WASHINGTON (MedPage Today) — The FDA has formally approved the enzyme replacement therapy velaglucerase alfa (VPRIV) — already okayed for pre-approval marketing — for pediatric and adult patients with Gaucher disease.
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Absorption Systems, a leader in testing drugs for ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity), has joined the Society of Toxicology, the premier global professional association of toxicologists, as an SOT Affiliate. The firm, a contract research organization, has more than a decade of experience assisting pharmaceutical and biotechnology companies in determining which compounds in [...]
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In recognition of World Rare Disease Day, the U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced a more streamlined process to help regulators better identify and share information throughout the development process of orphan drug and biologic products, which are developed specifically to treat rare medical conditions. Both agencies have [...]
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VION PHARMACEUTICALS, INC. (OTC Bulletin Board: VIONQ) announced that it had received a response from the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (”SPA”) for its oncology therapeutic Onrigin™ (laromustine) Injection…
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Supelco, a division of Sigma-Aldrich® (Nasdaq: SIAL), announced the launch of Ascentis Express Peptide ES-C18, a high-speed, high-performance liquid chromatography (HPLC) column based on a new 160 angstrom Fused-Core™ particle design…
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Pfizer Inc (NYSE:PFE) announced that the United States Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) has recommended the use of Prevnar 13™ (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) for healthy children aged 2 months through 59 months for the prevention of invasive pneumococcal disease…
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Forest Laboratories, Inc. (NYSE: FRX) announced that the U.S. Food and Drug Administration (FDA) did not approve the additional indication for Bystolic(R) (nebivolol) tablets as a treatment for stable chronic heart failure (CHF) as requested in the company’s Supplemental New Drug Application (sNDA). Bystolic is currently approved in the US for the treatment of [...]
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Gilead Sciences, Inc. (Nasdaq:GILD) announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Cayston(R)(aztreonam for inhalation solution) as a treatment to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P. aeruginosa)…
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Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that a phase III study showed the combination of Avastin (bevacizumab) and chemotherapy followed by maintenance use of Avastin increased the time women with advanced ovarian cancer lived without their disease worsening (progression-free survival or PFS) compared to chemotherapy alone…
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Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for VPRIV, a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of Type 1 Gaucher disease in pediatric and adult patients…
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