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FDA approves Mylan's ANDA for Venlafaxine HCl ER Capsules to treat depressive, anxiety disorder

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Venlafaxine Hydrochloride Extended-release Capsules, 37.5 mg (base), 75 mg (base) and 150 mg (base), the generic version of Wyeth's Effexor XR Capsules, which are used in the treatment of major depressive disorder and social anxiety disorder.

3 Jun 2011

Protox reports net and comprehensive loss of $2.2 million for first quarter 2011

Protox Therapeutics Inc., a leader in the development of receptor targeted therapeutic fusion proteins, today announced financial results and achievements for the quarter ended March 31, 2011.

2 Jun 2011

Repligen announces completion of RG1068 pre-New Drug Application meeting with U.S. FDA

Repligen Corporation today announced that the Company has concluded a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration related to its lead product candidate, RG1068 for improvement of magnetic resonance imaging of the pancreas.

2 Jun 2011

Teva receives FDA approval to market Eisai's Alzheimer's treatment Aricept Tablets in the U.S.

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application to market a generic version of Eisai's Alzheimer's treatment Aricept Tablets, 5 mg and 10 mg. Shipment of this product has commenced.

2 Jun 2011

Enrollment complete in BioSante's LibiGel Phase III cardiovascular and breast cancer safety study

BioSante Pharmaceuticals, Inc., today announced completion of enrollment in its ongoing LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product.

31 May 2011

Takeda, Affymax submit peginesatide NDA to FDA for treatment of anemia linked with chronic renal failure

Affymax, Inc. and Takeda Pharmaceutical Company Limited today announced the submission of a New Drug Application to the U.S. Food and Drug Administration for the investigational agent peginesatide for the treatment of anemia associated with chronic renal failure in adult patients on dialysis.

31 May 2011

Neurologix presents NLX-P101 Phase 2 trial in Parkinson's disease at 10th INS World Congress

Neurologix, Inc. announced the presentation today of efficacy results through one year of follow-up in patients treated as part of the Company's successful Phase 2 clinical trial for its novel, investigational gene therapy NLX-P101 for the treatment of Parkinson's disease.

27 May 2011

MAP Pharmaceuticals submits LEVADEX NDA to FDA for treatment of migraine in adults

MAP Pharmaceuticals, Inc. today announced that it has submitted a New Drug Application to the United States Food and Drug Administration for LEVADEX orally inhaled migraine drug for the potential acute treatment of migraine in adults.

27 May 2011

Investigators receive NIH grant to help move gene therapy for MPS IIIB toward clinical trials

Investigators at Nationwide Children's have received a grant from the National Institutes of Health to help move a therapy for MPS IIIB that has been shown effective in mice toward clinical trials in humans.

26 May 2011

Avanafil phase 3 trial in ED following radical prostatectomy meets primary endpoints

VIVUS, Inc. today announced positive results from a phase 3, placebo-controlled clinical trial of the investigational drug avanafil for the treatment of erectile dysfunction in patients following a radical prostatectomy.

25 May 2011

Azilsartan medoxomil-CLD phase 3 study results in systolic blood pressure presented at ASH 2011

Takeda Global Research & Development Center, Inc. U.S., today announced results from three phase 3 studies of the investigational fixed-dose combination of azilsartan medoxomil plus chlorthalidone.

24 May 2011

Journal of Clinical Oncology publishes Exelixis' cabozantinib phase 1 trial results in lymphoma

Exelixis, Inc. today announced the results of the phase 1 clinical trial of cabozantinib in patients with advanced solid tumors or lymphoma have been published in the current issue of the Journal of Clinical Oncology.

24 May 2011

FDA approves Taro's ANDA for Cetirizine Hydrochloride Oral Solution

Taro Pharmaceutical Industries Ltd. reported today that it has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Cetirizine Hydrochloride Oral Solution, 1 mg/mL.

24 May 2011

Phase 3 open-label study of RELISTOR presented at American Pain Society meeting

Salix Pharmaceuticals, Ltd. today announced findings from two analyses of a Phase 3 open-label study of RELISTOR (methylnaltrexone bromide) presented at the 30th Annual Scientific Meeting of the American Pain Society. The meeting is being held in Austin, TX, on May 19-21, 2011.

