New Drug Application News and Research

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FDA grants priority review for Revlimid

Celgene Corporation announced that the U.S. Food and Drug Administration (FDA) has granted a Priority Review designation to its Supplemental New Drug Application (sNDA) for REVLIMID (lenalidomide) for the treatment of relapsed or refractory multiple myeloma.

6 Mar 2006

Bristol-Myers Squibb agrees to record securities litigation settlement with sweeping drug disclosure requirements announces Labaton Sucharow

After prosecuting the securities litigation claims against Bristol-Myers Squibb Co. (BMS) for over five years, Labaton Sucharow, Lead Counsel representing the class and Lead Plaintiff, the LongView Collective Investment Fund of the Amalgamated Bank, reached an agreement in principle to settle the claims for $185 million in addition to meaningful corporate governance reforms that will affect future consumers and investors alike.

23 Jan 2006

Mylan announces tentative approval for Rabeprazole sodium delayed-release tablets

Mylan Laboratories Inc. has announced that the U.S. Food and Drug Administration has granted tentative approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Application for Rabeprazole Sodium Delayed-release Tablets, 20 mg.

23 Jan 2006

Chiron initiates Phase I/II study of an investigational cell culture-derived influenza vaccine

Cell culture-derived influenza vaccine (commonly referred to as "flu cell culture" vaccine) represents the next generation of influenza vaccine, both for annual vaccine production and for long-term pandemic preparedness.

26 Oct 2005

CytRx granted "Fast Track" designation for ALS drug

CytRx Corporation today announced that the U.S. Food and Drug Administration (FDA) has granted "Fast Track" designation for the company's leading drug candidate arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease).

26 Sep 2005

Potential new way to fight HIV

Researchers have confirmed for the first time the benefit of an innate defense system present in the few patients who remain healthy after years of infection with HIV despite receiving no treatment, according to an article published in the September edition of the Journal of Virology.

1 Sep 2005

FDA approval sought for Pfizer's new cancer drug

Drug company Pfizer has announced it has submitted a New Drug Application (NDA) for its cancer drug Sutent, to the U.S. Food and Drug Administration (FDA).

11 Aug 2005

Genelabs drug discovery team advances compounds against the hepatitis C virus

Genelabs Technologies today announced that a non-nucleoside compound from its internal Hepatitis C virus (HCV) drug discovery program has advanced into preclinical development.

4 Aug 2005

Takeda Pharmaceuticals submits NDA for a new oral diabetes medication

Takeda Pharmaceuticals North America today announced that the company has submitted a New Drug Application (NDA) for a new oral medication that combines pioglitazone HCl and glimepiride, a sulfonylurea, to the United States Food and Drug Administration (FDA) for the treatment of type 2 diabetes.

30 Jun 2005

New cardiovascular drug derived from Dan Shen (Saliva miltiorrhiza)

Through a large number of clinical trials over the past 3 years, researchers from the CAS Shanghai Institute of Materia Medica (SIMM) have developed a new cardiovascular drug with a definite effective component extracted from Dan Shen (Saliva miltiorrhiza), a medicinal herb widely used in China.

21 Jun 2005

FDA approves treatment for diarrhea caused by Cryptosporidium infection

The U.S. Food and Drug Administration (FDA) has approved Alinia (nitazoxanide) tablets and oral suspension for treating diarrhea caused by Cryptosporidium parvum infection in adults and children 12 years and older. The product, already approved to treat the same infection in younger children, received a priority review by FDA.

19 Jun 2005

AstraZeneca announces U.S. labeling change to Iressa (gefitinib tablets)

AstraZeneca has announced that after discussions with the U.S. Food and Drug Administration (FDA), the company is making a labeling change to Iressa (gefitinib tablets).

19 Jun 2005

New diabetes drug has a double whammy and is a potential blockbuster

There are, according to the latest statistics, more than 18 million Americans with diabetes, and each year over a million new cases are diagnosed.

13 Jun 2005

Targepeutics issued new U.S patent

Targepeutics has announced the issuance of U.S. Patent No. 6,884,603 for its genetically modified, mutated Interleukin 13 (IL-13) technology platform for the treatment of malignant glioma, a brain tumor (17,500 people annually; $200 million annual market).

31 May 2005

New drug for the treatment of premature ejaculation has great results

In new data published this week it has been shown that men taking dapoxetine hydrochloride for the treatment of premature ejaculation (PE) have experienced significant improvements in sexual function, including ejaculatory control, satisfaction with sexual intercourse for men and their partners, and increases in intravaginal ejaculatory latency time (IELT).

24 May 2005

FDA recommends approval of the investigational anti-HIV drug tipranavir

Boehringer Ingelheim today announced that the U.S. Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee recommended the approval of the investigational anti-HIV drug tipranavir (11-3). Tipranavir is a non-peptidic protease inhibitor that requires boosting with low-dose ritonavir and must be used in combination with other antiretroviral agents.

20 May 2005

Benitec announces clinical candidate for the treatment of Hepatitis C

Benitec Ltd. announced today that it has identified a highly promising clinical candidate for its RNA interference (RNAi)-based therapeutic against the hepatitis C virus (HCV).

10 May 2005

Fast Track designation for Terlipressin in type 1 hepatorenal syndrome

Protein Design Labs, Inc. and privately held Orphan Therapeutics, LLC today reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track status to the development of terlipressin for the treatment of patients with type 1 hepatorenal syndrome (HRS).

20 Apr 2005

Cyclosporine inhalation solution (CyIS) significantly improves long-term survival in lung-transplant patients

Data presented for the first time at the 25th Annual Meeting and Scientific Session of the International Society for Heart and Lung Transplantation (ISHLT) show that cyclosporine inhalation solution (CyIS) significantly improves long-term survival in lung-transplant patients compared to placebo.

10 Apr 2005

US tendency to arrogantly flout international ethical practice for patient trials abroad

The US Food and Drug Administration (FDA) has proposed that observing a widely accepted code of medical ethics that protects patients who take part in trials is not necessary for studies conducted abroad, states a comment in this week’s issue of The Lancet.

28 Mar 2005