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Oramed Pharmaceuticals submits study protocol to FDA for Phase IIb trial of ORMD-0801

Oramed Pharmaceuticals submits study protocol to FDA for Phase IIb trial of ORMD-0801

Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that it has submitted the study protocol for the company's Phase IIb trial of ORMD-0801, its oral insulin capsule, to the U.S. Food and Drug Administration. [More]
FDA accepts BiondVax's IND for Multimeric-001 vaccine

FDA accepts BiondVax's IND for Multimeric-001 vaccine

BiondVax Pharmaceuticals Ltd., a clinical stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases, today announced that its Investigational New Drug Application (IND) for its Multimeric-001 vaccine (M-001), has been accepted by the US Food and Drug Administration, and the Company was notified by its regulatory advisors that the 'study may proceed'. [More]
LEO Pharma reports encouraging data from PSO-FAST clinical trial of Enstilar for psoriasis treatment

LEO Pharma reports encouraging data from PSO-FAST clinical trial of Enstilar for psoriasis treatment

LEO Pharma A/S today announced that new data being presented at the 23rd World Congress of Dermatology shows aerosol foam Enstilar® (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g), the Company's dual-action investigational aerosol foam for the treatment of psoriasis vulgaris, provided rapid itch relief and improvements in itch-related sleep loss for patients suffering from psoriasis. [More]
Sanofi announces results from Phase IIIb ELIXA study of Lyxumia in adults with diabetes and high CV risk

Sanofi announces results from Phase IIIb ELIXA study of Lyxumia in adults with diabetes and high CV risk

Sanofi announced today the presentation of full results of the Phase IIIb ELIXA study, which was designed to assess the cardiovascular (CV) safety of Lyxumia (lixisenatide) in adults with type 2 diabetes and high CV risk. [More]
Braeburn reports positive topline results from Probuphine Phase 3 study for treatment of opioid addiction

Braeburn reports positive topline results from Probuphine Phase 3 study for treatment of opioid addiction

Braeburn Pharmaceuticals, an Apple Tree Partners company, today reported positive topline results from the Phase 3 double-blind, double-dummy clinical study of Probuphine, the investigational subdermal implant containing buprenorphine HCl for the long-term maintenance treatment of opioid addiction. [More]
FDA approves Actavis ANDA for guaifenesin/pseudoephedrine tablets to relieve chest congestion

FDA approves Actavis ANDA for guaifenesin/pseudoephedrine tablets to relieve chest congestion

Actavis plc and its partner Perrigo Company plc announced today that Actavis has received U.S. Food and Drug Administration approval for its Abbreviated New Drug Application for guaifenesin/pseudoephedrine tablets and that Perrigo will begin shipments in time for the cough/cold season to its retail and wholesale customers in the U.S. The product will be packaged and marketed under store and proprietary brands and will be a high quality, value alternative to Mucinex® D tablets. [More]
Upsher-Smith announces FDA approval of sNDA for Qudexy XR extended-release capsules

Upsher-Smith announces FDA approval of sNDA for Qudexy XR extended-release capsules

Upsher-Smith Laboratories, Inc. announced that it has received U.S. Food and Drug Administration approval of a supplemental new drug application (sNDA) for Qudexy XR (topiramate) extended-release capsules for use as initial monotherapy in patients two years of age and older who are experiencing partial-onset seizures (POS) or primary generalized tonic-clonic seizures. [More]
Novartis CTL019 CAR T cell therapy demonstrates potential to treat B-cell lymphomas

Novartis CTL019 CAR T cell therapy demonstrates potential to treat B-cell lymphomas

Novartis is highlighting data from an ongoing Phase II clinical study of CTL019, an investigational chimeric antigen receptor (CAR) T cell therapy, that indicate its potential in the treatment of specific types of hard-to-treat non-Hodgkin lymphoma. [More]
Trabectedin may be better than dacarbazine for treatment of soft tissue sarcoma

Trabectedin may be better than dacarbazine for treatment of soft tissue sarcoma

Janssen Research & Development, LLC announced data from the Phase 3 multicenter study SAR3007, which demonstrated a significant improvement in progression-free survival with trabectedin (YONDELIS®) compared to dacarbazine in patients with advanced liposarcoma (LPS) or leiomyosarcoma (LMS) previously treated with an anthracycline and at least one additional chemotherapy regimen. [More]
PharmaEngine files NDA with Taiwan FDA for MM-398 to treat post-gemcitabine metastatic pancreatic cancer

