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US regulators set to approve oral antiviral against COVID-19

The FDA looks set to authorise Merck’s molnupiravir after its advisory body recommended the antiviral treatment, while Pfizer’s Paxlovid may be next

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COVID-19 vaccines against Omicron may be fast-tracked

Regulators including the Food and Drug Administration (FDA) may treat Omicron-specific mRNA vaccines like seasonal flu vaccines, speeding up approval

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Omicron prompts global action

A new variant of concern discovered in southern Africa is quickly spreading around the world, prompting government to take action

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New COVID variant causing concern

An ‘unusual constellation of mutations’ in a new variant of the virus that causes COVID-19 has scientists worried that it could impact the efficacy of vaccines

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Gilead’s Trodelvy approved for triple-negative breast cancer in Europe

European patients with metastatic triple-negative breast cancer can now receive the antibody-drug conjugate as second-line monotherapy

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US FDA expands COVID-19 booster jabs to all adults

All Americans 18 and over are now eligible to receive a booster shot of either the Pfizer/BioNTech or Moderna COVID-19 vaccines

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US government to pay $5.3bn for Pfizer‘s Paxlovid

If approved by the FDA, the US government will purchase 10 million courses of Pfizer’s anti-COVID protease inhibitor antiviral therapy, Paxlovid, this year and into 2022

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Gilead to pay $745m for three oncology programmes from Arcus Biosciences

The deal will enable Gilead to accelerate the development of candidate molecules and explore treatment combinations with long-term partner Arcus Biosciences

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UK expands COVID-19 vaccine plans as winter approaches

The UK government will offer a booster dose of an mRNA COVID-19 vaccine to all adults aged 40 and a second Pfizer/BioNTech shot for 16- and 17-year-olds

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US President Biden nominates Robert Califf as FDA commissioner

Biden said Califf has both the experience and expertise to lead the FDA “during a critical time in our nation’s fight” against the coronavirus pandemic

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AstraZeneca signs for-profit agreements for its COVID-19 vaccine

The for-profit deals are aimed to ‘progressively transition the vaccine to modest profitability’ as COVID-19 moves from a pandemic to an endemic disease

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Regeneron’s COVID-19 antibody cocktail approved in Europe

Ronapreve (REGEN-COV in the US) has been approved for non-hospitalised, at-risk patients and for prevention of COVID-19

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