The approval for the GW Pharmaceuticals drug covers the treatment of Lennox-Gastaut syndrome and Dravet syndrome, two forms of rare and severe childhood epilepsy – the US agency was quick to clarify what the approval did not cover, chiefly marijuana.
The buzz has been high around the US FDA's approval of GW Pharmaceuticals PLCEpidiolex (cannabidiol) for the treatment of Lennox-Gastaut syndrome (LGS) and Dravet (DS) syndrome, in what the agency is calling "the first FDA-approved drug that contains a purified drug substance derived from marijuana."
But in a response geared toward the broader public perception that is bound to take place, Commissioner Scott Gottlieb did...
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.
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.
Fresh from having sold Anthos to Novartis, the new CEO is expected to update the oncology and dermatology-focused firm's strategy.
Green light follows a recent rejection by the US FDA to partner Regeneron's request for an extension to the dosing interval.
Recent moves in the industry include C-suite changes at Atalanta Therapeutics and Climb Bio, plus seven companies get new CMOs.
