request to evaluate the Phase III randomized trial HOVON AML 92 sponsored by the Dutch-Belgian Cooperative Group for Hematology Oncology ("HOVON") of its lead product Onrigin(TM).

31 Dec 2009

FDA accepts NDA review for new anticonvulsant drug

The U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) seeking marketing approval for Retigabine. In addition, the European Medicines Agency (EMEA) confirmed on November 17, 2009 that the MAA (Marketing Authorization Application) was successfully validated thus enabling the MAA review to commence.

30 Dec 2009

Biodel submits NDA to FDA for clearance to market VIAject

Biodel, Inc. announced today that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for clearance to market VIAject® as a treatment for diabetes.

30 Dec 2009

New Drug Application News and Research

Novelos Therapeutics to conclude pivotal Phase 3 trial in advanced non-small cell lung cancer

FDA issues Fast Track Designation to Sopherion Therapeutics' Myocet

Positive results from phase 2 study evaluating the safety and efficacy of Qnexa announced

ProFibrix B.V. receives loan up to $7.4 million to develop its new hemostat Fibrocaps

Alnylam Pharmaceuticals receives payment from Roche to initiate pre-IND studies for RNAi therapeutics

Watson Laboratories files ANDA to seek FDA's approval to market Nuvigil

Oral cladribine to be the first oral disease-modifying multiple sclerosis therapy despite receiving RTF letter

Keryx Biopharmaceuticals reaches SPA agreement for Phase 3 clinical program for Zerenex

Pharsight releases Phoenix NLME and Phoenix Connect

BioVectra signs agreements with Sandoz to commercialize and market Docetaxel

MonoSol Rx signs new licensing and development agreement with Strativa Pharmaceuticals

Further stay of Cipher's NDA for CIP-TRAMADOL ER terminated

VELCADE sNDA receives FDA approval

NeoPharm submits IL13-PE38QQR IND for the treatment of IPF

DSPA submits lurasidone NDA to the FDA

FDA grants Priority Review designation for InterMune's NDA for pirfenidone

ADVENTRX Pharmaceuticals submits a NDA for its vinorelbine injectable emulsion

FDA evaluates Phase III randomized trial in acute myeloid leukemia

FDA accepts NDA review for new anticonvulsant drug

Biodel submits NDA to FDA for clearance to market VIAject

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