The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma
The product will be manufactured at Lupin's facility in Goa, India.
The decision follows authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022.
Phase 1 dose-escalation study to be conducted at clinical sites in the U.S., the UK, Australia, and the Philippines
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 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
First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations
Collaboration supports multiple discovery efforts, including vaccines
The Trial, the first of its kind in Israel, recently obtained approval from the Israeli Ministry of Health and is preparing for participant recruitment.
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