Laboratoire Theramex

Daré Bioscience Fast-Tracks Sildenafil Cream Launch with Dual-Market Strategy for Women's Health

a month ago

• Daré Bioscience has unveiled a dual-path approach to make its proprietary Sildenafil Cream formulation available via prescription by Q4 2025, responding to healthcare community urging and women's demand. • The company is exploring a 503B compounding pathway to accelerate market access for its female sexual arousal disorder (FSAD) treatment, potentially creating the first FDA-approved therapy for this condition. • CEO Sabrina Martucci Johnson will present the expanded business strategy at the Jones Healthcare and Technology Innovation Conference, with plans to evaluate similar approaches for other proprietary formulations in their portfolio.

New Endometriosis Pill Ryeqo Approved for NHS Use, Offering Hope to 1.5 Million UK Sufferers

2 months ago

• A first-of-its-kind daily pill for endometriosis, relugolix combination therapy (Ryeqo), has been approved for NHS use in England after initially being rejected by Nice. • The breakthrough treatment works by blocking hormones that contribute to endometriosis while providing hormone replacement, offering a more convenient alternative to injectable treatments for approximately 1,000 patients annually. • Endometriosis affects 1.5 million women in the UK, causing debilitating pain and fertility issues, with diagnosis typically taking nine years from symptom onset.

Daré Bioscience and Theramex Partner to Develop Novel Biodegradable Contraceptive Implant

3 months ago

• 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.

Teriparatide Biosimilar RGB-10 Demonstrates Equivalent Efficacy to Reference Drug in High-Risk Osteoporosis Patients

3 months ago

• Real-world study confirms RGB-10, a teriparatide biosimilar, shows comparable bone density improvements to reference teriparatide in postmenopausal women with high fracture risk osteoporosis. • Both treatments demonstrated significant improvements in lumbar spine bone mineral density over 24 months, with no statistical differences between groups across multiple measurement parameters. • The study validates RGB-10 as a viable therapeutic alternative for high-risk osteoporosis patients, supporting its potential role in expanding treatment accessibility.

Linzagolix (Yselty) Receives European Commission Approval for Endometriosis

5 months ago

• 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 Launches Linzagolix (Yselty) for Uterine Fibroids in Europe

8 months ago

• 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 Approves Eladynos for Postmenopausal Osteoporosis, But NHS Diagnostic Gaps Pose Access Challenges

10 months ago

• 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.