Latest Intelligence on Pharmaceutical Contract Research Organizations

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Type Product title / description Pub Price
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

Biocontrol Ltd: novel approach for treatment of Pseudomonas

A small UK company has presented positive results from a Phase II trial investigating the use of bacteriophages for the treatment of Pseudomonas infections. The product, while still in the early stages of clinical development, represents a novel approach to the treatment of bacterial infections and offers a crucial new avenue of research in the treatment of Pseudomonas.

Published By Datamonitor
27 Feb 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

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

Medivation: Dimebon ever closer to Alzheimer's market

Medivation is set to announce trial data regarding behavioral symptoms and the impact on caregivers relating to its Alzheimer's disease drug, Dimebon. Positive findings will enhance the validity of the impressive Phase II clinical trial data published in 2007. Dimebon is forecast for a 2011 launch, and is expected to account for 15% ($1.5 billion) of the $9.5 billion AD market by 2017.

Published By Datamonitor
14 Mar 2008
CommentWire
CommentWire

AstraZeneca: Zactima development continues apace in lung cancer

The continuing development of Zactima in non-small-cell lung cancer will be welcome news for AstraZeneca, following the recent failure of Recentin in the same indication. Success in this indication now hinges on whether Zactima's mechanism of action can translate into notable clinical benefit.

Published By Datamonitor
14 Mar 2008
CommentWire
CommentWire

Basilea: FDA issues approvable letter for ceftobiprole

Basilea has received an approvable letter from the FDA for its new drug, ceftobiprole. Against the backdrop of investigations into the safety of Ketek, and considering the scrutiny Telavancin has endured, the letter is yet another indication of the FDA's more rigorous and defensive approach to the drug approval process.

Published By Datamonitor
18 Mar 2008
CommentWire
CommentWire

Vertex: Positive results for cystic fibrosis drug

Vertex has completed a Phase II trial of a small-molecule oral drug, VX-770, which targets the basic defect that occurs in cystic fibrosis (CF). The trial has only been performed in 20 patients from a small, genetically distinct subset of the CF population. However, the results are encouraging and indicate an alternative approach to traditional reactive management of CF.

Published By Datamonitor
28 Mar 2008
CommentWire
CommentWire

Genentech/Roche: mixed lung cancer data for Avastin

Genentech has announced an update from the AVAiL Phase III study of Avastin in non-small cell lung cancer, showing improved progression-free survival. The proven efficacy of Avastin in combination with different chemotherapy regimens may lead to a modest increase in uptake, although the lack of overall survival benefit reported in this trial will leave it exposed to competition from Erbitux.

Published By Datamonitor
22 Apr 2008
CommentWire
CommentWire

Generic penicillins: boosted by FDA's back-to-basics for S.pneumoniae

According to the Infectious Disease Society of North America, the FDA has changed the 'breakpoints' used to determine the susceptibility cut-off for penicillins in the treatment of Streptococcus pneumoniae pneumonia. This will reinvigorate this largely genericized antibiotic class, and is indicative of increasing pressure on antibiotics as efforts are made to restrict antibiotic resistance.

Published By Datamonitor
30 Apr 2008

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