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5 December, 2025 |
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Max Bayer has been watching (and for better or worse, live-tweeting) ACIP's consideration of the hepatitis B birth dose, as well as the committee's broad debates about US vaccine policy. You can read his full story on the vote below. |
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Drew Armstrong |
Executive Editor, Endpoints News
@ArmstrongDrew
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The ACIP panel votes on hepatitis B vaccine policy at the CDC headquarters on Dec. 5, 2025 (Ben Gray/AP Images) |
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by Max Bayer
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A panel of CDC vaccine advisors has stopped recommending that all children receive the hepatitis B vaccine at birth, overruling scientific consensus and public health officials who pleaded that there was no grounded rationale for the move. The majority of members of the Advisory Committee on Immunization
Practices voted on Friday that pregnant women who test negative for hepatitis B should consult a healthcare provider before giving their newborn a shot. Eight members voted in favor of the change and three voted against it. The recommendation stops short of explicitly recommending that some children not receive the birth dose, instead putting the decision on individuals. The committee also voted to recommend that
parents consult a healthcare provider to see if a child should get tested for their antibody levels against hepatitis B before receiving additional doses in the vaccination series. | |
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by Nicole DeFeudis
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Bristol Myers Squibb’s CAR-T therapy Breyanzi has become the first such treatment approved for patients with a rare, slow-growing type of non-Hodgkin lymphoma. The drug was approved Thursday for third-line patients with marginal zone lymphoma, which occurs when white blood cells clump together and form lumps in lymph nodes or organs. Patients with marginal zone lymphoma
often achieve remission after initial treatment — but many relapse. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, said in a news release that the approval “represents a major advancement in precision medicine.” Lynelle Hoch, president of Bristol Myers’ cell therapy unit, championed the breadth of
Breyanzi’s label in a separate announcement. The new indication is Breyanzi’s fifth cancer approval, covering what Hoch called “the broadest range of B-cell malignancies,” compared with other CAR-Ts. | |
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by Tom Randall
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Inside the two-week stretch that marked a reversal in biopharma sentiment. During the two weeks that our biopharma sentiment survey was in the field in mid-October, something unusual happened: The mood of the industry appeared to snap out of its despair. Endpoints Signal surveyed more
than 1,400 people for the Biopharma Sentiment Index (BPSI) over that time. Coming into the story, many were still thinking about 2025 as another grind-it-out down year. At the start of our survey, the sentiment reading hovered around 70, far below the neutral baseline of 100. But over the next several weeks, while the survey was in the field, there was a sharp and consistent upturn toward a much less negative viewpoint.
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by Kyle LaHucik
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A new biotech has raised $100 million to build a mix of assets from inside and outside China, while developing its own drug candidates. The Shanghai-based startup, called OTR Therapeutics, is a new twist on Western investors that build new companies around Chinese drug candidates. The company wants to take advantage of the rapid development and
clinical work available in the region, but with assets that can come from anywhere. That approach has attracted a group of global backers, including Pfizer Ventures, Lilly Asia Ventures, Temasek, True Light Capital and Sirona Capital. OTR has already acquired a preclinical neurology drug candidate from an unnamed Chinese biotech, CEO Zhui Chen said in a Friday morning interview. And it's in late-stage discussions about two or three other assets to bring in. | |
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by Anna Brown
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The UK’s National Institute for Health and Care Excellence (NICE) told stakeholders this week that previously rejected drugs won’t automatically fall under its new cost-effectiveness threshold. Further, medicines currently under review that would now be covered by the new £35,000 limit will have their decisions
delayed until April, according to a Thursday email seen by Endpoints News. After ongoing negotiations with the US government, the UK announced last week it was raising its cost-effectiveness threshold for drugs by 25%. Currently, the upper threshold limit is £30,000, but this will be raised to £35,000, meaning an additional three to five drugs or label expansions will be recommended per year. It’s currently unclear which drugs would benefit from this future update, but meetings are expected to be set after April. | |
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