U.S. FDA Provides Response to Perampanel New Drug Application
WOODCLIFF LAKE, N.J.–(BUSINESS WIRE)–Eisai Inc. announced today that the FDA has issued a Refusal to File letter in response to the company’s NDA for perampanel, an investigational drug, for the treatment of partial-onset seizures.
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U.S. FDA Provides Response to Perampanel New Drug Application
VICTRELIS™ (boceprevir), First-in-Class Oral Hepatitis C Virus Protease Inhibitor, Approved in the European Union for Treatment of Chronic Hepatitis…
WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission (EC) has approved VICTRELISTM (boceprevir) for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Chronic hepatitis C virus (HCV) is a potentially serious vira
Forest Laboratories, Inc. and Pierre Fabre Medicament Announce Positive Phase III Results with Levomilnacipran in Patients with Major Depressive…
NEW YORK & PARIS–(BUSINESS WIRE)–Forest Laboratories, Inc. (NYSE: FRX) and Pierre Fabre Medicament today announced preliminary top-line results from a Phase III study of levomilnacipran for the treatment of adults with major depressive disorder (MDD). Analyses of the data indicate a statistically significant improvement was achieved for levomilnacipran treated patients for all dose groups compared to placebo on the primary efficacy endpoint which was change from baseline to end of week 8 in th
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Forest Laboratories, Inc. and Pierre Fabre Medicament Announce Positive Phase III Results with Levomilnacipran in Patients with Major Depressive…
Nuvilex Announces Successful Breast Cancer Preclinical Studies
SCOTTSDALE, Ariz.–(BUSINESS WIRE)–Nuvilex, Inc. (OTCQB: NVLX) announced today successful results for the treatment of breast cancer from preclinical studies. In recently completed work using the Nuvilex live-cell encapsulation technology and a combination of two anticancer drugs, clear positive results of elimination of breast tumors were achieved in preclinical models. The encapsulated cells used in this study were specifically designed to express at high levels both the normal human cytochro
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Nuvilex Announces Successful Breast Cancer Preclinical Studies
Positive Top-Line Results For Pfizer’s Lyrica In Phase 3 Study Of Patients With Fibromyalgia In Japan
TOKYO & NEW YORK–(BUSINESS WIRE)–Pfizer Japan announced today the top-line results for Lyrica (pregabalin) Study A0081208 – Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate Efficacy and Safety of Pregabalin (CI-1008) in the Treatment of Fibromyalgia. The results demonstrated a statistically significant reduction in the endpoint mean pain score, the primary efficacy analysis in the study, with pregabalin compared to placebo. Further analyses will be conducted on these
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Positive Top-Line Results For Pfizer’s Lyrica In Phase 3 Study Of Patients With Fibromyalgia In Japan
Forest and Almirall Announce Submission of New Drug Application for Aclidinium Bromide for the Treatment of Chronic Obstructive Pulmonary Disease…
NEW YORK & BARCELONA, Spain–(BUSINESS WIRE)–Forest Laboratories, Inc. (NYSE: FRX) and Almirall, S.A. (ALM.MC) announced they have recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for aclidinium bromide, a long-acting inhaled antimuscarinic agent developed for the treatment of COPD. The submission includes efficacy data from a large Phase III double-blind placebo-controlled program in which patients received aclidinium bromide 400 mcg or 200 mcg twi
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Forest and Almirall Announce Submission of New Drug Application for Aclidinium Bromide for the Treatment of Chronic Obstructive Pulmonary Disease…
Garamycin® Ophthalmic Solution Now Available from Fera Pharmaceuticals
NEW YORK–(BUSINESS WIRE)–Fera Pharmaceuticals announced the launch today of Garamycin (gentamicin sulfate) Ophthalmic Solution USP. Garamycin Ophthalmic Solution, a broad spectrum anti-infective, is indicated for the treatment of ocular bacterial infections such as conjunctivitis, keratitis and blepharitis. Garamycin is a trusted brand name and the product is a favorite among physicians who are looking for a single ingredient anti-infective ophthalmic solution. About Fera Pharmaceuticals, LLC
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Garamycin® Ophthalmic Solution Now Available from Fera Pharmaceuticals
FDA Grants Accelerated Approval of ISTODAX® As Treatment for Patients with Peripheral T-Cell Lymphoma Who Have Received at Least One Prior Therapy
SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (Nasdaq:CELG) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for its Supplemental New Drug Application (sNDA) for an additional indication for ISTODAX (romidepsin) for injection for the treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy. ISTODAX is also approved for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have receive
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FDA Grants Accelerated Approval of ISTODAX® As Treatment for Patients with Peripheral T-Cell Lymphoma Who Have Received at Least One Prior Therapy
Enzon Announces Discontinuation of PEG-SN38 Program in Metastatic Colorectal Carcinoma in Light of Evolving Standards of Care
PISCATAWAY, N.J.–(BUSINESS WIRE)–Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced that, in light of evolving standards of care for the treatment of metastatic colorectal cancer (mCRC), the Company will discontinue its PEG-SN38 (EZN-2208) clinical program in this disease, following conclusion of its Phase II study. Enzon continues to enroll studies for the Company’s other PEG-SN38 programs, which include a soon-to-be fully enrolled Phase II study in metastatic breast cancer, a Phase I
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Enzon Announces Discontinuation of PEG-SN38 Program in Metastatic Colorectal Carcinoma in Light of Evolving Standards of Care
FDA Approves Merck’s VICTRELIS™ (boceprevir), First-in-Class Oral Hepatitis C Virus (HCV) Protease Inhibitor
WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK) (known as MSD outside the United States and Canada) announced today that the U.S. Food and Drug Administration (FDA) has approved VICTRELIS™ (boceprevir), the company’s innovative new medicine for the treatment of chronic hepatitis C (CHC). VICTRELIS is approved for the treatment of CHC genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease
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FDA Approves Merck’s VICTRELIS™ (boceprevir), First-in-Class Oral Hepatitis C Virus (HCV) Protease Inhibitor
