A new U.S. FDA approval adds adolescents to the population eligible for Cabenuva, the long-acting injectable HIV-1 treatment combining ViiV’s cabotegravir and Janssen’s rilpivirine, J&J announced Tuesday. Like adults, virologically suppressed adolescents age 12 and older can take the combo either monthly or every two months.
In related news, GSK subsidiary ViiV announced a Cabenuva label update last week. The FDA-approved update eliminates a mandatory oral lead-in with cabotegravir…
China’s National Medicinal Products Administration has approved Walvax’s bivalent HPV vaccine for the prevention of cervical cancer caused by HPV 16 and HPV 18, Chinese media sources reported last week.
The shot will compete for domestic market share against GSK, Merck, and China’s Xiamen Innovax.
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Moderna shared new Phase 2/3 data supporting the use of Spikevax in children under age 6.
Moderna claimed clinical trial success for its vaccine in children ages 6 months to under 6 years. An interim analysis of Phase 2/3 results showed…
The state of the fight:
Medicines Patent Pool sublicensed Pfizer’s Paxlovid to 35 generics manufacturers.
Medigen’s protein subunit vaccine (MVC-COV1901) offered similar safety and immunogenicity for adolescents as it did for adults, the Taipei-…
GSK’s pediatric formulation of tafenoquine, its single-dose radical cure for P. vivax malaria, has scored its first approval. Australia cleared the drug for children ages 2-15 (for use in combination with chloroquine), the Medicines for Malaria Venture (MMV) announced Monday.
The decision was supported by Phase 2b trial data showing that tafenoquine was 95% efficacious at preventing disease recurrence in children ages 6 months to 15 years for four months post-treatment.
The…
When ViiV Healthcare announced last week that it would not pursue a voluntary licensing deal for its long-acting HIV prevention shot, blowback was swift. Advocacy groups cried foul. STAT remarked on the “surprise move.” The company backpedaled within days, but its updated statement continued to indicate the GSK subsidiary would remain the sole supplier of long-acting cabotegravir, “at least during the initial years.”
The statement that triggered the furor was less obliging: “voluntary…
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Pfizer/BioNTech’s Comirnaty appeared to offer only 12% effectiveness against Omicron in children ages 5-11.
Pfizer/BioNTech’s Comirnaty is far less protective against infection in children…
The state of the fight:
Sanofi and GSK’s vaccine candidate demonstrated 58% efficacy against symptomatic Covid-19 in Phase 3.
The U.S. FDA lifted its clinical hold on Bharat Biotech’s Covaxin, clearing the way for the inactivated vaccine…
CureVac has dosed the first participant in a Phase 1 trial of its multivalent mRNA-based seasonal influenza vaccine candidate (CVSQIV) developed with GSK, CureVac announced last week. The companies inked an mRNA collaboration deal in 2020 when GSK invested in the German biopharma.
In other flu news, Cidara Therapeutics announced Monday that the U.S. FDA has accepted its Investigational New Drug (IND) application for the company’s universal influenza antiviral CD388. J&J’s Janssen…
The state of the fight:
A Lilly mAb active against Omicron won a U.S. FDA emergency use nod.AUTHORIZED VACCINES
J&J’s single-dose shot was only 53% efficacious against moderate to severe Covid-19 (28 days post-injection) in a final…