相关临床试验
1
0 进行中
药物批准
19
批准总数
监管机构
1
监管机构数
成立时间
1954
已完成
1
100.0%
- The Scottish Medicines Consortium has approved linzagolix with add-back therapy as a new treatment option for adult women with endometriosis who have previously undergone medical or surgical treatment. - The approval aligns NHS Scotland with the rest of the UK, where linzagolix has already been approved by NICE for use in England, Wales and Northern Ireland. - Linzagolix is a once-daily GnRH receptor antagonist that works by suppressing estrogen and has shown statistically significant reduction in painful periods and pelvic pain in clinical trials. - The drug affects approximately one in ten women of reproductive age in the UK who suffer from endometriosis, a condition causing chronic pelvic pain and significant quality of life impacts.
- Gedeon Richter UK has launched Nalvee (10mg dydrogesterone), marking the return of a dydrogesterone-only hormone replacement therapy formulation after more than 17 years of absence from the UK market. - The oral tablet offers clinicians a new progestogen option for non-hysterectomised women receiving oestrogen therapy, with clinical studies showing 97% success in endometrial protection. - Dydrogesterone closely mimics natural progesterone with high bioavailability and specificity for progesterone receptors, allowing efficacy at doses 10 to 20 times lower than micronised progesterone. - The treatment addresses a significant gap in HRT options by providing predictable, lighter bleeding patterns that may enhance patient satisfaction and reduce discontinuation rates.
- The Scottish Medicines Consortium has recommended Theramex's Eladynos (abaloparatide) for treating osteoporosis in postmenopausal women at very high risk of fracture through NHS Scotland. - Over 1,000 postmenopausal women in Scotland are expected to benefit from this anabolic therapy, which promotes new bone formation through daily injections for up to 18 months. - Hip fractures cost the NHS £2 billion annually, with total osteoporotic fracture costs exceeding £4.6 billion and projected to reach £6 billion by 2030. - The approval follows NICE's previous recommendation in August 2024 for England, Wales, and Northern Ireland, ensuring equitable access across the UK.
- Daré Bioscience and Theramex have entered into a co-development agreement for Casea S, a first-in-category biodegradable contraceptive implant designed to last 18-24 months. - The innovative implant eliminates the need for surgical removal, addressing a key barrier in current contraceptive implants while offering women a convenient, long-acting contraceptive option. - A foundation-funded Phase 1 trial is currently underway to evaluate the pharmacokinetics, removability, safety, and tolerability of Casea S.
- Linzagolix (Yselty), a GnRH antagonist developed by Kissei, has been approved by the European Commission for treating endometriosis. - This approval expands Yselty's indication, which is already available in five European countries for uterine fibroids. - Linzagolix works by reducing estrogen production in the ovaries, addressing a key factor in endometriosis. - Kissei is also developing linzagolix for uterine fibroids and endometriosis in Japan, with plans to seek approval.
- Theramex has launched Yselty (linzagolix), a GnRH receptor antagonist developed by Kissei, in Germany for treating moderate to severe uterine fibroids. - Yselty is approved in Europe and the UK for adult women of reproductive age, offering a new option for those who cannot take hormonal agents. - Clinical trials confirmed Yselty's efficacy both with and without add-back therapy, improving bleeding and pain symptoms associated with uterine fibroids. - Kissei has out-licensed linzagolix development to multiple companies, with ongoing Phase III trials in Japan for uterine fibroids and Phase II trials for endometriosis.
- NICE has approved Eladynos (abaloparatide) for routine NHS use in postmenopausal women at high risk of osteoporotic fractures, potentially benefiting 14,000 patients in England. - The drug represents only the second osteoporosis treatment to reach UK patients in 15 years, offering an alternative to existing therapies Evenity and Forsteo. - Despite the approval, limited access to Fracture Liaison Services in half of NHS Trusts may prevent 90,000 patients from receiving new bone treatments like Eladynos.
