Nycomed announces FDA filing for Daxas® in COPD
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- Category: Nycomed
Nycomed has announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Daxas® as a once-daily oral treatment for patients with symptomatic COPD. The NDA submission is based on encouraging results from four Phase III trials of Daxas® (roflumilast) in the treatment of symptomatic COPD.
Novartis delivers strong operational performance in the first half of 2009
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- Category: Novartis
- Pharmaceuticals an industry growth leader: Net sales up 12% (local currencies) in first half of 2009 on contributions from new products and expansion in all regions
- R&D maintains momentum: Anti-cancer therapy Afinitor introduced in the US, awaiting EU approval; new biologic Ilaris and OTC brand Prevacid 24HR gain US approvals; clinical trials set to start in July for A(H1N1) pandemic flu vaccine
- H1 2009 operating results advance well, but impacted negatively by currencies:
Pfizer Receives Approval From European Commission For Pending Acquisition Of Wyeth
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- Category: Pfizer
Pfizer Inc (NYSE: PFE) today announced that the European Commission (EC) has approved under the European Union (EU) Merger Regulation the company's pending acquisition of Wyeth. The Commission's decision includes Pfizer's commitment to divest certain animal health assets in the EU.
Pfizer Announces New Phase 1 Data From Two Novel Compounds For Alzheimer's Disease
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- Category: Pfizer
Pfizer Inc has announced results from two Phase 1 safety studies, one of PF-04360365, a humanized anti-amyloid monoclonal antibody (mAb), and another of dimebon (latrepirdine*) in combination with donepezil HCl tablets, in patients with Alzheimer's disease.(1,2) Based on the Phase 1 study results, PF-04360365 has advanced into Phase 2.(3)
GSK announces new commitments to fight HIV/AIDS in Sub-Saharan Africa
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- Category: GlaxoSmithKline
Andrew Witty, Chief Executive Officer of GlaxoSmithKline, has announced a series of new initiatives targeted at improving research, development, and access to HIV/AIDS medicines for children in Sub-Saharan Africa and supporting healthcare for people living with HIV and AIDS.
Abbott and GSK to Collaborate on Molecular Diagnostic Test
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- Category: Abbott
Abbott has entered into an agreement with GlaxoSmithKline (GSK) to develop an automated molecular diagnostic test, based on polymerase chain reaction (PCR) technology, intended to screen non-small cell lung cancer (NSCLC) tumors for expression of the MAGE-A3 antigen. GSK's MAGE-A3 ASCI (Antigen Specific Cancer Immunotherapy) candidate is currently being evaluated as an adjuvant treatment in resected NSCLC in the Phase III clinical study MAGRIT, the largest lung cancer treatment study ever conducted.
Daiichi Sankyo and Lilly Receive U.S. FDA Approval for Effientâ¢
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- Category: Daiichi Sankyo
Daiichi Sankyo, Inc. and Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) approved Effient™(prasugrel) tablets for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndromes who are managed with an artery-opening procedure known as percutaneous coronary intervention (PCI).
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