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Approval for Temodar (temozolomide) capsules for newly diagnosed glioblastoma multiforme

Schering-Plough today reported that the U.S. Food and Drug Administration (FDA) has granted approval for Temodar (temozolomide) Capsules for use in combination with radiotherapy for the treatment of adult patients with newly diagnosed glioblastoma multiforme (GBM), a form of malignant brain cancer.

16 Mar 2005

FDA has accepts new drug application for Exubera (inhaled human insulin powder)

Dr. John Patton, co-founder and chief scientific officer for Nektar reported that Pfizer and The Sanofi-Aventis Group have announced that the FDA has accepted for filing a new drug application for Exubera (inhaled human insulin powder).

3 Mar 2005

Experimental drug Revlimid showing promise as treatment for myelodysplastic syndrome (MDS)

Alan List, M.D., leader of the Hematologic Malignancies Program at the H. Lee Moffitt Cancer Center & Research Institute, recently conducted a phase I/II trial of the experimental drug Revlimid showing promise as an innovative way to treat patients with myelodysplastic syndrome (MDS), a form of pre-leukemia.

10 Feb 2005

Launch date announced for Abraxane to treat metastatic breast cancer

American Pharmaceutical Partners announced today that February 8, 2005 is the launch date of Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound). Abraxane will be marketed by the national sales force of Abraxis Oncology, APP's proprietary sales and marketing division.

25 Jan 2005

FDA knocks back anticancer drug Marqibo

Inex Pharmaceuticals announced today that United States Food and Drug Administration (FDA) provided an action letter detailing that the anticancer drug Marqibo (vincristine sulfate liposomes injection) is "not approvable" under the FDA's accelerated approval regulations based on the phase 2 clinical trial data submitted.

19 Jan 2005

Velcade (bortezomib) phase III clinical trial initiated in patients with newly diagnosed multiple myeloma

Millennium Pharmaceuticals today announced, in collaboration with Johnson & Johnson Pharmaceutical Research & Development, LLC, the initiation of VISTA (Velcadeas Initial Standard Therapy in multiple myeloma: Assessment with melphalan and prednisone), a multicenter, international phase III clinical trial of Velcadein combination with melphalan and prednisone versus melphalan and prednisone in patients with newly diagnosed multiple myeloma (MM) who are not transplant candidates.

10 Jan 2005

FDA clearance to test influenza vaccine, Fluviral

ID Biomedical Corporation announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to begin immediate clinical testing of its influenza vaccine, Fluviral, in the United States under an Investigational New Drug application (IND).

7 Jan 2005

Information submitted via new drug applications could easily be made accessible to the public

A researcher at Oregon Health & Science University and the Portland Veterans Affairs Medical Center is calling upon the U.S. Food and Drug Administration (FDA) to share more information provided by pharmaceutical companies regarding their clinical drug trials.

28 Dec 2004

FDA accepts Genmab's Investigational New Drug Application for active rheumatoid arthritis treatment

Genmab announced today the US Food and Drug Administration (FDA) accepted its Investigational New Drug Application (IND) to start a Phase I/II dose escalation trial for HuMax-CD20 to treat patients with active rheumatoid arthritis (RA) who have failed one treatment with one or more disease modifying anti-rheumatic drugs (DMARDs).

13 Dec 2004

FDA approves Topigen's investigational New Drug Application for new inhalation drug to treat asthma

Phase 1 clinical trial can be initiated for ASM8, a new inhalation drug that is designed to treat asthma through a unique approach by attacking multiple mediators of the inflammatory mechanism rather than the single mediator approach of current therapies.

8 Dec 2004

HHS purchases 1.2 million doses of GSK's Fluarix flu vaccine

HHS Secretary Tommy G. Thompson has announced that the Food and Drug Administration authorized the use of GlaxoSmithKline influenza vaccine, Fluarix, in the United States under an Investigational New Drug application.

8 Dec 2004

Pfizer submits regulatory filings for Revatio (sildenafil citrate) as a treatment for pulmonary arterial hypertension

Sildenafil is the active ingredient in Viagra, Pfizer's erectile dysfunction medication used by more than 23 million men worldwide.

4 Dec 2004

FDA approves Remodulin for the treatment of pulmonary arterial hypertension

United Therapeutics Corporation announced today that the U.S. Food and Drug Administration (FDA) has issued an approval letter for the intravenous use of Remodulin based on data establishing its bioequivalence with the previously approved subcutaneous administration of Remodulin.

24 Nov 2004

BiDil demonstrates significant improvement in survival rates in African American heart failure patients

"African Americans suffer disproportionately from heart failure and until A-HeFT have been underrepresented in heart failure trials," said Malcolm Taylor, M.D., Chair of the Association of Black Cardiologists Committee on Heart Failure. "A-HeFT represents a significant step forward in addressing these disparities."

9 Nov 2004

Wyeth shows new Phase III data about its investigational antibiotic, tigecycline

Wyeth Pharmaceuticals recently presented exciting new Phase III data about its investigational antibiotic, tigecycline, based on a clinical trial in patients with complicated intra-abdominal infections (cIAI).

4 Nov 2004

Maxim Pharmaceuticals to withdraw NDA for advanced malignant melanoma

Maxim Pharmaceuticals has announced that based upon the negative outcome of it's confirmatory Phase 3 clinical trial (M0104) studying Ceplene(TM) (histamine dihydrochloride) in combination with Interleukin-2 (IL-2) in advanced malignant melanoma patients with liver metastases, it plans to close the treatment protocol approved by the FDA earlier this year.

2 Nov 2004

Tentative approval of testosterone gel product

Par Pharmaceutical Companies today announced that its partner, Paddock Laboratories, has been granted tentative approval by the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for testosterone gel 1%.

1 Nov 2004

New Drug Application for Velac accepted for filing by the FDA

Connetics Corporation, a specialty pharmaceutical company focused on dermatology, today announced that the U.S. Food and Drug Administration has accepted for filing the Company's New Drug Application for Velac

25 Oct 2004

Boehringer Ingelheim - New Drug Application (NDA) for tipranavir

The Company is seeking accelerated approval of tipranavir and has requested a priority, six-month review of the NDA. Priority review designation is based upon whether a drug provides a significant improvement in the treatment of a serious or life-threatening disease.