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The Israeli biotech announced disappointing Phase II/III data for opaganib while expanding its Phase II/III RHB-107 study. Pharming unveiled promising data from a company-sponsored study, but an imbalance in an investigator-led study confounded results, while CalciMedica built on the case for its drug as a treatment for COVID-19 pneumonia.
Ex-WHO executive and co-chair of the Asia Pacific Immunization Coalition, Tikki Pangestu, outlined at a recent briefing why he believes herd immunity for COVID-19 will not be achievable against the backdrop of the global spread of the highly contagious Delta variant. Facets of vaccine hesitancy and the complexity of vaccine manufacturing were among the other issues discussed by experts.
The company plans to make a new EUA request prior to filing a BLA, but does not yet have a specific timeline. Meanwhile, it has been preparing for the drug’s distribution as a COVID-19 treatment.
The company’s triple-combination studies with vebicorvir and next-generation core inhibitor programs may hold more promise in hepatitis B.
Takeda and Moderna have identified the source of metallic particles in some lots of mRNA-1273 in Japan, but believe the two deaths identified to be coincidental. Pfizer starts protease inhibitor trial, and Rigel reports fostamatinib data.
With a CD8-targeting IL-2 mutein as its lead program, the start-up is developing cis-targeted immunotherapies that selectively target two molecules on the same immune cell for improved efficacy and safety.
Solid Phase II data for Bavarian Nordic’s investigational vaccine MVA-BN RSV showed falls in both symptoms and viral load of respiratory syncytial virus in the challenge trial’s adult participants, boosting prospects for a Phase III trial - and for finding a commercial partner.
Another vaccine failure shows that HIV’s ability to “attack, hijack and evade” the human immune system is still outwitting researchers, but J&J will continue with Phase III study of a related vaccine.
Also, Moderna completed the submission of the BLA for mRNA-1273’s FDA approval, Pfizer starts a rolling submission for a booster shot and Brii Biosciences announced data for its two-antibody antiviral cocktail, and Japan withdraws selected lots of Moderna's vaccine over contamination worries.
Pfizer and BioNTech sent in Phase I data for a third dose of BNT162b2 to support future licensure, Gritstone bio will work with CEPI to develop its second-generation vaccine in South Africa and other areas, and Roche Genentech expects a shortage of the drug Actemra to last for several weeks amid a surge in cases.
In a series on articles, Scrip takes a look at some of the key novel products expected to reach the market in 2022 in a cross-section of therapy areas. Here, with input from Biomedtracker, are six new anti-infectives expected to reach the market for the first time next year, all with an above average likelihood of approval.
Moderna may benefit from data indicating strong efficacy against the Delta strain, though an analyst pointed out that they come with some important caveats.
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