Plus: FDA extends etonogestrel implant use to 5 years, Novo Nordisk licenses PharmaShell technology, and Kaiser Family Foundation publishes abortion data.
Heidi Overton, President Trump's nominee to lead the Food and Drug Administration, avoided answering questions from senators during her confirmation hearing, particularly on the abortion drug mifepristone, observed by Senator Chris Murphy. This comes as the FDA also approved extending etonogestrel implant use to 5 years, requiring new clinician REMS certification. Meanwhile, Novo Nordisk licensed Nanexa's PharmaShell technology for long-acting drug delivery, potentially impacting areas like contraception. Five takes inside, plus a quick-hits roundup.
VIA STAT News
Novo Nordisk will pay up to $1.3 billion to license Nanexa’s PharmaShell technology, targeting monthly and quarterly drug administration. The exclusive deal covers up to five development programs. This technology aims to reduce the injection frequency for patients using obesity and diabetes drugs by enabling controlled, sustained release of active ingredients. For femtech operators, this highlights the growing interest in long-acting drug delivery systems for chronic conditions, which could translate to areas like contraception or hormone therapy.
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— The Luteal Editorial Team
VIA STAT News
President Trump nominated Heidi Overton, a preventive medicine physician, to lead the Food and Drug Administration. Overton worked in the White House during both Trump terms. During her hearing, Overton referred repeatedly to existing agency guidance and approvals for products like childhood vaccines and the abortion drug mifepristone. Senator Chris Murphy (D-Conn.) observed that Overton avoided answering questions.
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— The Luteal Editorial Team
VIA Contemporary OB/GYN
The FDA approved extending etonogestrel implant use to 5 years. Clinicians must complete a new REMS certification by February 23, 2027. This regulatory update affects providers and manufacturers of the etonogestrel implant.
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— The Luteal Editorial Team
VIA Kaiser Family Foundation Women's Health
This issue brief presents data about abortion in the United States. It includes data collected before and new data published since the overturn of Roe v. Wade.
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— The Luteal Editorial Team
VIA STAT News
The Senate health committee met with Heidi Overton, nominee for Food and Drug Administration commissioner. Overton, when questioned on mifepristone, a key abortion medication, did not directly address her views. The CEO of Reproductive Futures, a legal organization advocating for reproductive rights, expressed concern regarding Overton's clear anti-abortion views and potential to cause harm as FDA commissioner.
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— The Luteal Editorial Team