New Drug Application News and Research

RSS

Enrollment complete in NeurogesX NGX-1998 Phase 2 clinical study for postherpetic neuralgia

NeurogesX, Inc., a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced the completion of patient enrollment in its Phase 2 clinical study of NGX-1998, a topical liquid formulation of high-concentration capsaicin, in patients with postherpetic neuralgia (PHN).

16 Jun 2011

Meda presents new positive results from Dymista Phase-III trial on AR at EAACI 2011

Meda presents new positive results from a Phase-III clinical trial of Dymista at the annual meeting of the European Academy of Allergy and Clinical Immunology (EAACI) in Istanbul, Turkey.

15 Jun 2011

Pfizer, pSivida partner to develop latanoprost implant for ocular hypertension and glaucoma

Drug delivery company pSivida Corp today announced it amended and restated its Research and Development Agreement with Pfizer Inc. to focus solely on the development of a long-term, sustained-release implant to deliver latanoprost for patients with ocular hypertension and glaucoma.

15 Jun 2011

FDA extends Pacira's EXPAREL PDUFA goal date by three months

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) for EXPAREL by three months.

14 Jun 2011

CTI completes pixantrone NDA resubmission meeting with FDA's Division of Oncology Drug Products

Cell Therapeutics, Inc. today announced that it met with the U.S. Food and Drug Administration's Division of Oncology Drug Products.

14 Jun 2011

Cypress receives FDA approval for ZUTRIPRO, REZIRA NDA to treat cough and common cold

Cypress Pharmaceutical announced today that the Food and Drug Administration (FDA) approved a new drug application (NDA) for ZUTRIPRO Oral Solution (CIII) and REZIRA Oral Solution.

14 Jun 2011

Incyte announces additional results from ruxolitinib Phase III trial on myelofibrosis

Incyte Corporation announced today additional symptom improvement and quality of life (QoL) results from COMFORT-I, a randomized, double-blinded, placebo-controlled Phase III trial of Incyte's JAK1 and JAK2 inhibitor, ruxolitinib, in patients with myelofibrosis (MF).

13 Jun 2011

Repligen total revenue increases 30% to $27,291,000 for fiscal year 2011

Repligen Corporation today reported results for the fourth quarter and fiscal year 2011, ended March 31, 2011.

9 Jun 2011

Neurologix reports new results from NLX-P101 Phase 2 trial against Parkinson's disease

Neurologix, Inc. announced today several new results from the Company's successful Phase 2 clinical trial for its novel, investigational gene therapy NLX-P101 for the treatment of Parkinson's disease (PD) as part of a comprehensive presentation of study findings to the National Institutes of Health (NIH) Recombinant DNA Advisory Committee.

9 Jun 2011

Top-line results from Cipher's CIP-ISOTRETINOIN Phase III study against severe nodular acne

Cipher Pharmaceuticals Inc. today provided top-line safety and efficacy results from the Phase III safety study of CIP-ISOTRETINOIN, the Company's novel, patented formulation of isotretinoin for the treatment of severe, nodular acne.

8 Jun 2011

FDA approves Mylan's ANDA for Donepezil HCl Tablets to treat dementia linked with Alzheimer's

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Donepezil Hydrochloride (HCl) Tablets, 5 mg and 10 mg, the generic version of Eisai's Aricept Tablets, which are used to treat dementia associated with Alzheimer's disease.

8 Jun 2011

FDA accepts Topaz's ivermectin NDA for treatment for head lice infestations

Topaz Pharmaceuticals Inc., a privately held specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for the use of ivermectin topical cream as a treatment for head lice infestations in children and adults.

7 Jun 2011

AMPYRA ER Tablets improve walking ability in patients with multiple sclerosis

Acorda Therapeutics, Inc. today announced an analysis of pooled clinical trial results showed patients who were responders to AMPYRA (dalfampridine) Extended Release Tablets, 10 mg demonstrated clinically relevant improvements in walking ability as measured by patient self-report on the 12-Item Multiple Sclerosis Walking Scale (MSWS-12), regardless of either their baseline Expanded Disability Status Scale (EDSS) score or baseline walking speed.

