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Array Biopharma reports Q4 and full year 2009 financials

Array reported revenue of $5.5 million for the fourth quarter of fiscal 2009, compared to revenue of $6.1 million for the same period in fiscal 2008. Array invested $21.3 million in proprietary research and development for the quarter to advance its seven wholly-owned drugs in clinical development and select discovery programs.

10 Aug 2009

Gtx, Inc. reports Q2 2009 results

GTx, Inc. (Nasdaq: GTXI) today reported financial results for the second quarter of 2009. The net loss for the second quarter and six months ended June 30, 2009 was $11.3 million and $22.6 million, respectively, compared with a net loss of $13.2 million and $26.0 million for the same periods in 2008. At June 30, 2009 GTx had cash, cash equivalents and short-term investments of $68.9 million.

10 Aug 2009

Bellicum Pharmaceuticals starts phase I/II trial of novel advanced prostate cancer vaccine

Bellicum Pharmaceuticals, Inc. today announced dosing of the first patient in a Phase I/II clinical trial of BP-GMAX-CD1, a novel pharmacologically regulated dendritic cell vaccine for the treatment of prostate cancer. The disease-specific trial is being conducted under a Bellicum Investigational New Drug application allowed by the FDA in 2008. The company anticipates reporting initial results of the study in 2010.

6 Aug 2009

Innexus Biotechnology announces business development initiative on lead preclinical candidate

InNexus Biotechnology Inc. announced today that the Company will embark on a business development initiative for DXL625™ (CD20), the Company’s lead preclinical candidate for the prospective treatment of Non-Hodgkin’s Lymphoma and/or Chronic Lymphocytic Leukemia.

6 Aug 2009

Orexo: Abstral NDA submitted to U.S. FDA

Orexo AB has announced that its partner, UK-based international specialty pharmaceutical company ProStrakan Group plc, has submitted the New Drug Application (NDA) for Abstral™ (for the treatment of breakthrough cancer pain in opioid-tolerant patients) to the US Food and Drug Administration (FDA).

6 Aug 2009

Impax Labs receives FDA approval for generic version of Depakote

Impax Laboratories has confirmed that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company’s Abbreviated New Drug Application (ANDA) for generic version of Depakote® (divalproex ER) 500mg Extended-release Tablets.

5 Aug 2009

Epicept files NDA for Ceplene in Canada

EpiCept Corporation has announced that it has filed a New Drug Submission (NDS) with Health Canada for Ceplene® (histamine dihydrochloride) for the treatment of acute myeloid leukemia (AML) patients in first complete remission. Health Canada typically accepts or refuses an NDS and designates review status within forty-five days of filing. If accepted, the customary timeframe for completion of review and an approval decision is within one year.

5 Aug 2009

US FDA approves Lipsovir for cold sores

The US Food and Drug Administration (FDA) has now approved Lipsovir, i.e. granted Medivir's New Drug Application (NDA) for the use of acyclovir and hydrocortisone for early treatment of recurrent cold sores to decreases the risk of cold sores, and to shorten the healing time for those cold sores which are not prevented.

3 Aug 2009

Tarceva shown to extend survival in advanced non-small cell lung cancer when used after initial chemo

OSI Pharmaceuticals, Inc. has announced further results from the Phase III SATURN study showing that Tarceva® (erlotinib) extended the survival of patients with advanced non-small cell lung cancer (NSCLC) when used as single agent, maintenance therapy in patients who did not progress following first-line treatment with platinum-based chemotherapy.

2 Aug 2009

Study of pulmonary hypertension treatment in sickle cell patients stopped by NHLBI

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has stopped a clinical trial testing a drug treatment for pulmonary hypertension in adults with sickle cell disease nearly one year early due to safety concerns.

28 Jul 2009

Mylan receives FDA approval for additional strengths of antipsychotic Haloperidol

Mylan Inc. has announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (ANDA) for Haloperidol Tablets USP, 10 mg and 20 mg. These strengths are in addition to Mylan's currently marketed 0.5 mg, 1 mg, 2 mg and 5 mg strengths of the product.

20 Jul 2009

Mylan receives FDA approval for generic version of thyroid deficiency treatment Cytomel

Mylan Inc. has announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Liothyronine Sodium Tablets USP, 5 mcg (base), 25 mcg (base) and 50 mcg (base).

