As the US con­tin­ues to mon­i­tor the im­pact of vari­ants on au­tho­rized mon­o­clon­al an­ti­bod­ies (mAbs) and shake up which mAbs are dis­trib­uted where, Glax­o­SmithK­line and Vir Biotech­nol­o­gy said Fri­day that they’re seek­ing an emer­gency use au­tho­riza­tion for their own mAb.

The com­pa­nies are sub­mit­ting an ap­pli­ca­tion for their mAb, known as VIR-7831, as a treat­ment for adults and ado­les­cents (12 years and old­er) with mild-to-mod­er­ate Covid-19 who are at risk for pro­gres­sion to hos­pi­tal­iza­tion or death.

The sub­mis­sion is based on an in­ter­im analy­sis of ef­fi­ca­cy and safe­ty da­ta from a Phase III tri­al of 583 pa­tients, which demon­strat­ed an 85% (p=0.002) re­duc­tion in hos­pi­tal­iza­tion or death in those re­ceiv­ing VIR-7831 com­pared to place­bo. The tri­al’s In­de­pen­dent Da­ta Mon­i­tor­ing Com­mit­tee rec­om­mend­ed that the tri­al stop en­roll­ment be­cause of the ear­ly sign of ef­fi­ca­cy.

The com­pa­ny al­so said the mAb may be pro­tec­tive against some of the cir­cu­lat­ing vari­ants. New in vit­ro da­ta pub­lished as a pre-print ear­li­er this month showed the mAb main­tains ac­tiv­i­ty against cur­rent vari­ants of con­cern orig­i­nat­ing in the UK, South Africa and Brazil. Ad­di­tion­al pre­clin­i­cal da­ta showed the mAb al­so ap­pears to main­tain ac­tiv­i­ty against the Cal­i­for­nia vari­ant, the com­pa­ny said.

The news of the sub­mis­sion comes as the US gov­ern­ment and Eli Lil­ly agreed to halt all dis­tri­b­u­tion of the com­pa­ny’s Covid-19 mon­o­clon­al an­ti­body bam­lanivimab as of Wednes­day due to the “sus­tained in­crease” of vari­ants in the US.

“We rec­og­nize the U.S. gov­ern­ment has made the de­ci­sion to no longer al­low di­rect or­der­ing of bam­lanivimab alone due to con­cerns about the preva­lence of the Cal­i­for­nia (B.1.427/B.1.429) and New York (B.1.526) vari­ants of SARS-CoV-2. The U.S. gov­ern­ment has en­abled di­rect or­der­ing of bam­lanivimab and ete­se­vimab to­geth­er as well as ete­se­vimab alone, to pair with bam­lanivimab that sites of care have on hand,” Lil­ly said.

Lil­ly is al­so spon­sor­ing an on­go­ing Phase 2 tri­al eval­u­at­ing VIR-7831 in the out­pa­tient set­ting in com­bi­na­tion with bam­lanivimab in low-risk adults with mild to mod­er­ate Covid-19.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.