Biologics

Moderna Files Patent Suit Against Pfizer/BioNTech

Moderna has filed a patent infringement lawsuit against Pfizer/BioNTech in Massachusetts federal court over their Comirnaty Covid-19 vaccine. Moderna alleges that the vaccine “infringes patents Moderna filed between 2010 and 2016 covering Moderna’s foundational mRNA technology. This groundbreaking technology was critical to the development of Moderna’s own mRNA Covid-19 vaccine, Spikevax. Pfizer and BioNTech copied this technology, without Moderna's permission, to make Comirnaty.”

Moderna says that it had pledged in 2020 at the beginning of the pandemic to not enforce its Covid-related patents while the pandemic continued. “In March 2022, when the collective fight against Covid-19 entered a new phase and vaccine supply was no longer a barrier to access in many parts of the world, Moderna updated its pledge,” the company says. It expected companies like Pfizer and BioNTech to respect its intellectual property rights and would consider a commercial license should they request one, but they “failed to do so,” Moderna says.

Pfizer had this to say in a statement provided to FDA Webview 8/26: Pfizer/BioNTech has not yet fully reviewed the complaint but we are surprised by the litigation given the Pfizer/BioNTech Covid-19 Vaccine was based on BioNTech’s proprietary mRNA technology and developed by both BioNTech and Pfizer. We remain confident in our intellectual property supporting the Pfizer/BioNTech vaccine and will vigorously defend against the allegations of the lawsuit.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome