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.
OrderPoint was designed as an advanced DTR solution from its first release in 2016.
Phase 1 dose-escalation study to be conducted at clinical sites in the U.S., the UK, Australia, and the Philippines
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.
According to industry sales data, Yondelis generated annual sales of $49.7 million for the twelve months ending June 2022 in the US market.
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
The Supervisory Board has unanimously decided to propose Roy Jakobs as the next President and CEO of Royal Philips to its General Meeting of Shareholders.
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