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

Here's a roundup of top developments in the biotech space over the last 24 hours:

Stocks In Focus

Vir Biotech Shuns FDA Submission Plans For GSK-Partnered COVID-19 Treatment

The company also said it does not intend to pursue the U.S.-based Phase 3 COMET-STAR prophylaxis trial, citing evolving COVID-19 landscape and FDA discussions.

Discussions with the FDA remain ongoing regarding the appropriate path forward for sotrovimab in the U.S.

Aethlon Medical To Start Lab Studies For Hemopurifier For Monkeypox

In 2008, the company conducted an in vitro study demonstrating that the Hemopurifier effectively bound and removed the monkeypox virus.

The study indicated that the Hemopurifier removed 44% of the monkeypox virus in the first hour of testing, 82% after six hours, and 98% after 20 hours.

SAB Biotherapeutics Shifts Focus On Infection Candidate As DoD Contract Closes

The conclusion will allow the company to focus on its core priorities and expand its current pipeline.

FDA Temporarily Allows Higher Impurity Levels In Merck's Diabetes Drug

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).

Evotec, Alpine Expand Pact For Commercial Process Development Of Autoimmune Disease Candidate

Just - Evotec Biologics will leverage its data-driven technology platform to develop a commercial manufacturing process for ALPN-303. 

2seventy bio Shares Jump On Positive Data From Bristol Myers-Partnered Cancer Immunotherapy

The interim analysis demonstrated a statistically significant improvement in progression-free survival. 

Treatment with Abecma also showed an improvement in the key secondary endpoint of overall response rate compared to standard regimens. 

Centessa Culls Early-Stage Asset For Inherited Disorder

Based on the results observed, the company concluded that ZF874 was unlikely to achieve the desired target product profile.

Gemini Therapeutics Announces Reverse Merger Pact With Hematology-Focused Company

The combined company will focus on advancing Disc's pipeline of hematology programs, including multiple patient studies for its clinical-stage programs bitopertin and DISC-0974. 

The combined company will operate under the Disc Medicine moniker, trade on the Nasdaq Global Market under the 'IRON' ticker, and be led by Disc Medicine's CEO, John Quisel.

Caladrius's Merger Partner Inks Trial Pact With Roche

Under the terms of the agreement, Roche will be responsible for the operational management of the trial, while Cend and Roche share equally in the costs of the CEND-1 treatment arms in the study.

VYNE Therapeutics Shares Disappointing Data From Atopic Dermatitis Trial

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.

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

The candidate also protected their lungs from disease. 

AR-701 was effective in non-human primates as a prophylactic or therapeutic treatment regimen.

Offering

On The Radar

Earnings

Adamis Pharmaceuticals Corp (NASDAQ:ADMP): After market close.

Ascendis Pharma A/S (NASDAQ:ASND): After market close.

Eyenovia Inc (NASDAQ:EYEN): After market close.

DiaMedica Therapeutics Inc (NASDAQ:DMAC): After market close.

TRACON Pharmaceuticals Inc (NASDAQ:TCON): After market close.

BioCardia Inc (NASDAQ:BCDA): After market close.

Cyclacel Pharmaceuticals Inc (NASDAQ:CYCC): After market close.

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