The NDA is based on results from the Phase II ACE-LY-004 clinical trial, which evaluated the safety and efficacy of acalabrutinib in patients with relapsed/refractory mantle cell lymphoma
The submission includes analytical, pharmacokinetic and clinical data, and pharmacology and toxicology data. Amgen said that both companies are collaborating on four oncology biosimilar medicines, including ABP 980. The
The COMMEND trial will evaluate FLX-787, the Company’s co-activator of TRPA1 and TRPV1, in patients with motor neuron disease (MND), focused on ALS, who suffer from painful, debilitating
The study will evaluate preliminary safety and efficacy of the combination in a Phase II trial. The combination of AE37 plus KEYTRUDA follows previous studies, in which both
This application represents the first chimeric antigen receptor (CAR) T-cell therapy submitted to the EMA. Axicabtagene ciloleucel is currently under review by the U.S. Food and Drug Administration
GC4419 is a novel dismutase mimetic designed to prevent the damaging effects of radiation in normal tissue by rapidly converting superoxide to hydrogen peroxide, and is currently in
Adapalene and benzoyl peroxide gel 0.1%/2.5% is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris in patients
Under the agreement, Evotec will pay $300m in cash, which will be financed through a mix of existing cash reserves and an additional EUR140m senior debt facility. The
The focus will be on a range of newly discovered RNA modulating enzyme targets. Evotec and STORM have been collaborating since 2016 in high-throughput screening and structural biology
In its letter to Eagle, the FDA has requested that the Company conduct an additional clinical trial for RYANODEX for Exertional Heat Stroke. “We are reviewing our options
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