16 Jul 2009

Watson confirms new drug application for generic Sanctura XR

Watson Pharmaceuticals, Inc. has confirmed that its subsidiary, Watson Laboratories, Inc.-Florida, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its trospium chloride extended-release 60 mg capsules prior to the expiration of a patent owned by Supernus Pharmaceuticals, Inc.

15 Jul 2009

NDA for Exenatide once weekly accepted for FDA review

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the New Drug Application (NDA) for exenatide once weekly has been accepted for review by the U.S. Food and Drug Administration (FDA).

7 Jul 2009

Shire files treatment protocol for Velaglucerase Alfa for Gaucher’s disease

Shire plc has announced that, at the request of the FDA, in view of a potential restriction on the availability of the current approved and marketed treatment for Gaucher’s disease patients, it has filed a treatment protocol for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Gaucher’s disease.

7 Jul 2009

Lilly resubmits Cymbalta supplemental NDA for chronic pain to FDA

Eli Lilly and Company has resubmitted its supplemental New Drug Application (sNDA) for Cymbalta (duloxetine HCl) for the management of chronic pain to the U.S. Food and Drug Administration (FDA).

3 Jun 2009

Schering-Plough announces European filing of Sycrest (asenapine) for schizophrenia and bipolar I disorder

Schering-Plough Corporation has announced that the European Medicines Agency (EMEA) has validated (accepted for review) the company's Marketing Authorization Application (MAA) for Sycrest (asenapine) sublingual tablets for the treatment of schizophrenia and manic episodes associated with bipolar I disorder. The application will follow the Centralized Procedure.

2 Jun 2009

A.P. Pharma submits NDA for APF530 in chemo-induced nausea and vomiting

A.P. Pharma, Inc. has announced that it has submitted a New Drug Application (NDA) for its lead product, APF530, to the U.S. Food and Drug Administration (FDA). APF530 is being developed for the prevention of chemotherapy-induced nausea and vomiting (CINV) and is a long-acting formulation of granisetron that utilizes the Company's proprietary Biochronomer drug delivery system.

18 May 2009

Pirfenidone shows promise for idiopathic pulmonary fibrosis

A large, well-controlled, multi-national clinical trial program has demonstrated the effectiveness and safety of what may become the first FDA-approved medicine for idiopathic pulmonary fibrosis, or IPF.

17 May 2009

FDA accepts Pharmaxis’ Aridol NDA for review

Pharmaxis has announced it had received notification from the United States Food and Drug Administration (FDA) that the New Drug Application (NDA) for its mannitol bronchial challenge test Aridol has been accepted for standard review. The FDA will advise the result of the review on 27 December 2009.

13 May 2009

New Drug Application News and Research

Array Biopharma reports Q4 and full year 2009 financials

Gtx, Inc. reports Q2 2009 results

Bellicum Pharmaceuticals starts phase I/II trial of novel advanced prostate cancer vaccine

Innexus Biotechnology announces business development initiative on lead preclinical candidate

Orexo: Abstral NDA submitted to U.S. FDA

Impax Labs receives FDA approval for generic version of Depakote

Epicept files NDA for Ceplene in Canada

US FDA approves Lipsovir for cold sores

Tarceva shown to extend survival in advanced non-small cell lung cancer when used after initial chemo

Study of pulmonary hypertension treatment in sickle cell patients stopped by NHLBI

Mylan receives FDA approval for additional strengths of antipsychotic Haloperidol

Mylan receives FDA approval for generic version of thyroid deficiency treatment Cytomel

Watson confirms new drug application for generic Sanctura XR

NDA for Exenatide once weekly accepted for FDA review

Shire files treatment protocol for Velaglucerase Alfa for Gaucher’s disease

Lilly resubmits Cymbalta supplemental NDA for chronic pain to FDA

Schering-Plough announces European filing of Sycrest (asenapine) for schizophrenia and bipolar I disorder

A.P. Pharma submits NDA for APF530 in chemo-induced nausea and vomiting

Pirfenidone shows promise for idiopathic pulmonary fibrosis

FDA accepts Pharmaxis’ Aridol NDA for review

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