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15 August, 2025 |
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Vinay Prasad’s FDA profile page is back up today, about a week after he made his return to the agency. It appears that he still has all three of his titles. Prasad also made a statement yesterday about the new approval of Precigen’s rare disease therapy,
Papzimeos. |
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Alexis Kramer |
Editor, Endpoints News
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HHS Secretary Robert F. Kennedy, Jr. (George Walker IV/AP Images) |
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by Max Bayer
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HHS Secretary Robert F. Kennedy Jr. on Friday shut down rumors that he was in the early stages of another presidential campaign, writing on social media that "I am not running for president in 2028." He also defended a top aide who was facing mounting criticism from allies of President Donald Trump. Kennedy's post on X aimed to address recent media reports about his political ambitions and alleged dysfunction at the top of the agency he oversees. News reports have speculated on a looming run for a few weeks, after Axios in July
reported on an organizing call led by a political action committee behind Kennedy's Make America Healthy Again movement. Kennedy on Friday accused “DC lobbying shops” of “pushing the flat-out lie” that he was working on another presidential campaign. Kennedy ran in 2024 as an independent before dropping out and backing Trump. |
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by Nicole DeFeudis
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A sickle cell candidate from Pfizer’s $5.4 billion acquisition of Global Blood Therapeutics failed a Phase 3 study, the pharma giant announced on Friday. Inclacumab didn’t significantly
reduce the rate of painful complications called vaso-occlusive crises compared to placebo in patients 16 years and older, missing the trial’s primary endpoint. The study was one of two late-stage trials in Pfizer’s THRIVE program testing inclacumab for those complications. Pfizer terminated the other trial last year due to slow enrollment. Patients in the completed trial were given
inclacumab every 12 weeks over 48 weeks. Pfizer said the drug was “generally well-tolerated.” A Pfizer spokesperson told Endpoints News that the company is continuing to review the data and “will provide updates on our next steps as appropriate.” |
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by Alex Hoffman, Kathy Wong, Kyle LaHucik
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→ Former FDA Commissioner Stephen Hahn has handed the reins to board member Ajit Singh at Flagship’s early cancer detection biotech Harbinger Health. Hahn was named CEO of Harbinger in December 2021 and will be “CEO emeritus and special advisor,” the company said in a release. He will stay on the board of directors. During his two decades with Siemens, Singh was president and CEO of the digital radiology and medical informatics business, as well as president and CEO for the oncology care systems group. He then became CEO of BioImagene, a digital pathology company that he sold to Roche. Since 2011, Singh had been a partner/managing director at Artiman Ventures. |
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by Elizabeth Cairns
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Summit Therapeutics licensed its PD-1xVEGF bispecific antibody ivonescimab from the Chinese company Akeso back in 2022. But analysts believe that the US biotech needs to find another, even bigger partner to bring the cancer drug to market. Any list of potential allies is unlikely to include Bristol Myers Squibb, Pfizer and Merck, which
have all already paid big money for the rights to their respective VEGF bispecifics. So, which companies might buy into this area by snapping up the rights to ivonescimab? Endpoints News listened to several biopharma earnings calls and combed through AlphaSense transcripts to find some clues. A putative collaborator would likely already have a portfolio of cancer products. One goal of a
partnership would be to combine ivonescimab with other mechanisms to create even more effective therapies. |
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by Lei Lei Wu
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The FDA granted an unexpected full approval to Precigen's treatment for a rare disease caused by human papillomavirus, or HPV. Thursday's decision also came earlier than anticipated, at a time when the agency’s handling of rare disease therapies is under scrutiny. Known as
zopapogene imadenovec, the treatment is an immunotherapy that will be marketed as Papzimeos. The therapy was approved to treat adults with recurrent respiratory papillomatosis, which are wart-like growths on or around the vocal cords that return even after they are removed. The disease is caused by infection with chronic HPV 6 or 11, and is estimated to affect around 27,000 adults in the US. A spokesperson said the price of
Papzimeos would be disclosed during Monday's investor call. |
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