The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA
Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.
Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma
Phase 1 dose-escalation study to be conducted at clinical sites in the U.S., the UK, Australia, and the Philippines
The integrated services ensure that NextPoint can bring their molecule to the clinic in a timely manner.
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
Collaboration supports multiple discovery efforts, including vaccines
QIAstat-Dx Viral Vesicular Panel tests for six pathogens that produce similar symptoms
Collaboration focuses on developing and implementing real-world research to drive patient access to cancer medicines
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