Ascletis is China's first biotech company which has obtained IND approvals of an oral RdRp inhibitor from both China NMPA and the U.S. FDA
Phase 1 dose-escalation study to be conducted at clinical sites in the U.S., the UK, Australia, and the Philippines
DEP® ADCs exploit the unique potential of Starpharma's DEP® technology to provide enhanced characteristics to ADCs i
This biopharmaceutical facility is one most significant private sector investment ever in the Middletown region
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma
Genentech will be granted an exclusive license to develop and commercialize the degrader worldwide, and will be fully responsible for the development and commercialization costs.
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 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 integrated services ensure that NextPoint can bring their molecule to the clinic in a timely manner.
The decision is based on the outcome of a prespecified interim analysis of the Phase 3 AMEERA-5 trial
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