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Takeda, Lundbeck announce presentation of data from four studies that evaluate vortioxetine for MDD

Takeda, Lundbeck announce presentation of data from four studies that evaluate vortioxetine for MDD

Takeda Pharmaceutical Company Limited and H. Lundbeck A/S today announced that the companies will be presenting new data from four studies that evaluated effectiveness in treating the overall symptoms of depression in patients taking vortioxetine, an investigational agent under review with the U.S. Food and Drug Administration for the treatment of major depressive disorder. [More]
FDA to review QRxPharma's resubmitted MOXDUO NDA in July 2013

FDA to review QRxPharma's resubmitted MOXDUO NDA in July 2013

QRxPharma Limited announced today the US Food and Drug Administration has set 17 July 2013 as the date of the Advisory Committee meeting to consider the Company's resubmitted MOXDUO New Drug Application. [More]
FDA approves Arbor Pharmaceuticals' NDA for Nymalize oral solution

FDA approves Arbor Pharmaceuticals' NDA for Nymalize oral solution

Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration has approved its New Drug Application for Nymalize (nimodipine) oral solution. [More]

FDA grants priority review for Janssen's simeprevir

Medivir AB today announces that the U.S. Food and Drug Administration has granted Priority Review to the New Drug Application by Janssen for simeprevir (TMC435), an investigational NS3/4A protease inhibitor administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease. [More]

Mathematical model with prognostic factors predicts treatment effect with bevacizumab in colorectal cancer patients

Certara-, a leading provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through drug development, announced that its Pharsight Consulting Services has developed a mathematical model of tumor growth inhibition, which when combined with baseline prognostic factors, predicts treatment effect with bevacizumab for patients with metastatic colorectal cancer. [More]
POZEN announces revenue of $1.4 million for first quarter 2013

POZEN announces revenue of $1.4 million for first quarter 2013

POZEN Inc., a pharmaceutical company committed to transforming medicine that transforms lives, today announced results for the first quarter ended March 31, 2013. [More]
Biocryst reports financial results for first quarter 2013

Biocryst reports financial results for first quarter 2013

BioCryst Pharmaceuticals, Inc. today announced financial results for the first quarter ended March 31, 2013. [More]

Derma Sciences initiates patient screening in DSC127 pivotal program for treatment of diabetic foot ulcers

Derma Sciences, Inc., a medical device and pharmaceutical company focused on advanced wound care, announces that patient screening has begun in the second of two Phase 3 clinical trials with the investigational topical drug candidate DSC127 for the treatment of diabetic foot ulcers. [More]
CytRx reaches agreement with FDA for aldoxorubicin Phase 3 trial for treatment of soft tissue sarcomas

CytRx reaches agreement with FDA for aldoxorubicin Phase 3 trial for treatment of soft tissue sarcomas

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, announced today that it has reached an agreement with the U.S. Food and Drug Administration under a special protocol assessment for a global pivotal Phase 3 trial with aldoxorubicin as a treatment for patients with soft tissue sarcomas who have relapsed or were refractory following prior treatment with chemotherapy. [More]
Gilead Sciences to present results from four Phase 3 clinical trials at International Liver Congress 2013

Gilead Sciences to present results from four Phase 3 clinical trials at International Liver Congress 2013

Gilead Sciences, Inc. today announced that detailed results from four Phase 3 clinical trials (NEUTRINO, FISSION, POSITRON and FUSION) evaluating sofosbuvir, the company's investigational once-daily nucleotide NS5B inhibitor for the treatment of chronic hepatitis C virus infection, will be presented this week in oral sessions at the 48th Annual Meeting of the European Association for the Study of the Liver in Amsterdam, The Netherlands. [More]
Enrollment for Pharmacyclics' Phase III study using ibrutinib in CLL patients completed

Enrollment for Pharmacyclics' Phase III study using ibrutinib in CLL patients completed

Pharmacyclics, Inc. announced today that the enrollment target of 350 patients for its Phase III study using ibrutinib monotherapy versus ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia / small lymphocytic lymphoma, (RESONATE) was achieved on April 3, 2013. [More]

Phase 2 study of VX-661 and ivacaftor shows significant improvements in lung function among CF patients

Vertex Pharmaceuticals Incorporated today announced data from a Phase 2 study of VX-661 and ivacaftor that showed statistically significant improvements in lung function among adults with cystic fibrosis (CF) who have two copies (homozygous) of the most common mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, known as F508del. [More]
FDA's PADAC supports approval of BREO ELLIPTA as once-daily inhaled treatment for COPD

FDA's PADAC supports approval of BREO ELLIPTA as once-daily inhaled treatment for COPD

GlaxoSmithKline plc and Theravance, Inc. today announced that the Pulmonary-Allergy Drugs Advisory Committee to the US Food and Drug Administration voted that the efficacy and safety data provide substantial evidence to support approval of BREO ELLIPTA as a once-daily inhaled treatment for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (9 for, 4 against) and also for the reduction of COPD exacerbations in patients with a history of exacerbations (9 for, 4 against). [More]
FDA issues Complete Response Letter to Allergan's NDA for LEVADEX

FDA issues Complete Response Letter to Allergan's NDA for LEVADEX

Allergan, Inc. today announced that the U.S. Food and Drug Administration has issued a Complete Response Letter to its New Drug Application for LEVADEX (dihydroergotamine) inhalation aerosol for the acute treatment of migraine in adults. [More]

FDA accepts Otsuka Pharmaceutical's tolvaptan NDA for priority review

Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration has accepted for priority review the company's new drug application for the potential use of tolvaptan for the treatment of autosomal dominant polycystic kidney disease. [More]

Terumo BCT receives FDA clearance to collect platelets on Trima Accel system

Terumo BCT has received 510(k) clearance from the U.S. Food and Drug Administration to collect platelets on the Trima Accel system for storage in Isoplate platelet additive solution, which replaces a portion of the plasma in blood products. [More]

FDA approves PROLENSA for treatment of inflammation, pain after cataract surgery

Bausch + Lomb, the global eye health company, today announced that the U.S. Food and Drug Administration has approved the company's New Drug Application for PROLENSA (bromfenac ophthalmic solution) 0.07 percent prescription eye drop, an innovative once-daily nonsteroidal anti-inflammatory drug for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. [More]
Gilead Sciences submits sofosbuvir NDA to FDA for treatment of chronic HCV infection

Gilead Sciences submits sofosbuvir NDA to FDA for treatment of chronic HCV infection

Gilead Sciences today announced that the company has submitted a New Drug Application to the U.S. Food and Drug Administration for approval of sofosbuvir, a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus infection. [More]

FDA grants priority review for Bayer HealthCare's riociguat for treatment of CTEPH

Bayer HealthCare announced today that the New Drug Application for its oral investigational compound riociguat has been accepted for filing and granted priority review by the U.S. Food and Drug Administration for the treatment of inoperable chronic thromboembolic pulmonary hypertension or with persistent or recurrent CTEPH after pulmonary endarterectomy and pulmonary arterial hypertension. [More]

Tris Pharma gets FDA NDA approval for Karbinal ER Extended-release Oral Suspension

Tris Pharma, a specialty pharmaceutical company focused on developing innovative drug delivery technologies, today announced that the U.S. Food and Drug Administration has approved its New Drug Application for Karbinal ER (carbinoxamine maleate) Extended-release Oral Suspension 4mg/5ml, the first sustained-release histamine receptor blocking agent indicated for the treatment of seasonal and perennial allergic rhinitis in children ages 2 and up. [More]