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Bhattacharya-Makary

Just one more vote to go for FDA, NIH nominees

March 13, 2025
By Mari Serebrov
As expected, the U.S. Senate Health, Education, Labor and Pensions Committee voted March 13 to send the nominations of Jay Bhattacharya as NIH director and Martin Makary as FDA commissioner to the Senate floor for confirmation. Bhattacharya received a narrow 12-11 party-line vote, but Makary picked up some Democratic support to secure a 14-9 vote.
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CDC headquarters

US CDC nomination withdrawn, reforms in the works

March 13, 2025
By Mari Serebrov
Shortly before the Senate Health, Education, Labor and Pensions Committee was to hold the first ever confirmation hearing for a U.S. CDC director March 13, it issued a statement saying the hearing was canceled due to the White House withdrawing its nomination of Dave Weldon, a physician and former congressman from Florida.
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FDA icons and doctor

AMP says FDA asks too much of test validation in Section 564 draft

March 13, 2025
By Mark McCarty
The U.S. FDA’s January 2025 draft guidance for test validation in public health emergencies drew only six responses, but pointed responses they were, indeed. As an example, the Association for Molecular Pathology (AMP) said the draft’s recommendation for the use of 30 positive and 30 negative (30/30) samples for validation of lab-developed tests is likely to hamper test availability in an emergent situation, a time when samples are likely to be difficult to obtain.
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Document illustration

US NIH grant peer review to get a bit of a makeover

March 12, 2025
By Mari Serebrov
Looking to shave $65 million from its annual expenditures while streamlining the first stage of its two-level grant review process, the U.S. NIH is proposing to centralize the peer review of all applications for grants, cooperative agreements and R&D contracts within its Center for Scientific Review.
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Vaccine vial and syringe

Aim seeks approval of first serum-free human rabies vaccine

March 12, 2025
By Marian (YoonJee) Chu
Aim Vaccine Co. Ltd. may become the first company to gain regulatory clearance of a prophylactic iterative serum-free human rabies vaccine. Beijing-based Aim said it is preparing a regulatory submission of its independently developed rabies vaccine based on positive phase III results that showed good safety, immunogenicity and immune persistence.
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Celltrion wins FDA approval of denosumab, omalizumab biosimilars

March 12, 2025
By Marian (YoonJee) Chu
Celltrion Inc. is on a biosimilar roll with the U.S. FDA this month, having gained clearance of Stoboclo and Osenvelt as products referencing Amgen Inc.’s biologic, denosumab (Prolia, Xgeva), along with Omlyclo becoming the first and only interchangeable biosimilar to omalizumab (Xolair, Genentech Inc. and Novartis AG).
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Hospital patient wearing pulse oximeter

ISO, IEC advise against simplistic approaches to pulse ox performance

March 12, 2025
By Mark McCarty
The U.S. FDA’s latest draft guidance on pulse oximeters drew comment from the International Standards Organization and the International Electrotechnical Commission, which are making the case that in addition to differences in pigmentation, the pulsatility of the tissue in contact with the device is also a factor in device performance.
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Lungs and bronchiole

CMS eyes ventilation coverage for beneficiaries with COPD

March 12, 2025
By Mark McCarty
Medicare beneficiaries in the U.S. diagnosed with chronic obstructive pulmonary disease (COPD) may soon be covered for positive pressure ventilation in the home per a draft coverage memo from CMS.
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3D rendering of skin cells and elastin with collagen layer
Dermatologic

Sagimet’s FASN inhibitor cleared to enter clinic for acne

March 12, 2025
Sagimet Biosciences Inc. has obtained IND clearance from the FDA for TVB-3567 (ASC-60), a selective small-molecule fatty acid synthase (FASN) inhibitor set to enter clinical development for the treatment of acne. A first-in-human phase I trial of TVB-3567 in individuals with or without acne is expected to begin this year.
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Pharmaceutical manufacturing

As tariffs threaten US imports of APIs, companies reshore manufacturing

March 11, 2025
By Marian (YoonJee) Chu
While the U.S. has historically led the global pharmaceutical industry by pursuing both continual innovation and high quality, those strengths could become areas of weakness in times of political uncertainty, according to PA Consulting expert Andy Prinz.
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