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Author Archives: George Koroneos
Merck KGaA MS Drug on the Fast Track
Merck KGaA received word July 25 that its application for the multiple sclerosis treatment Cladribine had received priority review status by FDA, decreasing the evaluation period from 10 months to six months, and closing the gap between Merck and the competition.
“This is a critical milestone on the path to potential approval for short-course therapy with [...]
Advisory Panel Rejects Avastin For Breast Cancer Treatment
An FDA advisory panel on Tuesday voted 12–1 to discontinue Avastin (bevacizumab) as a treatment for advanced breast cancer due to post-market studies stating that the treatment does not to increase patient lifespan by any significant length of time.
This is a huge problem for Roche who purchased the treatment as part of its merger with [...]
Posted in FDA, Safety Tagged Avastin, Bevacizumab, Breast cancer, Cancer, Chemotherapy, Clinical trial, Food and Drug Administration, Genentech, Roche 1 Comment
HIV Market Banking on Fixed-Dose Treatments
The HIV markets are expected to grow for the next two years, but major patent expirations in the following years will have a huge impact on pharmaceutical sales by 2019, according to a new report by DataMonitor.
Antiretroviral sales in 2009 were estimated at $11.8 billion. While that figure is forecast to hit $14.4 billion in [...]
AZ Celebrates Crestor Patent Win
The US District Court in Delaware upheld AstraZeneca’s patent for its blockbuster statin Crestor (rosuvastatin), ending a dispute that could have crippled the drugmaker’s billion-dollar cash cow.
Crestor’s patent is not scheduled to expire until 2016. However, a group of generics firms had claimed that a substance patent (314) protecting one of the active ingredients in [...]
Novartis Hits Regulatory Snag with Facebook Widget