New Drug Application News and Research

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Next-generation drugs may prevent skin lesions in BRAF mutation-positive melanoma

Findings from preclinical studies in a skin cancer model showed that next-generation BRAF inhibitors used alone, or first-generation BRAF inhibitors used in combination with an epidermal growth factor receptor inhibitor, may have the potential to prevent drug-induced skin lesions in BRAF mutation-positive patients treated for melanoma.

14 Nov 2011

Watson receives FDA approval for generic Kadian ANDA

Watson Pharmaceuticals, Inc. today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for morphine sulfate extended-release capsules USP, the generic equivalent of Actavis' Kadian.

11 Nov 2011

Novartis files suit against Watson over generic Exelon

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market rivastigmine transdermal system patches, 4.6 mg/24 hr and 9.5 mg/24 hr.

11 Nov 2011

NYBC receives FDA approval for HEMACORD HPC-C cell therapy

The U.S. Food and Drug Administration today approved HEMACORD, the first licensed hematopoietic progenitor cells-cord (HPC-C) cell therapy.

10 Nov 2011

IRCM peptide chemist listed as inventor on two U.S. patents

In 2010, after more than 10 years of basic research, Dr. Peter W. Schiller, a world-renowned peptide chemist and Director of the Chemical Biology and Peptide research unit at the Institut de recherches cliniques de Montr-al (IRCM), and his international collaborators were the listed inventors on two U.S. patents awarded to the institute and covering different uses of a unique class of peptide compounds initially synthesized in Dr. Schiller's laboratory at the IRCM.

10 Nov 2011

BioSante third quarter net loss increases to $12.7 million

BioSante Pharmaceuticals, Inc. today announced financial results for the third quarter ended September 30, 2011 and provided an update on the Company's pipeline.

9 Nov 2011

Ligand third quarter total revenues decrease to $5.7 million

Ligand Pharmaceuticals Incorporated today announced financial results for the three and nine months ended September 30, 2011 and provided a business update.

9 Nov 2011

Salix third quarter total product revenue increases 81% to $146.2 million

Salix Pharmaceuticals, Ltd. today announced financial and operating results for the third quarter ended September 30, 2011 and other business updates.

9 Nov 2011

FDA accepts Genentech's vismodegib NDA for review

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has accepted and filed for review Genentech's new drug application (NDA) for vismodegib for the treatment of adults with advanced basal cell carcinoma (BCC) for whom surgery is considered inappropriate.

9 Nov 2011

QRxPharma receives FDA written acceptance for review of MoxDuo IR NDA

QRxPharma Limited announced today it received written acceptance from the United States Food and Drug Administration (FDA) for review of the MoxDuo IR New Drug Application (NDA) filed earlier this year.

9 Nov 2011

AcelRx reports revenue of $408,000 for third quarter 2011

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, reported financial results today for the third quarter and nine months ended September 30, 2011.

9 Nov 2011

QRxPharma receives date for US pain drug launch, pending approval

Australian pain-relief drug developer QRxPharma (QRX) has announced today that they have received from the US Food & Drug Adminstration.

8 Nov 2011

EpiCept reports net loss of $5.4 million for third quarter 2011

EpiCept Corporation today announced operating and financial results for the three and nine months ended September 30, 2011, and provided an update with respect to the Company's key business initiatives.

8 Nov 2011

New data from Pfizer's hematology portfolio to be presented at 53rd ASH annual meeting

Pfizer Oncology will present data on a number of investigational compounds from its hematology portfolio, including new data from bosutinib in chronic myeloid leukemia (CML), inotuzumab in non-Hodgkin lymphoma (NHL), as well as the first presentation of clinical data for PF-04449913, which inhibits Smoothened (SMO), a key component of the Hedgehog pathway.

7 Nov 2011

A.P. Pharma's third quarter net loss increases to $4.2 million

A.P. Pharma, Inc., a specialty pharmaceutical company, today reported financial results for its third quarter ended September 30, 2011 and highlighted its recent corporate progress.

7 Nov 2011

ACADIA and Meiji Seika collaborate to develop AM-831 for schizophrenia treatment

ACADIA Pharmaceuticals Inc., a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders, today announced that the U.S. Food and Drug Administration has completed its review of ACADIA's Investigational New Drug application to begin Phase I clinical studies with AM-831, an innovative small molecule for the treatment of schizophrenia.

7 Nov 2011

Sunovion reports positive results from ciclesonide nasal aerosol Phase III study for perennial allergic rhinitis

Sunovion Pharmaceuticals Inc. today announced results from a large Phase III clinical study of ciclesonide nasal aerosol, a corticosteroid formulated with a hydrofluoroalkane (HFA) propellant, intended for the treatment of allergic rhinitis.

5 Nov 2011

Vanda third quarter total revenues increase to $8.0 million

Vanda Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialization of products for central nervous system disorders, today announced financial and operational results for the third quarter and nine months ended September 30, 2011.

4 Nov 2011

FDA accepts VIVUS' Qnexa NDA for filing and review

VIVUS, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the New Drug Application (NDA) for Qnexa to treat obesity. The company resubmitted the NDA on October 17, 2011.

4 Nov 2011

Final results from Vertex KALYDECO second of two Phase 3 studies on CF

Vertex Pharmaceuticals Incorporated today announced final results from the ENVISION study, the second of two pivotal Phase 3 studies of KALYDECO, a medicine in development that targets the defective protein that causes cystic fibrosis.

4 Nov 2011