New Drug Application News and Research

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Bristol-Myers Squibb submits New Drug Application to the U.S. Food and Drug Administration for entecavir

Bristol-Myers Squibb has announced the submission of a New Drug Application to the U.S. Food and Drug Administration for entecavir, an investigational antiviral agent under development for the treatment of chronic Hepatitis B.

4 Oct 2004

New drug application to market ramelteon for insomnia

Takeda Global Research & Development Center announced today that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) to market ramelteon (TAK-375), its investigational drug for insomnia.

26 Sep 2004

Bonviva, to treat osteoporosis, submitted for marketing authorisation in Europe

Roche and GlaxoSmithKline announced today the submission of a Marketing Authorisation Application to the European authorities for a novel, once-monthly oral formulation of their new bisphosphonate, Bonviva (ibandronate), for the treatment of postmenopausal osteoporosis.

20 Sep 2004

Tarceva plus Gemcitabine improves survival compared to Gemcitabine alone

OSI Pharmaceuticals, Inc., Genentech, Inc., and Roche announced today that results from a randomized Phase III clinical study of the investigational drug Tarceva (erlotinib HCl), in combination with gemcitabine chemotherapy met its primary endpoint of improving survival.

20 Sep 2004

Sinovac completes dosing in phase 1 human clinical testing of SARS vaccine

Sinovac Biotech Ltd. has announced that all 36 subjects of the Phase I human clinical trial for its inactivated SARS vaccine have now been vaccinated with two doses of either SARS vaccine or placebo.

7 Sep 2004

New drug application for exenatide has been accepted for review

Amylin Pharmaceuticals and Eli Lilly today announced that the New Drug Application for exenatide has been accepted for review by the Food and Drug Administration.

2 Sep 2004

MGI PHARMA acquires Aesgen for $32 million

MGI PHARMA today announced that they have signed a definitive merger agreement under which MGI PHARMA will acquire all outstanding equity of Aesgen for $32 million in cash.

1 Sep 2004

Kiwis reverse heart disease in diabetics

New Zealand biopharmaceutical company Protemix Corporation has announced the discovery of a treatment which appears to reverse heart disease in people suffering from diabetes and may lead to a more effective intervention in a major cause of death worldwide.

30 Aug 2004

No adverse side-effects have been observed in clinical trial of SARS vaccine

Sinovac Biotech has announced that all 36 subjects of the Phase I human clinical trial for its inactivated SARS vaccine have now been vaccinated with either SARS vaccine or placebo.

11 Aug 2004

CV Therapeutics initiates approval-enabling trial of drug to treat chronic angina

CV Therapeutics has announced that it has initiated an approval-enabling study of Ranexa, which, if successful, could support approval of Ranexa for the treatment of chronic angina in a restricted patient population.

3 Aug 2004

FDA approval for mint flavor nicotine gum

Watson Pharmaceuticals announced today that it has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application for nicotine polacrilex gum, mint flavor, in the 2 and 4 mg strengths.

3 Aug 2004

New Drug Application with the U.S. Food and Drug Administration for Tarceva

OSI Pharmaceuticals and Genentech have announced that OSI completed the submission of a New Drug Application with the U.S. Food and Drug Administration for Tarceva (erlotinib HCl),

3 Aug 2004

Plan B has been shown to reduce the risk of pregnancy by 89 percent

Barr Pharmaceuticals has announced that its subsidiary, Duramed Pharmaceuticals has submitted a formal response in support of its Supplemental New Drug Application (sNDA) for an Over-the-Counter (OTC) Plan B(R) emergency contraceptive product.

23 Jul 2004

Endo announces agreement With FDA for new trial design of oxymorphone extended-release tablets

Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc., today announced that it has reached agreement with the U.S. Food and Drug Administration

7 Jul 2004

New drug application for cilansetron, an investigational product for the treatment of irritable bowel syndrome

Solvay Pharmaceuticals, Inc. has submitted a New Drug Application (NDA) for cilansetron, an investigational product being studied for the treatment of irritable bowel syndrome with diarrhea predominance (IBS-D), to the FDA on June 30, 2004.

1 Jul 2004

New drug application for regulatory approval of exenatide for the treatment of type 2 diabetes

Amylin Pharmaceuticals, Inc., and Eli Lilly and Company today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for regulatory approval of exenatide.

1 Jul 2004

Alcon updates filing status of RETAANE® new drug application

Alcon, Inc. has announced that it has filed the second portion of its “rolling” New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for RETAANE® 15mg (anecortave acetate for depot suspension)

30 Jun 2004

Exelixis files new drug application for a proprietary novel anticancer compound

Exelixis, Inc. has submitted an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA) for XL999, a proprietary novel anticancer compound.

29 Jun 2004

FDA finds gepirone ER “not approvable” as a treatment for Major Depressive Disorder

The U.S. Food and Drug Administration has determined that Organon’s gepirone ER New Drug Application is “not approvable.”

25 Jun 2004

Investigational drug Abraxane is active and well tolerated in women with metastatic breast cancer

Investigational drug Abraxane™ (albumin nanoparticle paclitaxel), administered weekly without steroid premedication, is active and well tolerated in women with metastatic breast cancer whose disease had progressed while they were treated with paclitaxel (Taxol®) and/or docetaxel (Taxotere®).

15 Jun 2004