GSK gets European OK for HIV drug Juluca; Akari dealt non-compliance notice from Nasdaq

→ GSK’s ViiV has snared a European approval for Juluca, which the pharma giant touts as the first 2-drug, once-daily, single pill regimen OK’d for HIV. The drug is a combination of ViiV’s dolutegravir 50mg with J&J’s rilpivirine 25mg. “The European Commission Decision for Juluca is very positive news for people living with HIV (PLHIV) across Europe, who will now have the opportunity to maintain their viral suppression with a complete treatment regimen composed of only two drugs within a single-pill,” said ViiV CEO Deborah Waterhouse.

Akari Therapeutics is scrambling to keep its position on the Nasdaq $AKTX after failing to file an annual report on time. The exchange is giving Akari 60 days to submit a plan to regain compliance with Nasdaq’s filing requirements for continued listing, and the company says it plans to do so. If Nasdaq is happy with their compliance plan, it can grant an extension up until November 12 for Akari to refile its Form 20-F. Akari has been using a 20-F in lieu of a 10-K as it also has a foot in London. This comes just days after the New York City-based biotech ousted its former CEO David Horn Solomon for allegedly abusing the company credit card — its second chief executive to step down amid scandal in a year.

Novo Nordisk reported this morning that adults with haemophilia B who received a single dose of their drug Refixia (nonacog beta pegol; N9-GP) “achieved greater total factor IX exposure than those treated with rFIXFc (recombinant factor IX-Fc fusion protein).”  The head-to-head paradigm7 trial results were presented at the WFH 2018 World Congress in Glasgow, UK.

Bioasis Technologies and WuXi Biologics have struck an initial strategic collaboration deal for the development and manufacturing of xB3-001, Bioasis’ lead investigational biological candidate to treat brain cancer.

The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 44,100+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

Visit Endpoints Careers ->