GlaxoSmithKline-Vir COVID-19 Antibody Drug Granted EUA In U.S.
LONDON (dpa-AFX) - The U.S. Food and Drug Administration has granted an emergency use authorization for a COVID-19 antibody drug made by GlaxoSmithKline (GSK, GSK.L) and Vir Biotechnology.
Sotrovimab, an investigational monoclonal antibody therapy, has been authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients aged 12 years and older who are at high risk for progressing to severe COVID-19, including hospitalization or death, the FDA said in a statement on Wednesday.
The emergency use authorization allows for sotrovimab to be distributed and administered as a 500 milligram single dose intravenously by health care providers.
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Initiates Multi-Center, Multi-Arm Trial Using Active Dose Identified in the Dose Escalation Phase of the Trial
SEATTLE, WA / ACCESSWIRE / May 27, 2021 / Aptevo Therapeutics Inc. ( Aptevo ) (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR
TM and ADAPTIR-FLEX
TM platform technologies today announced that the company has initiated the expansion phase of lead anti-leukemia drug candidate, APVO436, in adult patients with acute myeloid leukemia (AML) with a multi-center, multi-arm trial using the active recommended dose identified in the dose escalation phase (Part 1) of the study. During Part 1, APVO436 exhibited a manageable side effect profile, encouraging single agent activity and a promising benefit to risk profile in relapsed AML patients. The Company has plans to submit data from the dose escalation phase for publication later this year.
(0) Trial evaluates opportunity to improve outcomes based on emerging data that immunomodulation may offer clinical benefit
Horizon Therapeutics plc (Nasdaq: HZNP) today announced the first patient has enrolled in the ADVANCE trial evaluating the concomitant use of KRYSTEXXA (pegloticase injection) with methotrexate for people with uncontrolled gout who were not able to achieve a complete response when previously treated with KRYSTEXXA monotherapy.
For people with chronic gout refractory to conventional therapies (uncontrolled gout), KRYSTEXXA offers a unique mechanism of action that converts urate into allantoin which can more easily and efficiently be excreted by the kidneys.
1 Similar to other biologic medicines, patients on KRYSTEXXA monotherapy can develop anti-drug antibodies that prevent them from completing a full course of therapy. Increasingly, immunomodulating therapies, such as methotrexate, have been employed to help reduce the development of anti-drug antibodie
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Fayette County fourth and fifth graders learn how to kayak at the lake at Fayette County Park during the first Project: Adventure in 2019. The 2021 event, now dubbed Adventure: Fayette County, has expanded from a 2-day event at the park to activities scheduled for nearly two months at four locations in the county. Because of the growth of the program, additional volunteers are needed this summer. For information, or to volunteer, call 304-860-5106 or email adventurefayette@gmail.com.
File photo
By Cheryl Keenan
The Fayette Tribune May 27, 2021
4 hrs ago
Fayette County fourth and fifth graders learn how to kayak at the lake at Fayette County Park during the first Project: Adventure in 2019. The 2021 event, now dubbed Adventure: Fayette County, has expanded from a 2-day event at the park to activities scheduled for nearly two months at four locations in the county. Because of the growth of the program, additional volunteers are needed this summ
WASHINGTON (dpa-AFX) - Biopharmaceutical company Seelos Therapeutics Inc. (SEEL) announced Thursday that it has received a positive opinion on European Orphan Drug Designation for SLS-005 in Amyotrophic