Two heavy­weight phar­ma play­ers to­day said they’ve been forced to stop re­cruit­ing pa­tients for all on­go­ing stud­ies in­volv­ing Ven­clex­ta (vene­to­clax) for mul­ti­ple myelo­ma. Roche and Ab­b­Vie say the drug arm has been linked to a high­er rate of death than the con­trol group, prompt­ing the FDA to is­sue a par­tial hold or­der­ing them to sus­pend any new pa­tient re­cruit­ment for the blood can­cer tri­als un­til they can sort out what is hap­pen­ing.

In the study, 21.1% — 41 of 194 pa­tients — in the vene­to­clax arm com­pared with 11.3% — 11 of 97 pa­tients — in the place­bo arm died, cre­at­ing a haz­ard ra­tio of 2.03.

Michael Sev­eri­no

Ini­tial­ly stamped with an ac­cel­er­at­ed ap­proval for CLL back in 2016, this drug has been hur­ried along by the FDA with a to­tal of 5 break­through drug des­ig­na­tions. Both com­pa­nies are cred­it­ed with top in­ves­tiga­tive teams and a keen in­ter­est in the on­col­o­gy mar­ket.

The sud­den halt on re­cruit­ment will like­ly put a crimp in their plans to hit $3 bil­lion in peak sales for the drug, which was ini­tial­ly lim­it­ed to pa­tients with a 17p dele­tion, ac­count­ing for about 10% of all cas­es. Last sum­mer they got an ap­proval to use the drug with Rit­ux­an for re­lapsed CLL, an add-on that Leerink’s Ge­of­frey Porges es­ti­mat­ed could be worth $690 mil­lion this year alone.

This was the Phase III BELLI­NI tri­al (M14-031), one of dozens of on­go­ing clin­i­cal tri­als that the phar­ma gi­ants are pur­su­ing for this ther­a­py, ac­cord­ing to a quick check of clin­i­cal­tri­als.gov.

“We will con­tin­ue work­ing with the FDA and world­wide reg­u­la­to­ry agen­cies to de­ter­mine ap­pro­pri­ate next steps for the mul­ti­ple myelo­ma pro­gram,” said Ab­b­Vie re­search chief Michael Sev­eri­no in a pre­pared state­ment.

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.

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.

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.