The U.S. FDA cleared the Investigational New Drug (IND) application for the intranasal RSV vaccine candidate (BLB-201) from Georgia-based CyanVac and its Californian subsidiary, Blue Lake Biotechnology, the companies announced Monday.
The move paves the way for Phase 1 trials, which will test BLB-201 in healthy adults ages 18-75, the press release said.
In other RSV news, Pfizer’s candidate shot (RSVpreF) won U.S. FDA Breakthrough Therapy designation for prevention of RSV in…
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.
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…
Pfizer’s C. difficile vaccine candidate (PF-06425090) failed to meet the primary endpoint in a Phase 3 trial, the company announced Tuesday. At final analysis, the shot showed just 31% efficacy at preventing infection after three doses, according to a Pfizer press release. Nonetheless, the jab’s 100% efficacy at preventing “medically attended” infection—a secondary endpoint—suggested a possible future direction for the product, Endpoints News reported.
In more promising news, Pfizer’s…
Moderna’s mRNA-based RSV vaccine candidate (mRNA-1345) has advanced to Phase 3 in adults age 60 and older, the Massachusetts-based company announced Tuesday. The U.S. FDA Fast Track-designated shot joins RSV candidates from J&J and Pfizer in late-stage trials. Numerous other vaccine makers are also in the race to bring the first RSV jab to market.
In other RSV news, Enanta Pharmaceuticals last week touted positive Phase 2 data on EDP-938, the Massachusetts-based firm’s N-protein…
Bavarian Nordic’s RSV vaccine candidate (MVA-BN RSV) has notched U.S. FDA Breakthrough Therapy designation for adults age 60 and older on the strength of preliminary clinical evidence, the Denmark-based company announced Monday. The news follows earlier Phase 2 data showing the candidate resulted in a “statistically significant” reduction of viral load and up to 79% efficacy in preventing symptomatic RSV infections in adults ages 18-50.
The company said it plans to start a Phase 3…
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…
Gilead will pay rival ViiV $1.25 billion upfront and a 3% royalty on future U.S. sales (through 2027) of its once-daily single-tablet Biktarvy regimen—bictegravir, emtricitabine and tenofovir alafenamide—as part of a patent infringement settlement, ViiV’s parent company announced Monday.
The GSK subsidiary filed suit against Gilead in 2018, claiming that the bictegravir component of Biktarvy infringed on ViiV’s patents relating to its dolutegravir HIV drug and other compounds.
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The U.S. FDA gifted Moderna a Priority Review Voucher (PRV) when it approved the Massachusetts-based company’s Covid-19 vaccine on Monday, according to an agency letter.
Moderna has yet to disclose plans for its voucher. On the resale market, PRV values have fallen sharply from their 2015 high of $350 million, with more recent sales coming in around $100 million.