Johnson & Johnson's quadruple HIV combination is likely to win a positive recommendation for approval in Europe this week – but clever positioning will be required to secure strong uptake for the combination considering its late entry onto a competitive market place.
Johnson & Johnson's HIV combination therapy, darunavir/emtricitabine/cobicistat/tenofovir alafenamide, is likely to get a positive recommendation this week from the European Medicines Agency's scientific committee, the CHMP – a vote that will set up the product for its first approval worldwide.
However, Janssen Pharmaceutical Co. (J&J's pharma business) will need to focus on positioning D/C/F/TAF as a second-line treatment alternative if...
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.
The Phase III trial met the primary endpoint of time to clinical worsening in patients newly diagnosed with pulmonary arterial hypertension.
As competition heats up and the obesity market matures, the two frontrunners are tailoring their studies to the wants and needs of different patient groups.
The off-the-shelf stem cell therapy shows sustained glycemic control and a high rate of insulin independence.