7 Jun 2011

Ridaforolimus Phase III SUCCEED clinical trial on metastatic sarcoma meets primary endpoint

Merck, known outside the United States and Canada as MSD, and ARIAD Pharmaceuticals, Inc.,, today announced the presentation of detailed results from the Phase III SUCCEED clinical trial. SUCCEED evaluated oral ridaforolimus, an investigational mTOR inhibitor, in patients with metastatic soft-tissue or bone sarcomas who previously had a favorable response to chemotherapy.

7 Jun 2011

FDA issues revised PDUFA date for Lannett's Morphine Sulfate Oral Solution NDA

Lannett Company, Inc. announced today that the U.S. Food and Drug Administration (FDA) has issued a revised Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2011 for the company's 505(b)(2) New Drug Application for Morphine Sulfate Oral Solution

7 Jun 2011

Incyte seeks FDA marketing approval of ruxolitinib for myelofibrosis

Incyte Corporation announced today that it has submitted a New Drug Application (NDA) for its lead investigational compound, ruxolitinib (INCB18424), to the US Food and Drug Administration (FDA).

6 Jun 2011

FDA accepts Sunovion ciclesonide HFA nasal aerosol NDA for review

Sunovion Pharmaceuticals Inc. today announced that the New Drug Application (NDA) submitted for ciclesonide nasal aerosol in a hydrofluoroalkane (HFA) formulation has been accepted by the U.S. Food and Drug Administration.

6 Jun 2011

Patent infringement suit filed against Impax Laboratories in connection with Detrol

Impax Laboratories, Inc. today confirms that Pfizer Inc., Pharmacia & Upjohn Company LLC and Pfizer Health AB have filed suit for patent infringement against Impax in the United States District Court for the District of New Jersey in connection with Detrol (tolterodine tartrate) immediate-release, 1 mg and 2 mg tablets.

4 Jun 2011

Medical oncologists confirm benefits of crizotinib in ALK positive lung cancer

A drug that targets a specific type of lung cancer shows a dramatic response in more than half of the people who take it. The drug, called crizotinib, has been in clinical trials since 2006, and the results from the largest group of patients to take it within the first of these clinical trials are being presented at the annual meeting of the American Society of Clinical Oncology.

4 Jun 2011

Orexigen meets FDA to gain clarity on approval for Contrave NDA to treat obesity

Orexigen Therapeutics, Inc. announced today that it recently met with the Food and Drug Administration (FDA) regarding the New Drug Application for Contrave (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss.

3 Jun 2011

New Drug Application News and Research

Enrollment complete in NeurogesX NGX-1998 Phase 2 clinical study for postherpetic neuralgia

Meda presents new positive results from Dymista Phase-III trial on AR at EAACI 2011

Pfizer, pSivida partner to develop latanoprost implant for ocular hypertension and glaucoma

FDA extends Pacira's EXPAREL PDUFA goal date by three months

CTI completes pixantrone NDA resubmission meeting with FDA's Division of Oncology Drug Products

Cypress receives FDA approval for ZUTRIPRO, REZIRA NDA to treat cough and common cold

Incyte announces additional results from ruxolitinib Phase III trial on myelofibrosis

Repligen total revenue increases 30% to $27,291,000 for fiscal year 2011

Neurologix reports new results from NLX-P101 Phase 2 trial against Parkinson's disease

Top-line results from Cipher's CIP-ISOTRETINOIN Phase III study against severe nodular acne

FDA approves Mylan's ANDA for Donepezil HCl Tablets to treat dementia linked with Alzheimer's

FDA accepts Topaz's ivermectin NDA for treatment for head lice infestations

AMPYRA ER Tablets improve walking ability in patients with multiple sclerosis

Ridaforolimus Phase III SUCCEED clinical trial on metastatic sarcoma meets primary endpoint

FDA issues revised PDUFA date for Lannett's Morphine Sulfate Oral Solution NDA

Incyte seeks FDA marketing approval of ruxolitinib for myelofibrosis

FDA accepts Sunovion ciclesonide HFA nasal aerosol NDA for review

Patent infringement suit filed against Impax Laboratories in connection with Detrol

Medical oncologists confirm benefits of crizotinib in ALK positive lung cancer

Orexigen meets FDA to gain clarity on approval for Contrave NDA to treat obesity

Advancing Intracellular Delivery with LumiPore®

How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

The role of UV-Vis in biopharma QC

Latest News