China’s National Medical Products Administration (NMPA) on June 4 granted conditional approvals to two oncology drugs from Lupeng Pharmaceutical Co. Ltd. and Vcare Pharmatech Co. Ltd., as well as one hemophilia drug developed by Staidson Biopharmaceutical Co. Ltd.
Grace Therapeutics Inc.’s hopes of becoming the first company in decades to update the standard of care in aneurysmal subarachnoid hemorrhage were delayed after the U.S. FDA issued a complete response letter (CRL) for its GTx-104 NDA, citing manufacturing and nonclinical deficiencies rather than concerns over efficacy or safety.
The U.S. FDA’s recent pledge to make public complete response letters (CRLs) for drugs and biologics that failed to gain approval has encountered some objections from industry regarding the potential for disclosure of trade secrets and proprietary information.
