J&J's Quad HIV Combo Likely To Pass CHMP; EU Market Uptake Is Trickier
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.
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Sales of Gilead's TAF-based regimens for HIV continue to grow and should be augmented by elvitegravir successor bictegravir. The company's future growth is unclear, however, without M&A.
The European Medicines Agency’s key scientific committee, the CHMP, has recommended for approval throughout Europe a total of 11 new drugs. Two medicines received a negative opinion from the committee and the marketing authorization application for one product has been withdrawn. A further eight products are set to receive indication extensions. The medicines that got positive opinions are likely to secure official approval within the next few months.
The European Medicines Agency’s key scientific committee, the CHMP, is deciding this week whether a dozen or so new medicines that are in the final stages of the evaluation process should be approved for marketing across the EU. The committee will discuss 13 initial marketing authorization applications.