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In this week's podcast edition of Five Must-Know Things: new mRNA vaccine deal for Pfizer and BioNTech; court ruling helps Novartis’s Gilenya; first cut-price generic Paxlovid launched; breaking down BridgeBio’s Phase III failure; and a look at gene editing companies to watch at JP Morgan.
While an mRNA vaccine is still missing, 2021 saw Indian companies strike alliances, battle legal action and gain funding while the regulator played a crucial enabling role in the run up to the approval of eight COVID-19 vaccines from zero in 2020.
The companies’ third vaccine-development deal shows how COVID cash has also led mRNA-focused companies to beef up their organic pipelines amid talk of a merger wave.
The FDA authorized Comirnaty as a booster shot for 12- to 15-year-olds, as J&J's vaccine has shown effectiveness as a booster in Omicron-dominant settings. Meanwhile, Pfizer's Paxlovid won approval in the UK, and Novavax submitted the final data for its vaccine to the FDA.
2021 may have been dominated by the continuing coronavirus pandemic, but that did not stop industry’s more bread and butter R&D activities. Here, Scrip takes a look at five of the more notable clinical trial hits of the year that got readers clicking.
Bangladesh’s Beximco signed off 2021 on a high launching the first generic version of Pfizer’s Paxlovid at about $186 for a five-day treatment course and claimed that it has ‘adequate capacities' for exports as well.
Oral antivirals make progress in Asia as Japan issues emergency approval to Merck's Lagevrio in a matter of weeks and South Korea clears Pfizer's contender Paxlovid. Vaccines also move forward in both countries with deals for boosters, new supply agreements and the advancement of home-grown candidates.
US regulators have granted emergency authorization to the antiviral molnupiravir but only for use when "alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate."
The US FDA’s Christmas gift was the authorization of the first oral pill for treatment of mild-to-moderate COVID-19; Pfizer expects to have 30 million doses of Paxlovid available by mid-2022.
Ridinilazole fell short of significance in a late-stage trial, with some analysts now anticipating the company will alter its therapeutic strategy entirely.
A long-acting injectable formulation of cabotegravir, Apretude could result in greater patient adherence to therapy, ViiV claims. The product will be priced at $3,700 per vial.
Phase III data for the novel echinocandin demonstrated non-inferiority to caspofungin for all-cause mortality at day 30 and for global cure at day 14. Regulatory filings are planned for 2022.
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