The hold­ing com­pa­ny of a South Ko­re­an vac­cine mak­er is in the fi­nal talks to make an in­vest­ment in­to a US gene ther­a­py firm.

SK Bio­sciences is in the process of sign­ing a deal with the Cen­ter for Break­through Med­i­cines (CBM), a Philadel­phia-based CD­MO. If fi­nal­ized, the deal will come eight months af­ter SK’s takeover of the French gene and cell ther­a­py com­pa­ny Yposke­si.

With this move, SK takes it­self a step clos­er to es­tab­lish­ing a val­ue chain of syn­thet­ic and bio phar­ma­ceu­ti­cals in the US, Eu­rope and Asia by 2025, the com­pa­ny’s head of the in­vest­ment cen­ter Lee Dong-hoon said in a pre­sen­ta­tion. The CBM is known for its pro­duc­tion of plas­mid DNA. With SK’s in­vest­ment, it will ex­pand man­u­fac­tur­ing fa­cil­i­ty in the Cel­li­con Val­ley cell and gene ther­a­py clus­ter by 699,654 square feet.

That project will be com­plet­ed by 2025, The Ko­rea Her­ald says.

CBM was es­tab­lished in 2019 and of­fers ful­ly-in­te­grat­ed pre-clin­i­cal through com­mer­cial man­u­fac­tur­ing ca­pa­bil­i­ties that in­clude process de­vel­op­ment, plas­mid DNA, and vi­ral vec­tor man­u­fac­tur­ing, cell bank­ing, cell pro­cess­ing, and a full suite of test­ing and an­a­lyt­ic ca­pa­bil­i­ties. The fi­nanc­ing is set to close in De­cem­ber.

“We are thrilled by the op­por­tu­ni­ty to join forces with SK Inc., the per­fect strate­gic part­ner to en­able CBM’s core mis­sion of ex­pe­dit­ing the path to ap­proval for cell and gene ther­a­pies for pa­tients in need,” said co-founder of CBM Au­drey Green­berg in a press re­lease. “SK’s mis­sion of de­liv­er­ing val­ue and hap­pi­ness for all, cul­ture of safe­ty and qual­i­ty, em­pha­sis on ESG val­ues, and glob­al reach cre­ates an ide­al match for CBM. SK has a strong bio­phar­ma port­fo­lio, in­clud­ing con­sid­er­able in­vest­ments in cell & gene ther­a­py com­pa­nies cre­at­ing enor­mous strate­gic val­ue for CBM.  The SK CBM part­ner­ship will bring ca­pac­i­ty to a starved CGT mar­ket­place and ex­pe­dite the de­liv­ery of new ther­a­pies to pa­tients who need them now.”

SK ex­pand­ed its vac­cine pro­duc­tion in a big way over the sum­mer, af­ter it an­nounced it would in­vest $132 mil­lion in pro­duc­tion ca­pac­i­ty in mR­NA and vi­ral vec­tor op­er­a­tions in a project set to be op­er­a­tional by 2024. That ex­pan­sion will add more than 1 mil­lion square feet of pro­duc­tion space in An­dong, and was the first site in the coun­try to get the OK for Covid-19 vac­cine man­u­fac­tur­ing on the con­ti­nent.

It al­so re­ceived back­ing from CEPI, a coali­tion that backed both Mod­er­na and Ox­ford, and with it, $173.4 mil­lion to fin­ish its clin­i­cal tri­als and scale up man­u­fac­tur­ing to work on a vac­cine that de­liv­ers at low dos­es.

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.