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TherapeuticsMD's Hormone Therapy Approved in U.K. and Belgium

TherapeuticsMD, a women’s healthcare company, received approval for its Bijuva hormone replacement therapy in the U.K. and Belgium.
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TherapeuticsMD  (TXMD) - Get TherapeuticsMD Inc. Report shares rose sharply Friday after the women’s healthcare company announced that its Bijuva hormone replacement therapy (HRT) gained approval in the U.K. and Belgium.

TherapeuticsMD has a license and supply agreement with privately-held pharmaceutical company Theramex to commercialize Bijuva outside the U.S., Canada and Israel. Theramex said it expects approvals from other major EU countries soon.

Bijuva is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.

“Bijuva is the first and only oral combined HRT with bio-identical hormones,” the companies said. “Bio-identical hormones are hormones that are structurally identical to the hormones your body produces naturally. It is not known if there is a difference in risks between synthetic hormones and bio-identical hormones.”

TXMD traded up 6.06% to $1.40 in pre-market trading Friday, but has dropped 20% over the past six months.

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“We are excited to bring this first and only combination of micronized progesterone and estradiol to the U.K. and Belgium through our license agreement with TherapeuticsMD,” said Robert Stewart, chief executive of Theramex.

In other major drug news this week, the European Medicines Agency said AstraZeneca’s COVID vaccine is likely causing deadly blood clots in a small number of vaccinated people.

The agency said people should still get vaccinated for the coronavirus, but doctors must pay attention to the problem.

And the U.K. government Wednesday recommended against giving the AstraZeneca vaccine to adults under 30 because of the blood-clot issue.

Meanwhile, Oxford University paused a study of the drugmaker's COVID-19 vaccine in children until the British regulator completes a review of rare cases of blood clotting.