Lundbeck initiates clinical phase II trials with Lu AE58054
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- Category: Lundbeck
H. Lundbeck A/S announced the initiation of a multi-centre, placebo-controlled, fixed-dose study of Lu AE58054 as add-on to donepezil in patients with moderate Alzheimer's disease. The clinical phase II study is planned to enrol approximately 270 patients.
FDA Grants IBsolvMIR Orphan Drug designation in the treatment of diabetes patients in the U.S.
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- Category: Product
TikoMed AB, a biotechnology company focused on development and commercialization of innovative treatments for immune diseases and cell therapies, today announced that IBsolvMIR® has been granted orphan drug designation for the prevention of graft rejection of pancreatic islet transplantation by the U.S. Food and Drug Administration (FDA).
Novartis inaugurates large-scale US based cell-culture influenza vaccine manufacturing facility
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- Category: Novartis
Today, Novartis officially inaugurated the US's first ever large-scale flu cell culture vaccine and adjuvant manufacturing facility in Holly Springs, North Carolina. The facility is a result of a partnership between Novartis and the US Department of Health and Human Services (HHS).
Merck KGaA to Expand Research and Development Presence in China
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- Category: Merck Group
Merck KGaA announced plans to strengthen its global research and development (R&D) capabilities of its Merck Serono division by establishing a global R&D center in Beijing, China. Merck is planning to invest more than € 150 million and create more than 200 new qualified jobs over the next four years to set up the China R&D center and conduct R&D activities in China.
Merck Receives CHMP Positive Opinion for New Fertility Treatment, ELONVA®
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- Category: Merck
Merck & Co., Inc. announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended approval of ELONVA® (corifollitropin alfa injection) as a treatment in controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (ART) program.
FDA Advisory Committee Finds Data Support SPIRIVA® HandiHaler®
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- Category: Pfizer
The U.S. Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee voted 11 to 1 that clinical data included in a supplemental new drug application (sNDA) provide substantial and convincing evidence to support the claim that SPIRIVA® HandiHaler® (tiotropium bromide inhalation powder) reduces exacerbations (worsening of symptoms) in patients with chronic obstructive pulmonary disease (COPD).
AstraZeneca Submits US New Drug Application for Brilinta (Ticagrelor)
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- Category: AstraZeneca
AstraZeneca today announced it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS). The proposed trade name for ticagrelor is BRILINTA, pending approval from the FDA.
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