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Tech con­glom­er­ate buys Me­di­da­ta for $5.7B; Alexan­dria teams up with Co­lum­bia for sec­ond Launch­Labs; So­bi all in on ema­palum­ab

→ Clin­i­cal tri­al soft­ware provider Me­di­da­ta is get­ting ac­quired in a $5.8 bil­lion deal. The all-cash buy­er, Das­sault Sys­temes, is a French tech­nol­o­gy com­pa­ny that’s his­tor­i­cal­ly fo­cused on 3D de­sign and en­gi­neer­ing. “Life sci­ence is go­ing to go through an ac­cel­er­at­ed dig­i­ti­za­tion of its own process­es, ba­si­cal­ly,” Das­sault CEO Bernard Charles told CN­BC. Hav­ing pow­ered op­er­a­tions and da­ta analy­sis for hun­dreds of bio­phar­ma com­pa­nies, CROs and re­searcher cen­ters, Me­di­da­ta’s plat­form is poised to lead the vir­tu­al trans­for­ma­tion in the in­dus­try, he added.

Nas­daq delists In­sys af­ter bank­rupt­cy fil­ing; Chi­na's Zai Lab li­cens­es sol­id tu­mor drug from De­ci­phera

→ On the heels of a bank­rupt­cy fil­ing, In­sys an­nounced that it’s get­ting delist­ed from the Nas­daq. Trad­ing of the stock $IN­SY — rel­e­gat­ed to the over-the-mar­ket these days — will come to a halt on June 19, 2019. The opi­oid mak­er, which agreed to pay $225 mil­lion to set­tle the US gov­ern­ment’s in­ves­ti­ga­tions in­to the mar­ket­ing prac­tices around its fen­tanyl spray Sub­sys, does not plan on ap­peal­ing the de­ter­mi­na­tion.

FDA sends No­vaVax back to the clin­ic; Stoke Ther­a­peu­tics sets terms for up­sized $101M IPO

→ A be­lea­guered No­vaVax has run in­to a ma­jor hur­dle on its RSV vac­cine’s quest to mar­ket. The FDA is ask­ing the com­pa­ny to con­duct a whole new Phase III tri­al to con­firm that ResVax can pro­tect in­fants from “med­ical­ly sig­nif­i­cant RSV dis­ease” if their moth­ers were vac­ci­nat­ed. While it’s sort­ing out the sit­u­a­tion in the US and Eu­rope, No­vaVax said it will con­tin­ue work­ing with its back­ers at the Bill & Melin­da Gates Foun­da­tion to in­tro­duce the vac­cine in low to mid­dle in­come coun­tries.

Ot­su­ka scores PhI­II win for an­oth­er As­tex drug; GSK ex­pands Nu­cala use in asth­ma

→ Ot­su­ka has some good news to re­port on the oth­er drug that it ob­tained in the $886 mil­lion ac­qui­si­tion of As­tex Phar­ma­ceu­ti­cals. ASTX727 com­bines the chemother­a­py decitabine with cedazuri­dine, an oral in­hibitor of cy­ti­dine deam­i­nase. A Phase III study eval­u­at­ing the com­bo and in­ter­me­di­ate to high-risk myelodys­plas­tic syn­drome and chron­ic myelomono­cyt­ic leukemia met its pri­ma­ry end­point, the com­pa­ny said.

Vivek Ra­maswamy re­cruits Eli Lil­ly R&D vet Salz­mann as new CEO; Ax­o­vant drops col­lab­o­ra­tion

→ Vivek Ra­maswamy has re­cruit­ed Eli Lil­ly R&D vet Pe­te Salz­mann to take the helm at one of his new vants. Salz­mann is the new CEO at Im­muno­vant, which is work­ing on IMVT-1401, a mon­o­clon­al an­ti­body in de­vel­op­ment for the treat­ment of au­toim­mune dis­eases me­di­at­ed by path­o­gen­ic IgG an­ti­bod­ies. Salz­mann had been in charge of the de­vel­op­ment pro­gram for Olu­mi­ant (baric­i­tinib), which proved trou­ble­some for Eli Lil­ly as reg­u­la­tors raised se­ri­ous con­cerns about safe­ty.

