|
|
|
M T Wed Th F |
23 April, 2025 |
|
|
|
|
|
|
Novavax finally heard back from the FDA on its Covid-19 vaccine. The review deadline came and went several weeks ago, and now Novavax says the agency has asked it to commit to producing post-marketing data. Max Bayer has the details. |
|
Alexis Kramer |
Editor, Endpoints News
|
|
|
|
|
by Max Bayer
|
WASHINGTON — Representatives from large vaccine makers say they are committed to their pipelines, despite a new wave of scrutiny in the US that risks diminishing a major market. On a panel at the World Vaccine Congress this week, executives from Merck, Moderna, Pfizer, Sanofi and GSK stood by their clinical-stage
efforts and said they'll continue to invest in vaccines. “We’re in this for the long game,” Sally Mossman, Sanofi's VP and head of research portfolio strategy, said Tuesday. “We believe in vaccines, and the value of vaccines and what they bring to public health." Alejandra Gurtman, Pfizer’s senior vice president of vaccines clinical research and development, said “we will always stand behind the science and what has taken us here.” |
|
|
|
|
by Zachary Brennan
|
Pfizer, Novartis, Amgen, Eli Lilly and Johnson & Johnson were the top congressional lobbying spenders among the major biopharma companies, as the industry faces a tumultuous environment in which the Trump administration has made huge changes to trade, regulatory and science policy. Pharma tariffs, PBM reforms,
the Inflation Reduction Act, restoring the orphan drug tax credit and onshoring pharmaceuticals were all cited as issues by pharma companies in the latest round of quarterly lobbying disclosures by Congress. Indianapolis-based Lilly, for example, spent $3.4 million on lobbying in the first quarter of this year — roughly double its spending from the first quarter of 2024. The company said its lobbying was
focused on tariffs, IP protection, and trade-related talks with China, the EU, India and others. |
|
|
|
|
by Max Bayer
|
The FDA has asked Novavax to commit to producing post-marketing data of its Covid vaccine, the clearest example yet that the goalposts have changed for vaccine makers under HHS Secretary Robert F. Kennedy Jr.’s leadership. The company said in a Wednesday statement that it “recently received formal communication from the FDA in the form
of an information request for a post marketing commitment (PMC) to generate additional clinical data.” “We look forward to engaging with the FDA expeditiously to address the PMC request and move to approval as soon as possible,” the company said. HHS spokesperson Andrew Nixon said in a statement that "HHS remains committed to our promise: ensuring products are safe for the American people and grounded in gold-standard science." |
|
|
|
|
 |
AstraZeneca CEO Pascal Soriot in London in 2023 (Justin Tallis/Press Association via AP Images) |
|
by Nicole DeFeudis
|
AstraZeneca CEO Pascal Soriot called on Europe to step up investments and “protect its health sovereignty" as it falls behind the US on spending. His comments echo calls from other pharma CEOs who are saying that Europe needs to better incentivize innovation. Multiple drug companies have made recent multibillion-dollar
commitments to boost their capabilities in the US. “The world order is shifting right now and Europe needs to invest more in what really matters to it," Soriot said in a statement sent to Endpoints News on Wednesday. “Europe spends a substantially lower share of GDP on innovative medicines than the US and, as a result, is falling behind in attracting R&D and manufacturing investments, putting its ability to protect the health of its own people at risk." |
|
|
|
|
by Shelby Livingston
|
Just a few weeks after Eli Lilly sued two large compounding pharmacies, the pharma giant on Wednesday filed lawsuits against four telehealth companies over their sale of compounded versions of the GLP-1 obesity drug tirzepatide. In four separate complaints, Lilly alleged that the telehealth companies deceive customers and make false claims about their compounded tirzepatide drugs, including that the medications are safe and effective and person& |
|
|