New Drug Application News and Research

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Amgen announces submission of supplemental New Drug Application to FDA for Kyprolis (carfilzomib)

Amgen today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for Kyprolis (carfilzomib) for Injection to seek an expanded indication for the treatment of patients with a form of blood cancer, relapsed multiple myeloma, who have received at least one prior therapy.

23 Jul 2015

Melphalan granted FDA Orphan Drug Designation for treatment of cholangiocarcinoma

Delcath Systems, Inc., a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, announced today that the U.S. Food and Drug Administration Office of Orphan Products Development has granted Orphan Drug Designation for melphalan for the treatment of cholangiocarcinoma.

20 Jul 2015

Mylan announces launch of generic Namenda Tablets in U.S.

Mylan N.V. today announced the U.S. launch of Memantine Hydrochloride Tablets USP, 5 mg and 10 mg, which is the generic version of Forest's Namenda Tablets.

14 Jul 2015

Results from Phase 3 study evaluating safety and efficacy of Zalviso published in Anesthesiology

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that results from the IAP311 study have been published in Anesthesiology.

2 Jul 2015

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.

30 Jun 2015

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'.

17 Jun 2015

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.

10 Jun 2015

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.

8 Jun 2015

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.

8 Jun 2015

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.

2 Jun 2015

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.

2 Jun 2015

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.

2 Jun 2015

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.

2 Jun 2015

Combination of cobimetinib and vemurafenib can halt progression of metastatic melanoma for one year

Data from the pivotal coBRIM Phase III study, presented by Lead Investigator Dr James Larkin today at the American Society of Clinical Oncology (ASCO) annual meeting, demonstrate that Roche’s investigational MEK inhibitor cobimetinib, used in combination with BRAF inhibitor vemurafenib, typically offers people with previously untreated advanced metastatic melanoma (BRAFV600 mutation-positive unresectable or metastatic) one full year (median 12.3 months) without their disease worsening.

2 Jun 2015

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.

1 Jun 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.

30 May 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.

29 May 2015

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."

26 May 2015

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.

21 May 2015

Johns Hopkins researchers identify new therapy to treat lung cancer

A multidisciplinary team led by Johns Hopkins researcher Venu Raman, Ph.D., with notable contributions from Guus Bol, Farhad Vesuna and Phuoc Tran of Johns Hopkins, has identified a new therapy for lung cancer, the most common cancer worldwide. The therapy has been in development for six years and involves a first-in-class molecule designed by the team.

20 May 2015

New Drug Application News and Research

Amgen announces submission of supplemental New Drug Application to FDA for Kyprolis (carfilzomib)

Melphalan granted FDA Orphan Drug Designation for treatment of cholangiocarcinoma

Mylan announces launch of generic Namenda Tablets in U.S.

Results from Phase 3 study evaluating safety and efficacy of Zalviso published in Anesthesiology

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

FDA accepts BiondVax's IND for Multimeric-001 vaccine

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

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

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

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

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

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

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

Combination of cobimetinib and vemurafenib can halt progression of metastatic melanoma for one year

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

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

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

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

FDA accepts Tris Pharma's Dyanavel XR NDA for review

Johns Hopkins researchers identify new therapy to treat lung cancer

Drug Discovery - Second Edition eBook

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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