Deer­field strikes up new deal with Co­lum­bia Uni­ver­si­ty; Ovid CEO Je­re­my Levin joins BIO as new board chair

→ In its lat­est deal, health­care in­vest­ment firm Deer­field Man­age­ment and Co­lum­bia Uni­ver­si­ty have col­lab­o­rat­ed to launch Hud­son Heights In­no­va­tions “to cat­alyze the de­vel­op­ment of nov­el ther­a­peu­tics out of the re­search labs of Co­lum­bia Uni­ver­si­ty”. Deer­field and its part­ners will pro­vide up to $130 mil­lion in ini­tial fund­ing to back the ini­tia­tive for over 10 years. 

“Much of our re­search is aimed at un­der­stand­ing at the mol­e­c­u­lar lev­el how dis­eases de­vel­op and how we can in­ter­vene with drugs or oth­er ther­a­peu­tics,” said Lee Gold­man, dean of the fac­ul­ties of health sci­ences and med­i­cine and chief ex­ec­u­tive of Co­lum­bia Uni­ver­si­ty Irv­ing Med­ical Cen­ter.

Cel­gene/Ac­celeron win speedy FDA re­view for lus­pa­ter­cept in be­ta tha­lassemia; Ko­re­an in­vestor out to shake up Au­rini­a's board

→ As hoped, Cel­gene $CELG and its part­ners at Ac­celeron $XL­RN have se­cured pri­or­i­ty re­view for their red blood cell boost­ing drug, lus­pa­ter­cept, which has been pegged to even­tu­al­ly gen­er­ate peak sales of $2 bil­lion. The bi­o­log­ic has been de­vel­oped to man­age ane­mia re­sult­ing from myelodys­plas­tic syn­drome (MDS) as well as be­ta tha­lassemia. The FDA ex­pects to make its de­ci­sion on the be­ta-tha­lassemia in­di­ca­tion by De­cem­ber 4, while the MDS in­di­ca­tion will be dealt with by April 4, 2020. The Eu­ro­pean re­view of the drug is al­so un­der­way, the com­pa­nies said on Tues­day.

Eye­Gate surges on FDA nod to start piv­otal study; Alde­vron to build gene ther­a­py man­u­fac­tur­ing cam­pus in Far­go, N.D.

→ Eye­Gate — a phar­ma­ceu­ti­cal com­pa­ny spe­cial­iz­ing in de­vel­op­ing treat­ments for dis­eases and dis­or­ders of the eye — an­nounced the FDA’s ap­proval to ini­ti­ate its pho­tore­frac­tive ker­a­te­c­to­my (PRK) piv­otal study. The FDA has asked for mod­i­fi­ca­tions to be made to the pa­tient in­formed con­sent doc­u­ment pri­or to pa­tient en­roll­ment in the study and the com­pa­ny says that it will ad­dress these mod­i­fi­ca­tions im­me­di­ate­ly and ex­pects en­roll­ment to be­gin next month.

Novo's in­vest­ment arm in­jects $67.5M in Ox­ford Bio­med­ica; Aba­cus Med­i­cine de­lays IPO plans

→ The in­vest­ment arm of Dan­ish drug­mak­er No­vo Nordisk $NVO is in­vest­ing £53.5 mil­lion (about $67.5 mil­lion) in UK-based gene and cell ther­a­py group Ox­ford Bio­med­ica (LSE:OXB), in ex­change for 10.1% of the com­pa­ny’s out­stand­ing shares. Ox­ford, which has part­nered with No­var­tis $NVS and Sanofi $SNY, as well as out-li­cens­ing of an as­set to Ax­o­vant $AXGT, will use the pro­ceeds to re­pay its debt and fund the de­vel­op­ment of its LentiVec­tor plat­form, the com­pa­ny said on Wednes­day.

No­var­tis backs $30M round for can­cer biotech; Bay­er drug makes a ‘break­through’ at FDA

→ Ay­ala Ther­a­peu­tics — which fo­cus­es on rare can­cers that oc­cur due to dys­reg­u­la­tion of the Notch-ac­ti­vat­ing path­way — has raised $30 mil­lion in a round of fi­nanc­ing led by part­ner No­var­tis.

The funds, which al­so came from in­vestors in­clud­ing SBI JI In­no­va­tion Fund, Is­rael Biotech Fund, aMoon and Harel In­sur­ance & Fi­nance Group, will be used to fu­el the de­vel­op­ment of its lead drug, AL101. The pan-Notch in­hibitor is cur­rent­ly be­ing eval­u­at­ed for ade­noid cys­tic car­ci­no­ma (ACC) in a Phase II tri­al, and the com­pa­ny is al­so plan­ning to in­ves­ti­gate its use in a mid-stage study in triple neg­a­tive breast can­cer.