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…
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…
Leyden Labs has raised $140 million in Series B financing, the intranasal therapeutic specialist announced Tuesday.
Leyden will use the funds to advance PanFlu, its preclinical monoclonal antibody influenza treatment candidate. Last week, the Netherlands-based company licensed PanFlu for mucosal administration from J&J’s Janssen, per a separate press release.
Former Vir executive Suha Jhaveri, who joined Leyden as chief commercial officer and head of business development in…
The state of the fight:
A booster dose of Bharat Biotech’s Covaxin increased neutralizing antibodies up to 265-fold.
AUTHORIZED VACCINES
Two doses of Pfizer/BioNTech’s vaccine reduced the risk of Covid-19 hospitalization by 94% among adolescents ages 12…
The state of the fight:
India granted Biological E’s Corbevax—a low-cost, patent-free vaccine—its first regulatory authorization.
AUTHORIZED VACCINES
Bharat Biotech’s Covaxin generated “superior antibody responses” in children…
The state of the fight:
Oral antivirals from Pfizer and Merck notched U.S. FDA authorizations.AUTHORIZED VACCINES
The AstraZeneca/Oxford vaccine starts waning in protection against serious illness within three months of the second dose, according to cohort studies in Brazil and Scotland published…
The state of the fight:
WHO issued an Emergency Use Listing for Serum Institute of India’s version of Novavax’s vaccine.AUTHORIZED VACCINES
A U.S. CDC advisory panel recommended mRNA-based vaccines over the J&J jab, citing blood clot side effects stemming from the single-dose…
The state of the fight:
New studies supported heterologous primary regimens and heterologous boosters.
AUTHORIZED VACCINES
Mixing the AstraZeneca/Oxford or Pfizer/BioNTech vaccines with a second dose of Moderna’s shot generated non-inferior immune responses …
The state of the fight:
A slew of vaccine manufacturers announced plans to tackle the Omicron variant.AUTHORIZED VACCINES
New research on the Pfizer/BioNTech shot affirmed its efficacy in younger people and its safety in older people.
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What role can vaccines play in combatting antimicrobial resistance? A public-private partnership seeks to answer that question through an open-source, web-based analytic platform, Germany’s European Vaccine Initiative (EVI) announced last week.
The PrIMAVeRa project—coordinated by EVI and backed by $10.3 million from the Brussels-based Innovative Medicines Initiative—joins GSK, Janssen and Pfizer with 16 academic and SME partners across the E.U., Russia and the U.K.
The five-year…