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- PMLiVE

Generic Pharmaceutical Association

- PMLiVE

FDA approves first pre-exposure prophylactic against COVID-19

AstraZeneca’s (AZ) Evushield offers long-acting protection against COVID-19 in people who are either unable to receive or mount an insufficient response to a vaccine

- PMLiVE

AstraZeneca and Ionis sign $3.6bn deal for eplontersen

The liver-targeted antisense therapy is in phase 3 trials for the treatment of transthyretin amyloidosis, a systemic, progressive and fatal condition

- PMLiVE

Keytruda gains eighth FDA approval this year

Merck’s megablockbuster Keytruda has returned to its roots with a new indication in melanoma, the therapy area where it was first approved seven years ago

- PMLiVE

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

- PMLiVE

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

- PMLiVE

bluebird bio’s beti-cel accepted for priority review by FDA

The tough journey to approval for beta-thalassemia gene therapy (beti-cel) in the US may be coming to an end, with approval possible by 2022

- PMLiVE

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

- PMLiVE

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

Biogen Idec building

Biogen investigating death linked to Aduhelm

The death of a 75-year-old patient taking Biogen’s Aduhelm has raised yet more questions around the recently approved Alzheimer’s therapy

- PMLiVE

Pfizer’s oral antiviral Paxlovid significantly cuts risk of severe COVID-19

Pfizer has halted its phase 2/3 trial of its new antiviral combo Paxlovid after analysis shows it cuts the risk of hospitalisation or death from COVID-19 by nearly 90%

- PMLiVE

bluebird bio splits to create new oncology firm 2seventy bio

2seventy bio gets the company’s immune-oncology cell therapies products, while bluebird bio will continue its work on severe genetic diseases

- PMLiVE

Bespoke Gene Therapy Consortium created to collaborate in development of rare disease gene therapies

Ten pharma companies will team up with the FDA, NIH and five non-profits to accelerate the development of gene therapies to treat rare inherited diseases

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