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In the NDA, OPKO seeks approval of Rayaldee for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD)

Under terms of the agreement, Merck, through a subsidiary, will acquire all outstanding stock of cCAM in exchange for an upfront payment of $95 million in cash. In

As part of the agreement, the two companies will jointly develop a programmed cell death protein 1 (PD-1) inhibitor currently in Phase 1 testing and plan to initiate

The company noted that anti-RSPO3 is the first drug in its class to target the R-spondin-LGR pathway, an important cancer stem cell pathway identified by OncoMed researchers. In

Currently, Azedra is being evaluated in a pivotal Phase IIb trial, which is being conducted under a Special Protocol Assessment Agreement (SPA), and has received orphan drug and

Reslizumab is designed to treat inadequately controlled asthma in adult patients with elevated blood eosinophils, despite an inhaled corticosteroid (ICS)-based regimen. The MAA is based on data from

In December 2014, the company completed a Phase III actual use trial, which was intended to simulate the OTC use of Lipitor (atorvastatin calcium) 10mg. The program was

HM61713 is a new 3rd generation, orally active, irreversible EGFR mutation selective tyrosine kinase inhibitor (TKI). As part of the deal, Hanmi will receive an initial payment of

The deal will combine the institute’s clinical expertise and data with Biogen’s focus on neurodegenerative disease and approach to clinical development. Biogen chief scientific officer Spyros Artavanis-Tsakonas said: