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Beyond Hormone Therapy: Signs Of Life In Pipeline For Menopausal Women

 
• By Bridget Silverman

Conditions associated with menopause represent a huge market, yet the R&D pipeline has long been slim, despite the well-known drawbacks of marketed hormone replacement therapies. But new approaches with a tissue-selective estrogenic effect are emerging: Shionogi’s Osphena for menopause-related sexual dysfunction broke the long drought in NME approvals, and Pfizer’s broad NDA for bazedoxifene/conjugated estrogens is under review. Emerging companies like EndoCeutics are exploring new hormonal approaches.

The potential market may be huge, but advances in pharmacotherapy for conditions associated with menopause have been few in recent years – rocked by the safety issues uncovered by the Women’s Health Initiative and with disappointing results out of the major class in development. But a new crop of more selective and non-hormonal agents shows that it might again become a profitable sector.

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• By Vibha Sharma

The European Medicines Agency has launched a phased initiative to consolidate the wide array of training materials for the Clinical Trials Information System, aiming to eliminate duplication, ensure consistency, improve accessibility and enhance user-friendliness.

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• By Anju Ghangurde

India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.

HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By Vibha Sharma

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.