Zydus Lifesciences Ltd.

Zydus Launches ANVIMO: Game-Changing CMV Prevention Drug for Transplant Patients at 91% Lower Cost

3 months ago

• Zydus Lifesciences introduces ANVIMO (letermovir) in India, offering a breakthrough treatment for preventing Cytomegalovirus infection in stem cell and kidney transplant patients. • The new drug demonstrates superior safety profile and reduced side effects compared to traditional treatments, while maintaining bioequivalence with the reference drug. • ANVIMO's launch dramatically reduces treatment costs by 91% compared to imported alternatives, making critical CMV prophylaxis more accessible to Indian transplant patients.

FDA Grants Priority Review to CUTX-101 for Menkes Disease, Offering Hope for Rare Pediatric Condition

5 months ago

• The FDA has accepted Sentynl Therapeutics' NDA for CUTX-101, granting priority review for the treatment of Menkes disease, a rare genetic disorder. • Clinical trials of CUTX-101 demonstrated an almost 80% reduction in mortality risk compared to untreated patients, significantly improving overall survival. • CUTX-101 has been granted multiple designations, including Breakthrough Therapy and Orphan Drug, highlighting its potential to address a critical unmet need. • Cyprium Therapeutics is eligible to receive up to $129 million in milestone payments and royalties, retaining ownership of a potential Priority Review Voucher.

Zydus Lifesciences Gains USFDA Approval for Enzalutamide Formulations

8 months ago

• Zydus Lifesciences has received USFDA approval for Enzalutamide capsules (40 mg) for metastatic castration-resistant prostate cancer. • The company also received tentative approval for Enzalutamide tablets (40 mg and 80 mg) for castration-resistant and metastatic castration-sensitive prostate cancer. • These approvals mark Zydus's 400th approval, with over 465 ANDAs filed since FY 2003-04, strengthening its oncology portfolio. • The approved drugs will be manufactured at Zydus's facilities in Moraiya and SEZ, Ahmedabad, with significant market potential in the US.