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FDA

Showing 15 posts of 1442 posts found.

FDA U-turn on Avandia

November 26, 2013
Sales and Marketing Avandia, CDER, FDA, GSK, diabetes, nissen, type 2

The FDA has delivered a shock verdict that the stringent restrictions on GlaxoSmithKline’s diabetes medicine Avandia should be lifted, despite …

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US regulator shows Nexavar green light

November 25, 2013
Sales and Marketing Bayer, Cancer, FDA, Nexavar, Onyx, thyroid

The FDA has extended the indication of liver and kidney cancer pill Nexavar to treat late-stage differentiated thyroid cancer. It …

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FDA approves Olysio

November 25, 2013
Sales and Marketing FDA, Janseen, Janssen, hep C, hepc, olysio, simeprevir

US regulators have approved Janssen Pharmaceuticals’ Olysio, a new therapy to treat chronic hepatitis C virus infection, after a priority …

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Gilead gets CHMP nod

November 25, 2013
Research and Development, Sales and Marketing CHMP, FDA, Gilead, chc, sovaldi

The CHMP has opened the way for Gilead Sciences’ first-in-class investigational chronic hepatitis C drug Sovaldi (sofosbuvir) to get to …

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Janssen/Pharmacyclics gain FDA nod for Imbruvica

November 14, 2013
Sales and Marketing FDA, Janssen, Pharmacyclics, Revlimid, Velcade

The FDA has approved Janssen and Pharmacyclics’ Imbruvica to treat patients with mantle cell lymphoma (MCL), a rare and aggressive …

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EMA delays data transparency

November 14, 2013
Medical Communications, Research and Development, Sales and Marketing EMA, FDA, all trials, transparency

The European Medicines Agency has delayed its much-trailed plan to launch a clear policy on making clinical trial data publically …

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Sanofi to produce weight-loss drug for Orexigen

November 11, 2013
Manufacturing and Production, Sales and Marketing Contrave, FDA, Sanofi, orexigen

Sanofi has agreed a deal to manufacture Orexigen Therapeutics’ weight-loss candidate Contrave outside North America. Under the commercial supply agreement, …

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‘Fatal’ safety concerns throw doubt on Lemtrada

November 11, 2013
Research and Development, Sales and Marketing FDA, Genzyme, Lemtrada, MS, Sanofi

An FDA committee has dashed hopes of an approval for Sanofi’s multiple sclerosis drug after saying its benefits may not …

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Bayer submits Eylea in EU for DME

November 8, 2013
Sales and Marketing Bayer, DME, EMA, Eylea, FDA

Bayer HealthCare is seeking to extend the licence of its VEGF Trap-Eye, which is already marketed as Eylea in various …

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FDA takes further action on drug shortages

November 4, 2013
Manufacturing and Production, Sales and Marketing FDA, Obama, US, drug shortages

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FDA approves Roche’s new leukemia drug

November 4, 2013
Research and Development, Sales and Marketing Arzerra, CLL, FDA, GSK, Roche, chronic lymphocytic leukaemia

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Ariad cancer drug pulled amid safety fears

November 1, 2013
Sales and Marketing Ariad, FDA, iclusig, leukaemia

Ariad Pharmaceuticals has been forced by the FDA to suspend sales of its blood cancer drug Iclusig given the high …

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FDA speed reviews raises drug safety concerns

October 30, 2013
Medical Communications, Research and Development, Sales and Marketing FDA, JAMA

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‘Game-changing’ hep C pill gets FDA panel nod

October 29, 2013
Sales and Marketing FDA, Gilead, hep C, sofosbuvir

Gilead Science’s investigational hepatitis C drug sofosbuvir is one step closer to approval in the US after an FDA advisory …

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Positive CHMP verdicts for Actelion and Lundbeck

October 28, 2013
Sales and Marketing Actelion, CHMP, FDA, Lundbeck

Actelion and Lundbeck both took a step closer to EU approval for two drugs seen as pivotal to their future …

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