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FDA accepts Mundipharma EDO's Investigational New Drug Application for EDO-S101

FDA accepts Mundipharma EDO's Investigational New Drug Application for EDO-S101

Mundipharma EDO GmbH (Early Development in Oncology) is pleased to announce that the United States Food and Drug Administration has accepted the company's Investigational New Drug Application ("IND") for EDO-S101, a fusion molecule to treat relapsed/refractory haematologic malignancies and solid tumours. [More]
TWi releases generic version of MEGACE ES (megestrol acetate oral suspension) 625mg/5ml

TWi releases generic version of MEGACE ES (megestrol acetate oral suspension) 625mg/5ml

TWi Pharmaceuticals, Inc. today announced that it launched its generic version of Par Pharmaceutical's MEGACE ES (megestrol acetate oral suspension) 625mg/5ml after the United States District Court for the District of Maryland reinstated its finding that United States Patent No. 7,101,576 (the '576 Patent) is invalid. [More]
Regeneron, Sanofi to jointly advance new immuno-oncology treatment options for cancer patients

Regeneron, Sanofi to jointly advance new immuno-oncology treatment options for cancer patients

Regeneron Pharmaceuticals, Inc. and Sanofi have entered into a new global collaboration to discover, develop and commercialize new antibody cancer treatments in the emerging field of immuno-oncology. [More]
CHMP recommends Zalviso for management of acute post-operative pain in adult patients

CHMP recommends Zalviso for management of acute post-operative pain in adult patients

AcelRx Pharmaceuticals, Inc. announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency, has adopted a positive opinion for Zalviso (sufentanil sublingual tablets). [More]
Groundbreaking experimental therapy has ability to suppress ulcerative colitis

Groundbreaking experimental therapy has ability to suppress ulcerative colitis

UCLA scientists have discovered a groundbreaking experimental therapy that has the ability to suppress the development of ulcerative colitis (UC), a disease which causes inflammation in the digestive tract and colon cancer. The treatment utilizes a chemical inhibitor able to block an RNA molecule (microRNA-214) involved in the transmission of genetic information. [More]
Amgen announces submission of supplemental New Drug Application to FDA for Kyprolis (carfilzomib)

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. [More]
Melphalan granted FDA Orphan Drug Designation for treatment of cholangiocarcinoma

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. [More]
Mylan announces launch of generic Namenda Tablets in U.S.

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. [More]
Results from Phase 3 study evaluating safety and efficacy of Zalviso published in Anesthesiology

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. [More]
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]
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