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…
The state of the fight:
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 a “…
Unitaid will fund “two large-scale operational projects” distributing long-acting injectable HIV pre-exposure prophylaxis (PrEP) to at-risk populations in Brazil and South Africa, the WHO-hosted agency announced last week.
ViiV Healthcare—recently under fire for its reluctance to pursue voluntary licensing for the cabotegravir-based shots—will donate supplies. But the donation didn’t exempt the GSK subsidiary from pricing scrutiny from Unitaid’s executive director, who publicly urged…
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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-based…
J&J and three U.S pharmaceutical distributors have finalized a $26 billion settlement agreement over their roles in the U.S. opioid epidemic, according to multiple press releases last week. The development was triggered by “a sufficient level of participation” among claimants, according to J&J. The Washington Post reported that 46 out of 49 states have agreed to participate.
As a result, J&J will fulfill its promised payments of up to $5 billion.
The state of the fight:
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 ages…
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 to…
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 analysis…
The state of the fight:
South Africa’s Afrigen has produced the first batch of its version of Moderna’s mRNA-based vaccine.REGULATORY UPDATES
Pfizer and BioNTech have begun rolling data submission for authorization of their Comirnaty shot in children between ages 6 months and 5 years “at the request” of the U.S…