Policy & regulation

By Xisca Borrás and Ellie Handy of the life sciences regulatory department at Bristows law firm Femtech, short for female technology, is an important and fast growing sector. The EU is a key market for femtech, with five of the top 10 countries for femtech investment located in the EU. Femtech products are developed for [...]

AbbVie said on Monday that it will launch ovarian cancer drug Elahere in the UK at the same list price as in the US. The announcement follows President Donald Trump’s push for drugmakers to align domestic prices with the lowest levels paid by comparable high-income countries under his “most-favoured-nation” policy. The US currently pays nearly [...]

NHS and private fertility clinics must stop offering unproven add-ons that do not improve chances of conception, new draft guidelines warn. The National Institute for Health and Care Excellence (NICE) advises against several popular fertility extras, including endometrial scratches – where the womb lining is “scratched” before IVF treatment. These procedures can “give false hope [...]

New York attorney general Letitia James will intervene in Texas’s bid to penalise a New York doctor accused of mailing abortion pills across state lines. The Democratic attorney general announced her intervention on Monday, escalating one of the most consequential fights in the US abortion wars since Roe v Wade was overturned three years ago. [...]

Women with polycystic ovarian syndrome face long waits for diagnosis and poor access to treatment, a parliamentary report has warned. More than a third of women with PCOS waited over four years for a diagnosis, according to findings from the all-party parliamentary group. After being diagnosed, 38 per cent said they were not offered any [...]

The US Food and Drug Administration (FDA) has granted fast track status to stenoparib, an ovarian cancer drug for patients who cannot tolerate platinum-based treatments. The designation, given to medicines addressing serious medical needs, allows more frequent FDA communication and may enable accelerated approval if criteria are met. Allarity Therapeutics is developing stenoparib as an [...]

The US decision to incinerate US$9.7m worth of contraceptives is expected to result in 174,000 unintended pregnancies and 56,000 unsafe abortions across five African countries. The medical supplies, many of which were not due to expire until between 2027 and 2029, would have supported more than 1.4 million women and girls in the Democratic Republic [...]

The Trump administration is seeking to ban abortions at Department of Veterans Affairs hospitals, including in cases of rape, incest or where a pregnancy endangers a veteran’s health. Documents filed on Friday propose reversing a Biden-era policy that allowed VA facilities to offer abortion counselling and procedures in limited circumstances to veterans and eligible family [...]

The US Food and Drug Administration has delayed its decision on Bayer’s non-hormonal menopause treatment elinzanetant by up to three months. The agency said it needed more time to complete its review but raised no concerns about the safety or effectiveness of the drug, which is designed to treat moderate to severe hot flushes. Elinzanetant, [...]

China is introducing annual childcare subsidies of 3,600 yuan (US$500) per child under three, as it seeks to counter a continuing drop in birth rates. The national programme, launched this week, is expected to benefit more than 20 million families with toddlers and infants. It will be funded by the central government, with partial support [...]