Opinion on Pharmaceutical Contract Research Organizations in United States

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Type Product title / description Pub Price
CommentWire
CommentWire

Orexigen: Contrave joins the list of failed weight-loss drugs

The FDA has issued a Complete Response Letter informing Orexigen that its developmental obesity therapy Contrave will require additional clinical study if it is to reach the market. The financial burden of an outcomes study and uncertainties regarding the drug's effect on blood pressure is likely to prevent Contrave from entering the market.

Published By Datamonitor
02 Feb 2011
CommentWire
CommentWire

New Drug Applications: FDA increases focus on data integrity

The fact that the New Drug Application for Theravance's antibiotic is being delayed by further investigations into monitoring issues at its study sites shows that the FDA is getting serious about reconsidering its drug approval processes.

Published By Datamonitor
04 Mar 2008
CommentWire
CommentWire

Lilly: shifts R&D burden

Eli Lilly has announced that it will hand over a large proportion of its R&D efforts to contract research organization Covance. The deal, which involves Covance acquiring Lilly's 1,700-acre R&D site at Greenfield, is one of a number of major structural changes engineered by Lilly to improve its fiscal performance in the face of increasing market pressures, particularly the impact of generic drugs.

Published By Datamonitor
07 Aug 2008
CommentWire
CommentWire

Kyowa Hakko: non-approvable letter for Parkinson's treatment

The FDA's non-approvable letter for istradefylline (KW-6002) represents a major setback for Kyowa Hakko. The company had intended for the novel drug to gain approval as an adjunctive treatment in advanced Parkinson's disease. However, the FDA's decision is good news for Eisai, as it will reduce competition to its late-stage Parkinson's disease compound, E2007.

Published By Datamonitor
28 Feb 2008
CommentWire
CommentWire

Genentech: US approval for Avastin in breast cancer on the horizon

Despite its advisory panel's recommendation, the FDA has granted accelerated approval for Avastin in HER2-negative metastatic breast cancer. A full approval can only be granted after the FDA reviews the results from further studies. However, it is unlikely that any new or unexpected safety concerns will be of sufficient significance to prevent full approval for Avastin in this indication.

Published By Datamonitor
27 Feb 2008
CommentWire
CommentWire

Abbott: meta-analysis is good news for psoriasis drug but approval remains a hurdle

A new article in the Journal of the American Medical Association reveals that interleukin-12/23 inhibitors such as Abbott's Ozespa do not raise cardiovascular risks in psoriasis patients compared to placebo or TNF inhibitors. Abbott will welcome the news, but Datamonitor believes that while Ozespa is a key contender if resubmitted for approval, hurdles remain as more extensive data are needed.

Published By Datamonitor
24 Aug 2011

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