Six months af­ter first boast­ing about Phase III da­ta, As­traZeneca has earned ex­pand­ed FDA ap­proval for its BTK in­hibitor Calquence. The drug will now be used to treat one of the most com­mon adult blood can­cers, chron­ic lym­pho­cyt­ic leukemia (CLL).

In the spring, the Eu­ro­pean gi­ant called its shot ear­ly, point­ing to­ward reg­u­la­to­ry sub­mis­sions as in­ter­im tri­al da­ta came out. They said in May the drug had aced a Phase III tri­al as a sec­ond-line CLL treat­ment. Then in June, they an­nounced high pro­gres­sion-free sur­vival from pa­tients in a tri­al of pa­tients who re­ceived Calquence as a front­line ther­a­py.

The drug is now ap­proved as a sin­gle agent and as a com­bi­na­tion ther­a­py for front­line and sec­ond-line treat­ment. The drug is al­so ap­proved to treat SLL or small lym­pho­cyt­ic leukemia, which is the same dis­ease as CLL but ap­pears in the lymph nodes as op­posed to blood or bone mar­row. Pre­vi­ous­ly, it was on­ly ap­proved for man­tle cell lym­phoma.

The EL­E­VATE-TN study on Calquence as a front­line treat­ment showed the drug low­ered the risk of dis­ease pro­gres­sion or death by 90% in com­bi­na­tion with an­oth­er ther­a­py and by 80% as a monother­a­py.

José Basel­ga As­traZeneca

De­spite Imfinzi’s con­tin­ued stum­bles, As­traZeneca’s on­col­o­gy group has large­ly thrived un­der new chief José Basel­ga, who ar­rived at the phar­ma gi­ant af­ter a con­tro­ver­sial ex­it at Memo­r­i­al Sloan Ket­ter­ing. In Au­gust, the com­pa­ny an­nounced two more rounds of strong Phase III da­ta from their PARP in­hibitor Lyn­parza, first in prostate can­cer and then in ovar­i­an can­cer.

Calquence is part of the next gen­er­a­tion of BTK in­hibitors that have promised to be safer and more tol­er­a­ble to pa­tients. These in­hibitors block Bru­ton’s ty­ro­sine ki­nase, an en­zyme that plays a role in onco­genic sig­nal­ing and the rise of some leukemic cells. J&J and Ab­b­Vie un­veiled the first such drug, Im­bru­vi­ca, in 2013, but de­spite bil­lions in rev­enue, the drug can have steep side ef­fects.

Ear­li­er this month, the FDA ap­proved BeiGene’s sec­ond-gen­er­a­tion BTK in­hibitor, Brukin­sa, for man­tle cell lym­phoma. It was the first-ever Chi­nese can­cer drug ap­proved in the US.

The US House of Representatives is taking a further interest in domestic pharma manufacturing by creating the Domestic Pharmaceutical Manufacturing Caucus, led by Reps. Buddy Carter (R-GA), Elissa Slotkin (D-MI), Gus Bilirakis (R-FL) and Chrissy Houlahan (D-PA).

As the supply chain increasingly is outsourced to China and India, particularly on the active pharmaceutical ingredient side, the caucus will aim to focus on moving forward legislation that incentivizes greater domestic manufacturing of medicines. Carter said the caucus will try to reduce US reliance on “foreign adversaries,” try to ensure an adeqate supply of pharmaceuticals and try to halt supply chain disruptions.

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.