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Astellas Pharma Inc. | September 05, 2022
Astellas Pharma Inc. announced topline results from the Phase 3 MOONLIGHT 3™ clinical trial in women in mainland China evaluating the long-term safety and tolerability of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms associated with menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.
MOONLIGHT 3 is a 52-week single-arm Phase 3 clinical trial ...
GlaxoSmithKline | August 07, 2020
Back in 2015, GlaxoSmithKline traded away its marketed cancer assets and began building its oncology pipeline “pretty aggressively,” as Axel Hoos, the company’s SVP of Oncology R&D, puts it. Those efforts have finally paid off with a new approval. But just how much remains to be seen, with analysts expecting "limited adoption" for the company's newcomer thanks to a Black Box warning for eye toxicity. The FDA late Wednesday green-lighted Blenrep—formerly ...
NRx Pharmaceuticals | August 26, 2021
NRx Pharmaceuticals announced today it has signed an agreement with Cardinal Health to provide third party logistics and distribution of ZYESAMI™ upon the potential Emergency Use Authorization (EUA) approval by the US Food and Drug Administration (FDA). In May, NRx submitted an application for EUA to the FDA for ZYESAMI™ (aviptadil) for patients suffering from Critical COVID-19 with respiratory failure.
"This partnership creates an efficient and highly flexible lo...
Thermo Fisher | October 15, 2020
Thermo Fisher Scientific announced the launch of its Gibco CTS Rotea Counterflow Centrifugation System, a modular, closed cell therapy processing system that enables scalable, cost-effective cell therapy development and manufacturing. The CTS Rotea system is the first Gibco instrument for cell therapy processing applications and facilitates workflows from research through GMP clinical development and commercial manufacturing. As of mid-2020, 675 clinical trials were underway globally for cell th...
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