PharmaEngine files NDA with Taiwan FDA for MM-398 to treat post-gemcitabine metastatic pancreatic cancer

PharmaEngine, Inc. today announced that a New Drug Application (NDA) has been submitted to the Taiwan Food and Drug Administration (TFDA) for MM-398 (irinotecan liposome injection, also known as nal-IRI) in patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. [More]
Positive results from pacritinib Phase 3 trial for treatment of myelofibrosis presented at ASCO 2015

Positive results from pacritinib Phase 3 trial for treatment of myelofibrosis presented at ASCO 2015

CTI BioPharma Corp. and Baxter International's Bioscience business today announced data from PERSIST-1 – a randomized Phase 3 registration-directed trial examining pacritinib for the treatment of myelofibrosis – in a late-breaking oral session at the 51st Annual Meeting of the American Society of Clinical Oncology, May 29-June 2, 2015 in Chicago, Ill. [More]
ESSA Pharma reports net loss of $5.9 million for second quarter 2015

ESSA Pharma reports net loss of $5.9 million for second quarter 2015

ESSA Pharma Inc. today reported financial results for the second quarter and three and six months ended March 31, 2015. Amounts, unless specified otherwise, are expressed in Canadian dollars and in accordance with International Financial Reporting Standards. [More]
Mast Therapeutics initiates Phase 3 extension study of vepoloxamer in sickle cell disease

Mast Therapeutics initiates Phase 3 extension study of vepoloxamer in sickle cell disease

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, heart failure, and arterial disease, today reported that it has initiated an open-label, multicenter Phase 3 extension study of vepoloxamer (MST-188) in sickle cell disease, referred to as "EPIC-E." [More]
FDA accepts Tris Pharma's Dyanavel XR NDA for review

FDA accepts Tris Pharma's Dyanavel XR NDA for review

Tris Pharma, Inc. announced that U.S. Food and Drug Administration has accepted for review its New Drug Application ("NDA") for Dyanavel XR (amphetamine) CII, an Extended-Release Oral Suspension. [More]
Two-drug combination improves lung function in some cystic fibrosis patients

Two-drug combination improves lung function in some cystic fibrosis patients

The combination of two drugs — an investigational drug used in conjunction with an already FDA-approved medication — improved lung function in patients with one form of cystic fibrosis, according to two new studies. [More]

Egalet announces business highlights, financial results for first quarter 2015

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative pain treatments, today reported business highlights and financial results for the three months ended March 31, 2015. [More]
Symbiomix closes $41 million Series A financing and reports positive results from SYM-1219 Phase 2 trial

Symbiomix closes $41 million Series A financing and reports positive results from SYM-1219 Phase 2 trial

Symbiomix Therapeutics today announced multiple milestones, including the closing of the third and final tranche of a $41 million Series A financing and positive results from a multi-center, randomized Phase 2 trial testing a single oral dose of SYM-1219 for the treatment of bacterial vaginosis (BV). [More]
Juniper's total revenues increase 19% to $8.3 million in first quarter 2015

Juniper's total revenues increase 19% to $8.3 million in first quarter 2015

Juniper Pharmaceuticals, Inc., today announced financial results for the three-month period ended March 31, 2015. [More]
Mylan releases generic version of Seasonale Tablets in the U.S.

Mylan releases generic version of Seasonale Tablets in the U.S.

Mylan N.V. today announced the U.S. launch of Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg, which is the generic version of Teva's Seasonale Tablets. Mylan's partner Famy Care Ltd. received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. [More]
Indivior reports top-line results from RBP-7000 phase 3 trial for treatment of schizophrenia

Indivior reports top-line results from RBP-7000 phase 3 trial for treatment of schizophrenia

Indivior PLC today announced top-line results from its phase 3 clinical trial of RBP-7000, an investigational drug in development for the treatment of schizophrenia. In this pivotal study, both doses of RBP-7000 tested, 90 mg and 120 mg administered once-monthly, met the primary endpoint with statistically and clinically significant reductions in the symptoms of acute schizophrenia over an 8-week treatment period. [More]
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