Eisai gets BTD for Lenvatinib

Eisai gets BTD for Lenvatinib

WOODCLIFF LAKE, N.J., July 28, 2015 /PRNewswire/ -- Eisai Inc. announced today the U.S. Food and Drug Administration (FDA) granted lenvatinib, the company's multiple receptor tyrosine kinase inhibitor, Breakthrough Therapy designation for the investigational use in patients with advanced or metastatic renal cell carcinoma (RCC) who were previously treated with a vascular endothelial growth factor (VEGF)-targeted therapy. RCC is the most common …

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Progenics gets Breakthrough Therapy Designation for Azedra

Progenics gets Breakthrough Therapy Designation for Azedra

TARRYTOWN, N.Y., July 28, 2015 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative ways to target and treat cancer, announced today that the U.S. Food and Drug Administration (FDA) has designated Azedra as a Breakthrough Therapy for the treatment of patients with iobenguane-avid metastatic or recurrent pheochromocytoma and paraganglioma. Azedra is currently being evaluated in a …

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EMA accepts marketing application for Grazoprevir

EMA accepts marketing application for Grazoprevir

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the European Medicines Agency (EMA) has accepted for review a marketing authorization application (MAA) for grazoprevir/elbasvir (100mg/50mg), an investigational, once-daily, single-tablet combination therapy for the treatment of adult patients with chronic hepatitis C (HCV) genotypes (GT) 1, 3, 4 or 6 infection.1 The EMA will initiate …

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BMS gets BTD for BMS-663068

BMS gets BTD for BMS-663068

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company(NYSE:BMY) today announced that the U.S. Food and Drug Administration(FDA) has granted Breakthrough Therapy Designation to the investigational compound BMS-663068 when used in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients. BMS-663068 is an oral prodrug of the molecule BMS-626529 and first-in-class HIV-1 attachment inhibitor. The attachment inhibitor …

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Ibrutinib approved in EU for WM

Ibrutinib approved in EU for WM

Today AbbVie (NYSE:  ABBV) announced the European Commission (EC) granted marketing authorization for IMBRUVICA® (ibrutinib) as the first treatment option available in all 28 member states of the European Union (EU) for the treatment of Waldenstrom's macroglobulinemia (WM), a rare, slow growing blood cancer, in adult patients who have received at least one prior therapy, or in first line treatment for patients unsuitable …

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DBV h1 2015

DBV h1 2015

BAGNEUX, France, July 27, 2015 (GLOBE NEWSWIRE) -- DBV Technologies, (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market:DBVT), a clinical-stage specialty biopharmaceutical company, announced today its interim financial results for the first half of 2015. The full interim financial report (regulated information) is available on DBV's website in the Investor Relations section. The 2015 half-year financial statements were subject …

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Sprint Bioscience enters into collaboration with Bayer HealthCare on tumor metabolism program

Sprint Bioscience enters into collaboration with Bayer HealthCare on tumor metabolism program

Sprint Bioscience AB (publ) (Sprint Bioscience) and Bayer HealthCare (Bayer) have entered into a collaboration and license agreement for the research, development, and commercialization of oncological drug candidates. Under the agreement, Sprint Bioscience licenses an early-stage inhibitor program targeting tumor metabolism to Bayer. Subsequently, Bayer will have full control over further development and worldwide commercialization rights for potential cancer therapeutics and diagnostics. …

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GSK’s Synflorix™ receives CHMP positive opinion for major label extension

GSK’s Synflorix™ receives CHMP positive opinion for major label extension

GSK’s Synflorix™ receives CHMP positive opinion for major label extension GSK today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the expansion of the SynflorixTM European label. The updated label now includes effectiveness data for protection against invasive pneumococcal disease (IPD) and pneumonia and acute otitis …

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Catalyst files Firdapse

Catalyst files Firdapse

CORAL GABLES, Fla., July 22, 2015 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced the initiation of a rolling submission of a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for Firdapse® for the treatment of Lambert-Eaton …

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Latest in drugs

Dorgenmeltucel-L

Dorgenmeltucel-L is an investigational HyperAcute™ for melanoma. The product consists of melanoma cell lines that have been genetically modified to express alpha-gal carbohydrates on cell surface molecules. Upon injection into the patient, the alpha-gal stimulates an immune response against melanoma-specific antigens in the tumor cell lines. The patient's immune system then targets their own melanoma cells, destroying them. A phase 2 study of dorgenmeltucel-L …

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Tergenpumatucel-L

Tergenpumatucel-L is an investigational HyperAcute™ for non-small cell lung cancer (NSCLC). The product consists of 3 NSCLC cell lines that have been genetically modified to express alpha-gal carbohydrates on cell surface molecules. Upon injection into the patient, the alpha-gal stimulates a rapid and powerful immune response against NSCLC-specific antigens in the tumor cell lines. The patient’s immune system then targets their own NSCLC …

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Azedra

Azedra is a radio-therapeutic with FDA Fast Track status currently being studied in a phase 2 registrational trial under a SPA with the FDA using a surrogate marker as registrational endpoint. In addition to potentially treating pheochromocytoma and paraganglioma, Azedra may also have utility in treating neuroblastoma and other neuroendocrine tumors. Clinical trials for Azedra have not been completed and regulatory approvals for …

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Lenvatinib

Lenvatinib (E7080) Lenvatinib,  discovered and developed by Eisai, is an oral molecular targeted agent that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors (VEGFR1 (FLT1), VEGFR2 (KDR) and VEGFR3 (FLT4)), in addition to other proangiogenic and oncogenic pathway-related RTKs (including fibroblast growth factor (FGF) receptors FGFR1, 2, 3 and 4; the platelet-derived growth factor (PDGF) receptor …

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Synflorix

Synflorix is indicated for active immunisation against IPD, such as meningitis and sepsis, in infants and children from 6 weeks up to 5 years of age. In a number of countries, Synflorix has additional indications, including community-acquired pneumonia (CAP), acute otitis media (AOM) caused by Streptococcus pneumoniae (S. pneumoniae), and AOM caused by non-typable Haemophilus influenzae (NTHi). Synflorix is licensed in …

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