GlobalData’s ‘Pharmaceutical Intelligence Center’ observes that India is still in the nascent stage of developing these potential therapies as currently only four cell/gene therapy molecules are being developed in the country.
The decision follows authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022.
The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
The decision is based on the outcome of a prespecified interim analysis of the Phase 3 AMEERA-5 trial
Results consistent with previous trials, reinforcing benefit of Daiichi Sankyo and AstraZeneca’s ENHERTU in previously treated patients
Urged stakeholders to come up with similar digital platforms and create homegrown best practices where Indian methods and Indian solutions dominate the digital spaces
AI-driven company anumana partnered with Novartis to drive the development of its electrocardiogram (ECG) AI algorithms to detect subclinical heart disease.
The inspection concluded with four Form 483 observations. None of the observations were related to data integrity.
Patritumab deruxtecan is a specifically designed potential first-in-class HER3 directed antibody drug conjugate (ADC) discovered and being developed by Daiichi Sankyo.
The safety profile of KEYTRUDA plus LENVIMA was consistent with previously reported data on the combination.
Subscribe To Our Newsletter & Stay Updated
