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eDeviation | April 21, 2021
Ethical GmbH, a Swiss organization that provides personalized software solutions for clinical research committee management, has created a new software solution to help with protocol deviation (PD) evaluation and management.
The new eDeviation® solution will allow clinical trial sponsors, CROs, and EC/IRBs to handle all protocol deviations in a single repository, assess them electronically in a blinded or unblinded manner, and track all operations.
FiercePharma | February 07, 2020
It wasn’t long ago when Seattle Genetics shareholders moved past earlier letdowns and cheered strong performance from key cancer drug Adcetris. But now, they might be disappointed again. During the fourth quarter, Adcetris pulled in sales of $166.2 million in the U.S. and Canada, a 26% increase over 2018. Still, the number came below the Street’s expectations of $174.5 million as well as its own third-quarter sales of $167.6 million. The fourth-quarter haul brought the antibody-drug ...
Biohaven Pharmaceutical Holding Company Ltd. | October 14, 2020
Biohaven Pharmaceutical Holding Company Ltd. today announced that the U.S. Food and Drug Administration (FDA) has filed and accepted for review its recently submitted supplemental New Drug Application (sNDA) for NURTEC™ ODT (rimegepant) for the preventive treatment of migraine. The Prescription Drug User Fee Act (PDUFA) goal date for completion of the FDA review of the preventive sNDA is set for 2Q2021. Vlad Coric, M.D., Chief Executive Officer of Biohaven commented, "Patients with mi...
WRAL TechWire | February 11, 2020
Mycovia Pharmaceuticals, a developer of drugs in women’s health, has initiated “extension studies” as part of its ongoing Phase 3 global clinical trial of its lead drug candidate for treating recurrent yeast infections in women. The Durham-based firm is developing oteseconazole (VT-1161), an oral antifungal product candidate, for the treatment of Recurrent Vulvovaginal Candidiasis (RVVC), a debilitating, chronic infectious condition that affects nearly 138 million women worldwi...
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