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Patient enrollment completed in vepoloxamer Phase 3 study for treatment of sickle cell disease

Mast Therapeutics, Inc., a biopharmaceutical company developing novel, clinical-stage therapies for sickle cell disease and heart failure today announced that it has completed patient enrollment in its Phase 3 clinical study of vepoloxamer for the treatment of patients with sickle cell disease experiencing vaso-occlusive crisis, known as the EPIC study.

22 Feb 2016

Mylan announces FDA's acceptance of ANDA filing for generic Advair Diskus

Mylan N.V. today announced that its abbreviated new drug application (ANDA) for fluticasone propionate 100, 250, 500 mcg and salmeterol 50 mcg inhalation powder has been accepted for filing by the U.S. Food and Drug Administration.

22 Feb 2016

CTI BioPharma announces Q4 and FY 2015 earnings

CTI BioPharma Corp. today reported financial results for the fourth quarter and full year ended December 31, 2015.

17 Feb 2016

Allergan's sNDA for TEFLARO (ceftaroline fosamil) accepted by FDA

Allergan plc today announced the U.S. Food and Drug Administration has accepted for filing the company's supplemental New Drug Application (sNDA) for TEFLARO (ceftaroline fosamil).

16 Feb 2016

Neurocrine Biosciences reports net loss of $29.3 million for fourth quarter 2015

Neurocrine Biosciences, Inc. today announced its financial results for the quarter and year ended December 31, 2015.

12 Feb 2016

Shire announces resubmission of lifitegrast NDA to FDA for treatment of dry eye disease in adults

Shire plc today announced it has resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration for its investigational candidate, lifitegrast, for the treatment of signs and symptoms of dry eye disease in adults. Shire resubmitted the NDA in response to the complete response letter (CRL) the company received from the FDA on October 16, 2015.

25 Jan 2016

FDA approves Allergan's sNDA to update label for DALVANCE (dalbavancin) for injection

Allergan plc, a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration has approved the company's supplemental new drug application (sNDA) to update the label for DALVANCE (dalbavancin) for injection.

21 Jan 2016

Mylan releases generic version of Felbatol Tablets in U.S.

Mylan N.V. today announced the U.S. launch of Felbamate Tablets USP, 400 mg and 600 mg, which is the generic version of Meda Pharms' Felbatol Tablets. Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for this product.

19 Jan 2016

Mylan announces U.S. launch of generic Ortho Tri-Cyclen Lo Tablets

Mylan N.V. today announced the U.S. launch of Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, which is the generic version of Janssen's Ortho Tri-Cyclen Lo Tablets.

5 Jan 2016

First patient enrolled in Phase 3 efficacy trial of CAM2038 for opioid dependence

Braeburn Pharmaceuticals and Camurus announce that the first patient has been randomized in the double blind Phase 3 efficacy trial of CAM2038 in opioid-dependent patients. CAM2038 medications are designed for long-acting weekly and monthly administration.

31 Dec 2015

Amarantus seeks FDA's Rare Pediatric Disease Designation and ODD to treat GCMN with Engineered Skin Substitute

Amarantus BioScience Holdings, Inc., a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, announced that it has requested Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the US Food and Drug Administration to treat GCMN with Engineered Skin Substitute (ESS).

30 Dec 2015

Mylan announces launch of Linezolid Tablets, 600 mg in U.S.

Mylan N.V. today announced the U.S. launch of Linezolid Tablets, 600 mg, which is the generic version of Pfizer's Zyvox Tablets. Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for this product, which is indicated in adults and children for the treatment of certain infections caused by susceptible Gram-positive bacteria.

29 Dec 2015

FDA approves non-alcoholic Docetaxel Injection

Teikoku Pharma USA, Inc. announced today that the U.S. Food and Drug Administration has approved Docetaxel Injection, Non-Alcohol Formula ("Docetaxel Injection") for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.

29 Dec 2015

Sanofi seeks FDA NDA approval for once-daily fixed-ratio combination of insulin glargine and lixisenatide

Sanofi announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide, which if approved would be administered as a single daily injection for the treatment of adults with type 2 diabetes.

24 Dec 2015

EMA CHMP considers AcelRx's ARX-04 for acute pain treatment for centralized review

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the intended treatment of acute pain, reported that the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has confirmed that a Marketing Authorization Application (MAA) for ARX-04 may be submitted in the European Union (EU) under the Agency's centralized procedure.

24 Dec 2015

CSL submits rIX-FP new drug application to Japan's Pharmaceuticals and Medical Devices Agency

Global biotherapeutics leader CSL Behring announced today that the company has submitted its new drug application to Japan's Pharmaceuticals and Medical Devices Agency for its investigational fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP).

22 Dec 2015

Soligenix reports positive results from SGX942 Phase 2 trial in patients with head and neck cancer

Soligenix, Inc., a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today positive results in its Phase 2 clinical trial, in which SGX942, a first-in-class Innate Defense Regulator (IDR), at a dose of 1.5 mg/kg, successfully reduced the median duration of severe oral mucositis by 50% in all patients and by 67% in patients receiving the most aggressive chemoradiation therapy (CRT) for treatment of their head and neck cancer.

16 Dec 2015

TaiGen releases Taigexyn (nemonoxacin) capsules in Taiwan

TaiGen Biotechnology Company, Limited today announced that together with its distribution partner, Holding Distribution, it has launched Taigexyn (nemonoxacin) capsules in Taiwan, the first market where Taigexyn is available.

16 Dec 2015

Kitov Pharmaceuticals' KIT-302 drug candidate meets primary efficacy endpoint in Phase III clinical trial

Kitov Pharmaceuticals, an innovative biopharmaceutical company focused on late-stage drug development, announced today that the Phase III, double-blind, placebo-controlled clinical trial for its leading drug candidate, KIT-302, successfully met the primary efficacy endpoint of the trial protocol as approved by the U.S. Food & Drug Administration (FDA).

15 Dec 2015

Egalet submits NDA for ARYMO ER (morphine sulfate) extended-release tablets

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, announced the company has submitted a new drug application (NDA) for ARYMO ER (morphine sulfate) extended-release tablets for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate.