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May 2, 2012
MS Boon: Many Drugs On The Way, But Will Payors Swallow The Cost?
Two new oral drugs for relapsing remitting multiple sclerosis are poised for a near-term launch, and more drugs that work through different mechanisms of action could soon follow.
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April 18, 2012
Spotlight On: EMA accepts submission for first biosimilar antibody product
The European Medicines Agency has published its list of new product applications, among which is a submission for biosimilar Remicade (infliximab), the branded version of which is marketed in Europe by Merck & Co.
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April 5, 2012
Panel backs pain drug studies with new safety checks
The wait may be over for drugmakers developing the first ever antibody-based painkillers. Despite safety concerns that led the FDA to temporarily halt nearly all trials involving these new agents, an advisory committee to the agency voted overwhelmingly last month to recommend allowing such studies to resume.
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March 18, 2012
Princeton venture capital firm and Russians collaborate on life sciences
Domain Associates is teaming up with the Russian government-backed investment group Rusnano in an ambitious deal to bring new medicines and medical devices to Russia’s emerging healthcare market.
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March 6, 2012
Pain-Wracked Migraine Patients’ Unmet Needs Targeted by Map’s Inhaled Drug
Companies led by Map Pharmaceuticals Inc. (MAPP) are pushing to develop better treatments for the 36 million Americans who get migraines. Regulators are set to announce this month if Map’s Levadex, an inhaled form of DHE that can be taken at home, can be marketed. If so, it may be worth $1 billion a year by 2020.
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March 1, 2012
Early Signs For Takeda’s TAK-875 Suggest The GPR40 Agonist Could Take On Other Oral Antidiabetics
Full publication of Phase II results for Takeda Pharmaceutical Co. Ltd.’s diabetes drug TAK-875 – the most advanced GPR40 agonist – in the Lancet Feb. 27 suggests a profile potentially competitive with other new oral classes, such as DPP-4 and SGLT-2 inhibitors.
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February 10, 2012
Alkermes readies for diabetic treatment push
CEO Richard Pops says Alkermes’ new Type 2 diabetes treatment has the potential to be an attractive choice for physicians and patients.
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February 8, 2012
ViewPoints: FDA throws weight behind Kalydeco
The FDA approval of Vertex’s cystic fibrosis (CF) therapy Kalydeco (ivacaftor) – over two months ahead of schedule – caught many by surprise. The decision both demonstrates decisiveness on the part of the regulator and a successful multi-faceted approach by Vertex to support approval.
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February 7, 2012
Spotlight On: Pfizer's Lipitor strategy
Will the post-expiry performance of Lipitor set a new trend?
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January 25, 2012
Five Big Drugs for 2012
These medications could boost the fortunes of companies like Pfizer, Gilead Sciences and Bristol-Myers Squibb.