21 May 2011

$Positive results from Onyx's carfilzomib Phase 2b 003-A1 study in relapsed and refractory multiple myeloma$

Positive results from Onyx's carfilzomib Phase 2b 003-A1 study in relapsed and refractory multiple myeloma

Onyx Pharmaceuticals, Inc. today announced updated results from the Phase 2b 003-A1 study of single-agent carfilzomib, a next generation proteasome inhibitor, in patients with relapsed and refractory multiple myeloma. Carfilzomib achieved a clinical benefit rate (CBR) (minimal response or greater) in the study population of 37 percent with a duration of response (DOR) of 8.3 months.

20 May 2011

Pfizer seeks U.S. FDA, Japanese MHLW approval for crizotinib NDA to treat ALK-positive advanced NSCLC

Pfizer Inc. announced today that its New Drug Application for crizotinib, an oral first-in-class anaplastic lymphoma kinase inhibitor, has been accepted for filing and granted Priority Review status by the U.S. Food and Drug Administration and has been filed with the Japanese Ministry of Health, Labour and Welfare.

17 May 2011

Columbia Laboratories to be listed on NASDAQ Biotechnology Index

Columbia Laboratories, Inc. today announced the Company will be added to the NASDAQ Biotechnology Index.

17 May 2011

Perrigo's ANDA for generic Zantac 150 receives FDA final approval to treat heartburn

Perrigo Company today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for over-the-counter Ranitidine 150, a generic version of Zantac 150.

17 May 2011

Positive results from EXPAREL Phase 3 study to be presented at ASCRS Annual Scientific Meeting

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced that positive results from its Phase 3 study evaluating EXPAREL in patients following hemorrhoidectomy will be presented at the 2011 American Society of Colon and Rectal Surgeons Annual Scientific Meeting in Vancouver, British Columbia.

16 May 2011

pSivida resubmits ILUVIEN NDA to FDA for diabetic macular edema treatment

pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced that its licensee, Alimera Sciences, Inc., resubmitted a New Drug Application for the investigational drug ILUVIEN for the treatment of diabetic macular edema (DME) to the U.S. Food and Drug Administration (FDA) on May 12, 2011 to address questions raised in the Complete Response Letter (CRL) Alimera received in December 2010.

16 May 2011

New Drug Application News and Research

FDA approves Mylan's ANDA for Venlafaxine HCl ER Capsules to treat depressive, anxiety disorder

Protox reports net and comprehensive loss of $2.2 million for first quarter 2011

Repligen announces completion of RG1068 pre-New Drug Application meeting with U.S. FDA

Teva receives FDA approval to market Eisai's Alzheimer's treatment Aricept Tablets in the U.S.

Enrollment complete in BioSante's LibiGel Phase III cardiovascular and breast cancer safety study

Takeda, Affymax submit peginesatide NDA to FDA for treatment of anemia linked with chronic renal failure

Neurologix presents NLX-P101 Phase 2 trial in Parkinson's disease at 10th INS World Congress

MAP Pharmaceuticals submits LEVADEX NDA to FDA for treatment of migraine in adults

Investigators receive NIH grant to help move gene therapy for MPS IIIB toward clinical trials

Avanafil phase 3 trial in ED following radical prostatectomy meets primary endpoints

Azilsartan medoxomil-CLD phase 3 study results in systolic blood pressure presented at ASH 2011

Journal of Clinical Oncology publishes Exelixis' cabozantinib phase 1 trial results in lymphoma

FDA approves Taro's ANDA for Cetirizine Hydrochloride Oral Solution

Phase 3 open-label study of RELISTOR presented at American Pain Society meeting

Positive results from Onyx's carfilzomib Phase 2b 003-A1 study in relapsed and refractory multiple myeloma

Pfizer seeks U.S. FDA, Japanese MHLW approval for crizotinib NDA to treat ALK-positive advanced NSCLC

Columbia Laboratories to be listed on NASDAQ Biotechnology Index

Perrigo's ANDA for generic Zantac 150 receives FDA final approval to treat heartburn

Positive results from EXPAREL Phase 3 study to be presented at ASCRS Annual Scientific Meeting

pSivida resubmits ILUVIEN NDA to FDA for diabetic macular edema treatment

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