MIT
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Ironwood and Forest submit of new drug application for linaclotide
Ironwood Pharmaceuticals Inc and Forest Laboratories Inc announced they have recently submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for linaclotide, a guanylate cyclase type-C (GC-C) agonist, for the treatment of…
MIT | 10 August 2011
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Affymax, Takeda submit new drug application for anemia treatment
Affymax Inc and Takeda Pharmaceutical Company Limited announced the submission of a new drug application (NDA) to the US Food and Drug Administration (FDA). This is for the investigational agent peginesatide (formerly known as Hematide) for the treat…
MIT | 01 June 2011
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Abbott submits molecular test for lung cancer therapy
Abbott announced it filed premarket approval applications to the US FDA and the Japanese Ministry of Health, Labour, and Welfare for a new molecular diagnostic test designed to detect abnormal gene rearrangements in non-small-cell lung cancer (NSCLC)…
MIT | 23 May 2011
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Sanofi commits to research and treatments for cancer patients
Sanofi announced that data from eight compounds in the company’s robust oncology portfolio will be showcased in more than 100 abstracts at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO)in Chicago, June 3-7, 2011. Dat…
MIT | 19 May 2011
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GlaxoSmithKline and XenoPort receive FDA approval for Horizant
GlaxoSmithKline and XenoPort, Inc announced that the US Food and Drug Administration (FDA) has approved Horizant (gabapentin enacarbil) extended-release tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome in adults. Horizan…
MIT | 08 April 2011
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Sanofi-aventis strengthens commitment to ophthalmology
New public private research partnership in the diagnosis, prevention and treatment of ocular diseases
MIT | 24 March 2011
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Contrave receives positive recommendation from US FDA advisory committee
The US FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 7 that the available data adequately demonstrate that the potential benefits of Orexigen and Takeda ‘s Contrave (naltrexone sustained release (SR)/bupropion SR) outweigh t…
MIT | 03 March 2011
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Bayer submits Rivaroxaban for EU marketing authorisation
Bayer has submitted an application for marketing authorization to the European Medicines Agency (EMA) for the oral anticoagulant rivaroxaban in stroke prevention in patients with atrial fibrillation (SPAF), as well as for the treatment of deep vein …
MIT | 16 February 2011
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Alzheimer's advocate climbs 7 Summits to raise awareness
Alpine mountaineer and Alzheimer's disease advocate Alan Arnette will climb the 7 Summits, the highest peak on each continent. This ambitious year-long climbing campaign – The 7 Summits Climb for Alzheimer's: Memories are Everything – aims to…
MIT | 14 January 2011
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Imaging biomarkers
Large pharma has been seeking new biomarkers for years – all part of their drug discovery process, but often only as an afterthought in the development process. That’s changed over recent years, but by-and-large the bulk of biomarker work rem…
MIT | 16 November 2010
