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New Patent Battles Emerge Over What Lipid Technology Is Used In mRNA COVID-19 Vaccines

 
• By Brenda Sandburg

Alnylam seeks royalties, claiming its lipid nanoparticle technology is a component of both Moderna’s and Pfizer’s vaccines. Moderna calls Alnylam’s suit ‘blatant opportunism.’ Acuitas sues Arbutus seeking declaratory judgement that Comirnaty does not infringe its LPN technology.

mRNA vaccines
Lipid technology used in mRNA COVID-19 vaccines is at center of patent suits • Source: Alamy

Alnylam Pharmaceuticals Inc. is the second company claiming its lipid technology is being used in mRNA COVID-19 vaccines. It is seeking royalties from both Moderna, Inc. and Pfizer Inc., putting potentially hundreds of millions of dollars at stake in the litigation.

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Kennedy’s Comments On Novavax Delay Scientifically, Legally Inaccurate, Experts Say

 
• By Sarah Karlin-Smith

The HHS Secretary publicly acknowledged the unusual delay of Novavax's COVID-19 vaccine licensure, but his justification was neither scientifically accurate nor legally justifiable, experts said.

‘Highly Problematic’: Acting FDA Commissioner Paused Planned OK Of Novavax Shot

 
• By Sarah Karlin-Smith

Former Acting FDA Commissioner Sara Brenner is said to have asked Tracy Beth Høeg, new special assistant to the commissioner, to help reexamine the application. Høeg’s position at the agency is raising concerns about the FDA's ongoing approach to vaccine regulation.

Updated: US FDA Commissioner Makary Was Sworn In, Knew Of Plan to Push Out Marks, Sources Say

 
• By Sarah Karlin-Smith

FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.

Peter Marks Resigns From US FDA, Warns Kennedy Does Not Want Truth On Vaccines

 
• By Sarah Karlin-Smith

In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."

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Japan Looks To Build Domestic Capacity In New Modalities

 
• By Lisa Takagi

Japan's trade ministry is providing new support to build domestic capacity for new modalities including cell and gene therapies, as part of wider efforts to support the national bioventure ecosystem.

GLP-1 Drug Coverage Growing For Obesity In Medicaid, But Only For Diabetes In Medicare

 
• By Cathy Kelly

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US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.