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NeuroDerm starts patient enrollment in long-term safety study of ND0612 for treatment of Parkinson’s disease

NeuroDerm starts patient enrollment in long-term safety study of ND0612 for treatment of Parkinson’s disease

NeuroDerm Ltd., a clinical stage pharmaceutical company developing drugs for central nervous system disorders, today announced the start of patient enrollment in a long-term safety study (trial 012) of the company’s continuously administered subcutaneous levodopa/carbidopa formulation used in both ND0612H and ND0612L. [More]
FDA announces availability of investigational test to screen donated blood for Zika virus

FDA announces availability of investigational test to screen donated blood for Zika virus

The U.S. Food and Drug Administration today announced the availability of an investigational test to screen blood donations for Zika virus. The screening test may be used under an investigational new drug application (IND) for screening donated blood in areas with active mosquito-borne transmission of Zika virus. [More]
Breckenridge Pharmaceutical announces final FDA approval for Gabapentin Oral Solution

Breckenridge Pharmaceutical announces final FDA approval for Gabapentin Oral Solution

Breckenridge Pharmaceutical, Inc. announces the final approval by the U.S. Food and Drug Administration of the Abbreviated New Drug Application for Gabapentin Oral Solution 250 mg per 5 mL, which is AA rated to Neurontin, a drug marketed by Pfizer. [More]
Aralez resubmits NDA package for YOSPRALA to FDA

Aralez resubmits NDA package for YOSPRALA to FDA

Aralez Pharmaceuticals Inc., a global specialty pharmaceutical company, today announced that it has resubmitted to the U.S. Food and Drug Administration the New Drug Application ("NDA") for its investigational candidate, YOSPRALA (PA32540/PA8140) for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers. [More]
WRAIR researchers publish results from Plasmodium vivax malaria vaccine study

WRAIR researchers publish results from Plasmodium vivax malaria vaccine study

Walter Reed Army Institute of Research researchers recently published the results of testing a Plasmodium vivax malaria vaccine candidate in a human challenge model. [More]
Teligent obtains FDA approval for Desoximetasone Ointment USP 0.25%

Teligent obtains FDA approval for Desoximetasone Ointment USP 0.25%

Teligent, Inc., a New Jersey-based specialty generic pharmaceutical company, today announced it has received approval of the Company's abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration of Desoximetasone Ointment USP 0.25%, the generic equivalent of Topicort Ointment, 0.25%, of Taro Pharmaceuticals U.S.A., Inc. [More]
Pfizer’s IBRANCE (palbociclib) now approved for use in women with HR+, HER2- metastatic breast cancer

Pfizer’s IBRANCE (palbociclib) now approved for use in women with HR+, HER2- metastatic breast cancer

Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication expanding the use of IBRANCE (palbociclib) 125mg capsules, Pfizer’s metastatic breast cancer therapy. [More]
Astellas, Medivation announce acceptance of XTANDI sNDA for review by FDA

Astellas, Medivation announce acceptance of XTANDI sNDA for review by FDA

Astellas Pharma Inc. and Medivation, Inc. today announced that the U.S. Food and Drug Administration has accepted for review a supplemental New Drug Application (sNDA) that they have submitted for XTANDI (enzalutamide) capsules in metastatic castration-resistant prostate cancer (mCRPC), which includes findings from the Phase 2 TERRAIN and STRIVE studies, to update the relevant clinical sections within the current indication. [More]

FDA approves Lannett's ANDA for Sumatriptan Nasal Spray USP

Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application (ANDA) for Sumatriptan Nasal Spray USP, 5 mg/spray and 20 mg/spray, the therapeutic equivalent to the reference listed drug Imitrex Nasal Spray, of GlaxoSmithKline. [More]
Patient enrollment completed in vepoloxamer Phase 3 study for treatment of sickle cell disease

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. [More]
Mylan announces FDA's acceptance of ANDA filing for generic Advair Diskus

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. [More]
CTI BioPharma announces Q4 and FY 2015 earnings

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. [More]
Allergan's sNDA for TEFLARO (ceftaroline fosamil) accepted by FDA

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). [More]
Neurocrine Biosciences reports net loss of $29.3 million for fourth quarter 2015

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. [More]
Shire announces resubmission of lifitegrast NDA to FDA for treatment of dry eye disease in adults

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. [More]
FDA approves Allergan's sNDA to update label for DALVANCE (dalbavancin) for injection

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. [More]
Mylan releases generic version of Felbatol Tablets in U.S.

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

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. [More]
First patient enrolled in Phase 3 efficacy trial of CAM2038 for opioid dependence

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

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). [More]
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