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Allos’ NSCLC Drug Folotyn Extends Overall Survival

Thu, 07/29/2010 - 01:30 — Correspondent

Allos Therapeutics’ Folotyn demonstrated clinical activity compared with Genentech/OSI Pharmaceuticals’ Tarceva in a second-line treatment study of advanced non-small cell lung cancer (NSCLC) patients, top-line results show.

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FDA Advisory Panel Votes to Approve AstraZeneca’s Brilinta

Thu, 07/29/2010 - 01:30 — Correspondent

An FDA advisory committee has recommended approval of AstraZeneca’s blood thinner Brilinta.

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Thu, 07/29/2010 - 01:30 — Correspondent

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FDA Advisory Committees’ Waivers Would Become Public Under House Bill

Thu, 07/29/2010 - 01:30 — Correspondent

Advisory committee member waivers, including those granted by the FDA, would have to be publicly disclosed 15 days before each meeting, under a bill passed Monday by the House.

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FTC Sees Rise in Pay-For-Delay Settlements

Thu, 07/29/2010 - 01:30 — Correspondent

With three months left in fiscal 2010, the FTC has seen a rise in the number of “pay-for-delay” settlements between brand- and generic-drug makers, with 21 recorded between October 2009 and June 2010.

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FDA Advisory Panel to Consider Surrogate Endpoints for Pediatric PAH Drugs

Thu, 07/29/2010 - 01:30 — Correspondent

An FDA advisory committee will debate whether using pulmonary vascular resistance index (PVRI) changes rather than changes in exercise capacity is an effective endpoint to use in clinical trials evaluating pulmonary arterial hypertension (PAH) drugs in children.

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Full Issue

Wed, 07/28/2010 - 01:30 — Correspondent

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NICE to Reconsider Celgene’s Vidaza for Severe Blood Disorder

Wed, 07/28/2010 - 01:30 — Correspondent

The UK’s National Institute for Health and Clinical Excellence will reappraise Celgene’s Vidaza (azacitidine) in patients with higher-risk myelodysplastic syndrome (MDS), following separate appeals by Celgene and a coalition of patient and professional groups.

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Teva Says Clinical Trials Necessary for a Copaxone Generic

Wed, 07/28/2010 - 01:30 — Correspondent

Any generic version of Teva’s blockbuster multiple sclerosis treatment Copaxone would need clinical trials to gain approval, the company says in response to speculation that the FDA might approve a generic Copaxone using the same criteria as applied to generic Lovenox.

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Wed, 07/28/2010 - 01:30 — Correspondent


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