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19 May, 2025 |
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HHS chief Robert F. Kennedy Jr. will face his third congressional budget hearing tomorrow after spending nearly an entire day testifying last week. He likely won’t offer more detail about his planned HHS reorganization with a court order still in place. But we’ll be watching to see what he says about staffing cuts and his next move on the vaccine front. |
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Alexis Kramer |
Editor, Endpoints News
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George Yancopoulos, Regeneron CSO (Brendan McDermid/Reuters/Alamy) |
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by Andrew Dunn
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Regeneron is doubling down on its genetics research ambitions by agreeing to buy most of 23andMe’s business out of bankruptcy. Regeneron is best known for developing blockbuster drugs like
Dupixent and Eylea rather than selling saliva-test kits. The Tarrytown, NY-based biotech has minimal experience, or previously stated interest, in the world of direct-to-consumer healthcare. The agreement includes Regeneron carrying on all consumer genome services uninterrupted, according to the press release. Regeneron’s executives weren’t available for an interview on the deal — at least for now,
as the deal makes its way through the court’s processes. It still needs to be finalized in bankruptcy court, but Regeneron expects to close the $256 million acquisition in the third quarter. |
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by Zachary Brennan
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AbbVie's defense of its megablockbuster Humira may go down in the history books as the poster child for blocking biosimilar competition, but the launch of six Stelara biosimilars this year shows how competitors have learned from that experience. Since launching earlier this year, the six Stelara biosimilars on the market are already gaining
traction against the Johnson & Johnson biologic, which is used to treat a variety of autoimmune diseases and last year sold more than $10 billion. Cigna's private-label distributor Quallent and Optum's private-label distributor Nuvaila are both ready to go with Stelara biosimilar deals made earlier this year, and CVS' subsidiary Cordavis, which cracked AbbVie's hold on Humira, could potentially
follow suit, although the company didn't respond to a request for comment. |
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by Ayisha Sharma
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Boehringer Ingelheim claimed two Phase 3 wins for its PDE4 inhibitor in fibrotic lung diseases, but some Wall Street analysts said the candidate’s “modest” efficacy and limited combination potential could hamper its real-world use in one of the indications. Data presented on nerandomilast for the treatment of idiopathic pulmonary fibrosis showed statistically significant results in two different dosing regimens. The 18 mg dose of the drug achieved an average 68.8 ml difference from placebo in a lung function test called forced vital capacity at 52 weeks, while the 9 mg dose attained a 44.9 ml difference. The German drugmaker on Sunday shared the data from its FIBRONEER-IPF study of nerandomilast at the American Thoracic
Society meeting in San Francisco. The company first revealed the trial met its primary endpoint in September 2024. It has already filed for FDA approval in IPF. |
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by Max Bayer
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After more than a month of waiting and negotiations with US regulators, Novavax has gained FDA approval for its Covid shot. But it’s for a tighter population than the company had asked for, and signals how much harder it may be for vaccine makers to satisfy the agency under Commissioner Marty Makary and HHS Secretary Robert F. Kennedy Jr. The shot was approved for adults 65 and older and for people aged 12 to 64 who have at least one health condition that puts them at increased risk of severe illness from Covid. Novavax played down the tightened population, saying in a statement Sunday that people at higher risk are more likely to seek out vaccination. The FDA's action also triggers a $175 million milestone payment from Sanofi. |
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