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Abliva’s NV354 receives ODD from US FDA

Pharma Leaders

Sweden-based Abliva has announced that its drug candidate NV354 has been received orphan drug designation (ODD) from the US FDA Office of Orphan Products Development to treat mitochondrial disease. FDA is a validation of the quality of the NV354 pre-clinical program and another important milestone for Abliva.

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Pharmaceutical Sales Training: Mastering the Art of Modern Pharma Sales

Contrarian Sales Techniques

It's the secret sauce to thriving in the pharma industry. From cutting-edge training techniques that break the mold, to the latest industry trends making waves, and the career development hacks every pharma rep should know – we've got it all covered. Welcome to the world where sales training isn't just a formality.

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Novartis drops presbyopia drug acquired with Encore Vision

pharmaphorum

Interim results from the phase 2b study in patients aged 45 to 55 years with presbyopia showed that the drug did not achieve a statistically significant dose response three months after starting treatment, missing its primary endpoint. It is estimated that more than 80% of adults over the age of 45 develop the condition.

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Astellas loses bid to block Lexiscan generics in US

pharmaphorum

It looks like Astellas has been unsuccessful in its attempt to block Pfizer’s generic medicines unit Hospira from launching a copycat version of big-selling pharmacologic stress agent Lexiscan in the US. AmphaStar and Glenmark Pharma also claimed FDA approval for versions of the drug earlier this year.

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How NLP Helps Life Sciences Companies Unlock Insights from Drug Labels

PM360

Food and Drug Administration (FDA) or European Medicines Agency (EMA). Understanding patient sub-group exceptions for competitive or for label development purposes. International sources: The focus for many labeling teams is on major sources such as FDA and EMA. Example: Top Pharma Company Using NLP to Explore Drug Label Data.

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Astellas facing generics to big-selling Lexiscan product in US

pharmaphorum

Astellas has won a reprieve in its attempt to stop Pfizer’s generic medicines unit Hospira launching a copycat version of its pharmacologic stress agent Lexiscan in the US – but only for a couple of weeks. AmphaStar and Glenmark Pharma also claimed FDA approval for versions of the drug earlier this year.

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Madrigal sees road to approval for NASH drug resmetirom

pharmaphorum

The road to the development of treatments for non-alcoholic steatohepatitis (NASH) is littered with failed projects, but US biotech Madrigal Pharma thinks it now has enough evidence for its drug resmetirom to support regulatory filings. Although, so far efforts to bring a therapy to market have failed.