New Drug Application News and Research

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Sun Pharma receives FDA approval for generic Tiazac ANDA

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of once-a-day Tiazac® extended release capsules.

18 Nov 2010

FDA approves Sun Pharma's generic Clarinex ANDA

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted it an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Schering Plough's Clarinex® tablets, 5 mg.

18 Nov 2010

FDA grants three years of marketing exclusivity to ISTA's BROMDAY

ISTA Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has granted the Company three years of marketing exclusivity for BROMDAY (bromfenac ophthalmic solution) 0.09%, as provided under the Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman Act.

18 Nov 2010

VX-770 drug candidate improves lung function in people with cystic fibrosis

In a study published in this week's New England Journal of Medicine, treatment with a new drug candidate known as VX-770 resulted in improvements in lung function and markers of disease in a Phase 2 clinical trial of 39 people with cystic fibrosis (CF). There were no discontinuations due to adverse events in the study, and the frequency of adverse events was similar across the study groups.

18 Nov 2010

New investigational drug improves lung function in CF patients

An investigational drug targeting a defective protein that causes cystic fibrosis has been shown to improve lung function in a small study of CF patients, according to findings published Nov. 18, 2010, in the New England Journal of Medicine.

17 Nov 2010

Progenics initiates ONO-3849 phase 2 clinical trial for OIC in Japan

Progenics Pharmaceuticals, Inc. today announced the initiation of a phase 2 clinical trial of subcutaneous methylnaltrexone in Japan by its collaborator, Ono Pharmaceutical Co., Ltd. The drug, designated ONO-3849 in Japan, is being evaluated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness such as cancer.

17 Nov 2010

FDA grants Impax final approval for generic Allegra-D ANDA

Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for the generic version of Allegra-D® (Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release) 60mg/120mg tablets. The Company is preparing for product launch through Global Pharmaceuticals, Impax's generic division.

16 Nov 2010

Clinical Data receives U.S. patent for vilazodone

Clinical Data, Inc. today announced the issuance of U.S. Patent No. 7,834,020 claiming the polymorphic form of vilazodone (vilazodone HCl, Form IV), a compound currently in development for the treatment of Major Depressive Disorder.

16 Nov 2010

Merrion prepares Phase III study for Orazol in breast cancer treatment

After recent consultation with the FDA in November 2010, Merrion is preparing for its Phase III study for Orazol. If successful, the Phase III study will allow a new drug application for Orazol to be made under the FDA's abbreviated approval procedure section 505(b)(2) using a single Phase III study. The study will compare Orazol against placebo as an adjuvant breast cancer treatment with a primary endpoint of Disease Free Survival of patients with breast cancer.

16 Nov 2010

A.P. Pharma third quarter net loss increases to $1.7 million

A.P. Pharma, Inc., a specialty pharmaceutical company, today reported financial results for its third quarter ended September 30, 2010.

15 Nov 2010

Biodel reports data on Linjeta formulation for type 1 diabetes at Technology Meeting in Bethesda

Scientists from Biodel Inc. reported new findings from the company's Linjeta, insulin glargine, "smart" basal insulin and stabilized glucagon development programs in poster presentations yesterday and today at the Tenth Annual Diabetes Technology Meeting in Bethesda, MD.

15 Nov 2010

Labopharm receives notice about Activis' ANDA for OLEPTRO

Labopharm Inc. today announced that on November 11, 2010 it received notice from Actavis South Atlantic LLC advising that Actavis has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for approval to market 150 and 300 mg generic versions of OLEPTRO (trazodone hydrochloride extended-release 150 and 300 mg tablets) in the United States.

15 Nov 2010

Neurologix third quarter net loss decreases to $2.3 million

Neurologix, Inc., a biotechnology company developing innovative gene therapies for the brain and central nervous system ("CNS"), today reported its financial results for the three and nine months ended September 30, 2010.

12 Nov 2010

Labopharm receives notice of Activis' ANDA submission for generic OLEPTRO

Labopharm Inc. today announced that on November 11, 2010 it received notice from Actavis South Atlantic LLC advising that Actavis has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for approval to market 150 and 300 mg generic versions of OLEPTRO™ (trazodone hydrochloride extended-release 150 and 300 mg tablets) in the United States.

12 Nov 2010

Vertex to enroll additional treatment arm in telaprevir/VX-222 Phase 2 clinical trial for HCV

Vertex Pharmaceuticals Incorporated today announced plans to enroll an additional treatment arm as part of its ongoing Phase 2 clinical trial evaluating 12-week regimens of Vertex's lead investigational hepatitis C virus (HCV) protease inhibitor, telaprevir, in combination with its lead investigational HCV polymerase inhibitor, VX-222.

10 Nov 2010

TONIX Pharmaceuticals announces Phase 2a study results of cyclobenzaprine in Fibromyalgia Syndrome

TONIX Pharmaceuticals (formerly known as Krele Pharmaceuticals), a specialty central nervous system (CNS) pharmaceutical company, announced results of a new analysis of a Phase 2a study, which previously demonstrated reduced pain, fatigue and tenderness in patients with Fibromyalgia Syndrome (FMS) following bedtime administration of very low dosage (VLD) cyclobenzaprine (CBP).

10 Nov 2010

Enrollment complete in Nabi's second NicVAX Phase III clinical trial for nicotine addiction

Nabi Biopharmaceuticals announced today that it has completed enrollment in the second Phase III clinical trial of NicVAX® (Nicotine Conjugate Vaccine), the company's innovative and proprietary investigational candidate vaccine being developed to treat nicotine addiction and prevent smoking relapse.

10 Nov 2010

Arena and Eisai report positive results from lorcaserin BLOOM-DM trial in obese, overweight diabetics

Arena Pharmaceuticals, Inc. and Eisai Inc. reported today that top-line results from the one-year lorcaserin BLOOM-DM trial demonstrate statistically significant weight loss in obese and overweight patients with type 2 diabetes. In this trial, lorcaserin met all three co-primary efficacy endpoints. In addition, as described below, lorcaserin patients taking lorcaserin 10 mg twice daily (BID) achieved statistically significant improvements in multiple secondary endpoints, including HbA1c, as compared to patients randomized to placebo.

9 Nov 2010

Arena third quarter net loss increases to $36.3 million

Arena Pharmaceuticals, Inc. today reported financial results for the third quarter ended September 30, 2010. Arena also reported earlier today top-line results from its lorcaserin Phase 3 BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) trial.

9 Nov 2010

EpiCept third quarter net loss decreases to $3.2 million

EpiCept Corporation today announced operating and financial results for the three and nine months ended September 30, 2010, and provided an update with respect to the Company's key business initiatives.

9 Nov 2010