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Baxter submits BAX 855 NDA to Japan's MHLW for treatment of hemophilia A patients

Baxter submits BAX 855 NDA to Japan's MHLW for treatment of hemophilia A patients

Nektar Therapeutics reported today that partner Baxter International Inc. announced that the company has submitted a new drug application (NDA) to Japan's Ministry of Health, Labour and Welfare for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment based on ADVATE [Antihemophilic Factor (Recombinant)] for patients over 12 years of age with hemophilia A. [More]
Japanese MHLW grants priority review for AbbVie's investigational hepatitis C treatment

Japanese MHLW grants priority review for AbbVie's investigational hepatitis C treatment

AbbVie today announced that the Japanese Ministry of Health, Labour and Welfare has granted priority review for its investigational, two direct-acting antiviral treatment of ombitasvir/paritaprevir/ritonavir. [More]
Aeterna Zentaris plans to conduct Macrilen Phase 3 clinical study for AGHD

Aeterna Zentaris plans to conduct Macrilen Phase 3 clinical study for AGHD

Aeterna Zentaris Inc. today announced plans to conduct a new, confirmatory Phase 3 clinical study to demonstrate the efficacy of Macrilen (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone deficiency ("AGHD"), as well as a dedicated thorough QT study to evaluate the effect of Macrilen on myocardial repolarization. [More]
Eisai, Arena complete two Phase 1 registrational trials for once-daily formulation of lorcaserin

Eisai, Arena complete two Phase 1 registrational trials for once-daily formulation of lorcaserin

Eisai Inc. and Arena Pharmaceuticals, Inc. today announced the completion of two Phase 1 registrational clinical trials that Eisai and Arena believe demonstrate bioequivalence of an investigational once-daily extended release formulation of lorcaserin, as compared to the twice-daily immediate release formulation approved by the US Food and Drug Administration and marketed as BELVIQ. [More]
Mylan announces the U.S. launch of first generic version of Generess Fe tablets

Mylan announces the U.S. launch of first generic version of Generess Fe tablets

Mylan N.V. today announced the U.S. launch of Norethindrone and Ethinyl Estradiol Tablets (Chewable) 0.8 mg/0.025 mg and Ferrous Fumarate Tablets, 75 mg (Chewable), which is the generic version of Warner Chilcott's Generess Fe Tablets. [More]
Personalized cancer vaccines can be used to marshal powerful immune response

Personalized cancer vaccines can be used to marshal powerful immune response

Personalized melanoma vaccines can be used to marshal a powerful immune response against unique mutations in patients' tumors, according to early data in a first-in-people clinical trial at Washington University School of Medicine in St. Louis. [More]
Actavis seeks FDA marketing approval for Ambrisentan Tablets, 5 mg and 10 mg

Actavis seeks FDA marketing approval for Ambrisentan Tablets, 5 mg and 10 mg

Actavis plc today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market Ambrisentan Tablets, 5 mg and 10 mg. [More]
Columbia Laboratories to adopt Juniper Pharmaceuticals brand marks

Columbia Laboratories to adopt Juniper Pharmaceuticals brand marks

Columbia Laboratories, Inc., today announced that it will adopt Juniper Pharmaceuticals, Inc. as its new corporate brand. The name change will become effective Friday, April 10, 2015, and the Company's common stock will begin trading on the Nasdaq Stock Exchange under the new ticker symbol — "JNP" — on Monday, April 13, 2015. [More]
Mylan announces U.S. launch of Amlodipine and Valsartan Tablets

Mylan announces U.S. launch of Amlodipine and Valsartan Tablets

Mylan N.V. today announced the U.S. launch of Amlodipine and Valsartan Tablets, 5 mg/160 mg, 5 mg/320 mg, 10 mg/160 mg, 10 mg/320 mg, which is the generic version of Novartis' Exforge Tablets. [More]
Amgen receives FDA priority review designation for Kyprolis to treat relapsed multiple myeloma

Amgen receives FDA priority review designation for Kyprolis to treat relapsed multiple myeloma

