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Lexaria Gets FDA’s Positive Feedback On Pre-Clinical Trial Of Hypertension Candidate

By Ragothaman Srinivasan
August 10, 11:36 AM
Lexaria Bioscience Corp. (NASDAQ: LEXX) announced that it has received a positive full written response from the Food and Drug Administration (FDA) from its pre-Investigational New Drug meeting regarding DehydraTECH-CBD for the treatment of hypertension.

LEXX

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Biotech Daily: Cancer Causing Impurities In Merck’s Diabetic Drug, Vir Bio-GSK Shun FDA Submission Plans For COVID-19 Treatment, Aethlon’s Monkeypox Trial

By Vandana Singh
August 10, 11:33 AM
Here's a roundup of top developments in the biotech space over the last 24 hours:

ADMP

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GSK Confirms Rotavirus Vaccine Shortage, Hits Four African Countries: Report

By Vandana Singh
August 10, 11:18 AM
After disruptions at GSK plc (NYSE:GSK), supplies of rotavirus infection vaccine in children have either run out in Kenya, Tanzania,…

GSK

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Organogenesis’ Q2 Operating Income Fell 50%, Lowers Annual Guidance

By Vandana Singh
August 10, 11:10 AM
Organogenesis Holdings Inc’s (NASDAQ:ORGO) Q2 FY22 sales reached $121.4 million, down 1% Y/Y, slightly ahead of the consensus of $120.90…

ORGO

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Aridis’ Inhaled Pan-Coronavirus Antibody Cocktail Shows Encouraging Preclinical Action

By Vandana Singh
August 10, 10:40 AM
Aridis Pharmaceuticals Inc’s (NASDAQ:ARDS) inhaled treatment of its fully human monoclonal antibody cocktail AR-701 resulted in no detectable SARS-CoV-2 virus in…

ARDS

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VYNE Therapeutics Shares Disappointing Data From Atopic Dermatitis Trial

By Vandana Singh
August 10, 10:34 AM
VYNE Therapeutics Inc (NASDAQ: VYNE) has announced results from the Phase 2a segment of Phase 1b/2a trial evaluating FMX114 for mild-to-moderate atopic dermatitis.

VYNE

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To Avoid Supply Crunch, FDA Temporarily Allows Higher Impurity Levels In Merck’s Diabetes Drug: Report

By Vandana Singh
August 10, 7:43 AM
The FDA recently became aware of a nitrosamine impurity, Nitroso-STG-19 or NTTP, in certain samples of Merck & Co Inc's (NYSE: MRK) type 2 diabetes drug Januvia/Janumet (sitagliptin).

MRK

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Recap of Tuesday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan
August 9, 6:29 PM
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Relmada Therapeutics’ (NASDAQ:RLMD) lead asset…

BGNE

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Analysts See Softened Timelines For CRISPR Therapeutics’ Sickle Cell Candidate In US

By Vandana Singh
August 9, 3:26 PM
Barclays says that CRISPR Therapeutics AG’s (NASDAQ: CRSP) Q2 FY22 earnings release was largely incremental, highlighting the progress of multiple clinical programs, including the…

BLUE

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Smiths Acquisition Weighs On ICU Medical’s Profitability, Shares Fall

By Vandana Singh
August 9, 3:15 PM
ICU Medical Inc (NASDAQ:ICUI) reported Q2 sales of $561 million, up 75% Y/Y, due to Smiths Medical’s acquisition, and missing…

ICUI

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