ACORDA THERAPEUTICS, INC.: Announces FDA Acceptance of New Drug Application for INBRIJA™ (levodopa inhalation powder)

Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for INBRIJA. INBRIJA is an investigational inhaled levodopa treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen Read More »

ALLERGAN USA INC.: FDA Acceptance of Medicines360's Filing for supplemental New Drug Application for LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg

Allergan plc, (NYSE: AGN) a leading global pharmaceutical company, and Medicines360, a global nonprofit women's health pharmaceutical company with a mission of expanding access to quality medicines, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Medicines360's supplemental New Drug Application (sNDA). Read More »

PFIZER: Announces Update on European Marketing Authorization Application for SUTENT® (sunitinib) in Adult Patients at High Risk of Recurrent Renal Cell Carcinoma

Pfizer Inc. (NYSE:PFE) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended against expanding use of SUTENT® (sunitinib) to include the adjuvant treatment of adult patients at a high risk of recurrent renal cell carcinoma (RCC) following nephrectomy (surgical removal of the cancerous kidney). Read More »

MCKESSON SPECIALTY HEALTH: ERLEADA (Apalutamide), the First FDA-Approved Treatment for Non-Metastatic, Castration-Resistant Prostate Cancer, Available for Order at Biologics, Inc.

Biologics, Inc., a McKesson Specialty Health oncology and complex care pharmacy services company, has been selected by the Janssen Pharmaceutical Companies of Johnson & Johnson1 to be in the limited distribution network for ERLEADA™ (apalutamide), the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer (NM-CRPC). The addition of this critical patient therapy brings the total number of oncology and supportive therapies accessible through Biologics to 115. Read More »

ONCONOVA THERAPEUTICS: Announces License Agreement with Pint Pharma to Commercialize Rigosertib for Treatment of Myelodysplastic Syndromes in Latin America

Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), announced that they have entered into a license agreement with Pint Pharma GmbH to commercialize rigosertib, a novel and targeted anti-cancer compound currently in a Phase 3 study for the treatment of MDS, a group of rare hematologic malignancies. Pint Pharma is a European-based pharmaceutical company focused on the development, registration and commercialization of specialty-based treatments for the Latin American market. Read More »

FERRING PHARMACEUTICALS: Enteris BioPharma Initiates Feasibility Program with Ferring Pharmaceuticals to Develop an Oral Formulation of a Peptide

Enteris BioPharma, Inc., a biotechnology company developing innovative drug products built around its proprietary delivery technologies, announced that it has entered into a feasibility development agreement with Ferring Pharmaceuticals to utilize Enteris' proprietary oral delivery platform, Peptelligence®, to develop an oral formulation of a peptide-based injectable therapeutic from Ferring. Read More »