Amgen today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) of Kyprolis® (carfilzomib) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. [More]
LEO Pharma A/S announces regulatory submission of  ENSTILAR® for psoriasis in Europe

LEO Pharma A/S announces regulatory submission of ENSTILAR® for psoriasis in Europe

ENSTILAR® has the potential to be the first cutaneous foam approved for the treatment of psoriasis vulgaris. [More]
TPU's submission of Docetaxel Injection Concentrate, Non-Alcohol Formula NDA acknowledged by FDA

TPU's submission of Docetaxel Injection Concentrate, Non-Alcohol Formula NDA acknowledged by FDA

Teikoku Pharma USA announced today that it has submitted a 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration for Docetaxel Injection Concentrate, Non-Alcohol Formula on February 26, 2015 and received an acknowledgment of the receipt from FDA. [More]
Mast plans to develop vepoloxamer for chronic heart failure treatment

Mast plans to develop vepoloxamer for chronic heart failure treatment

Mast Therapeutics, Inc., a clinical-stage biopharmaceutical company leveraging its molecular adhesion and sealant technology (MAST) platform to develop novel therapies for sickle cell disease, arterial disease and heart failure, today announced its plans to develop vepoloxamer (MST-188) for the treatment of patients with chronic heart failure. [More]
Amgen seeks marketing approval of Repatha (evolocumab) in Japan for treatment of high cholesterol

Amgen seeks marketing approval of Repatha (evolocumab) in Japan for treatment of high cholesterol

Amgen today announced that an application seeking marketing approval of Repatha (evolocumab) for the treatment of high cholesterol has been submitted for review to the Ministry of Health, Labour and Welfare in Japan. [More]

Columbia Laboratories' revenues increase 11% to $32.5 million in 2014

Columbia Laboratories, Inc., today announced financial results for the three- and twelve-month periods ended December 31, 2014. [More]
Mylan releases Fentanyl Transdermal System 37.5, 62.5 and 87.5 mcg/hr in U.S.

Mylan releases Fentanyl Transdermal System 37.5, 62.5 and 87.5 mcg/hr in U.S.

Mylan N.V. and Mylan Inc. today announced the U.S. launch of its Fentanyl Transdermal System 37.5, 62.5 and 87.5 mcg/hr, adding to its existing offering of Fentanyl Transdermal System 12, 25, 50, 75 and 100 mcg/hr. [More]
United Therapeutics announces FDA approval of dinutuximab for treatment of high-risk neuroblastoma

United Therapeutics announces FDA approval of dinutuximab for treatment of high-risk neuroblastoma

United Therapeutics Corporation announced today that the United States Food and Drug Administration has approved Unituxin (dinutuximab) Injection (formerly called ch14.18), in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. [More]
Pacritinib for myelofibrosis meets primary endpoint in Phase 3 PERSIST-1 trial

Pacritinib for myelofibrosis meets primary endpoint in Phase 3 PERSIST-1 trial

CTI BioPharma Corp. and Baxter International Inc. today announced positive top-line results for the primary endpoint from PERSIST-1, the randomized, controlled Phase 3 registration clinical trial examining pacritinib, a next generation oral JAK2/FLT3 multikinase inhibitor, for the treatment of patients with primary or secondary myelofibrosis. [More]
FDA approves Astellas' CRESEMBA for treatment of invasive aspergillosis, invasive mucormycosis

FDA approves Astellas' CRESEMBA for treatment of invasive aspergillosis, invasive mucormycosis

Astellas today announced that the U.S. Food and Drug Administration has approved its New Drug Application (NDA) for the use of CRESEMBA (isavuconazonium sulfate), the prodrug for isavuconazole, for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis). [More]
ANI acquires approved ANDA for Flecainide Acetate tablets USP

ANI acquires approved ANDA for Flecainide Acetate tablets USP

ANI Pharmaceuticals, Inc. today announced that it has acquired the approved abbreviated new drug application ("ANDA") for Flecainide Acetate tablets USP 50mg, 100mg and 150mg, previously marketed by Teva Pharmaceuticals. [More]
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