Shire has withdrawn its EU marketing application for its ADHDtransdermal patch product, Daytrana (methylphenidate transdermal system) for use in children, licensed from Noven. There are no plans to resubmit the filing.
Shire has withdrawn its EU marketing application for its ADHDtransdermal patch product, Daytrana (methylphenidate transdermal system) for use in children, licensed from Noven. There are no plans to resubmit the filing.
"Although we are disappointed with Shire's decision not to pursue European approval, our 2009 financial guidance did not include any...
Many assets outperform their pre-launch sales predictions despite the frequent overestimation of forecasts within the industry. In this article, Scrip highlights several such assets and the factors that influenced their predictions.
The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.
The China Securities Regulatory Commission has proposed a new “growth tier” for the STAR Market of the Shanghai Stock Exchange, to reinstate the market’s listing standards for unprofitable firms.
Highlights from Day Four of the BIO International Convention include Woodcock offering practical advice on rare disease trials, the sorry state of dealmaking mid-year, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
While some are calling for Syncona to be wound up, the UK-based company believes many existing and new investors will back the creation of new private fund.
