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Ridgeback Biotherapeutics LP

https://www.ridgebackbio.com/

Latest From Ridgeback Biotherapeutics LP

Paxlovid Prescribing Complicated By Dosing Adjustment For Renal Impairment, Drug-Drug Interactions

In the EUA for Pfizer’s COVID-19 oral antiviral treatment, US FDA required a reduced dose for some renally impaired patients that is ‘incongruent with how Paxlovid is packaged,’ meaning that pharmacists have to manually make changes to each blister pack. Prescribers will have to navigate an extensive list of contraindicated medicines due to CYP3A effects.

Drug Review Coronavirus COVID-19

Merck/Ridgeback’s COVID-19 Drug Molnupiravir Met EUA Bar, But More Data Needed For Full Approval – US FDA

Reviewers believed it was worth making the oral antiviral available for second-line use under the relatively low bar for emergency authorization despite the drug’s significant potential risks, ‘modest benefit’ and ‘unexplained difference’ in efficacy results from the interim and full analysis populations in the pivotal trial.

Drug Review Coronavirus COVID-19

Generics Industry At The Forefront In War Against COVID-19 In 2021

As the COVID-19 pandemic continued in 2021, the off-patent industry stepped in to provide relief in a variety of ways, whether through securing supplies of essential medicines or helping to manufacture and distribute newly-developed treatments.

Biosimilars Coronavirus COVID-19

2021 Saw India Enable Accelerated Regulatory Pathways – Can It Become The Norm?

India saw a raft of vaccine and drug approvals in 2021, backed by pandemic-related accelerated regulatory processes, and outlined its intent to step up biopharma innovation in the country.  Pharma wants some of the regulatory flexibility to stay, though experts are seeking increased transparency in the overall approach.

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