New York-based re­al world ev­i­dence, or RWE, firm Ae­tion is team­ing up with the Na­tion­al In­sti­tute for Health and Care Ex­cel­lence in the Unit­ed King­dom to an­a­lyze da­ta such as hos­pi­tal records, pre­scrip­tion records and more to study clin­i­cal ef­fec­tive­ness and fill gaps in ev­i­dence.

Car­olyn Mag­ill

As Ae­tion CEO Car­olyn Mag­ill told End­points News, the com­pa­ny’s goal is to col­lect ev­i­dence that would be hard­er to get out­side of a con­trolled set­ting, such as a clin­i­cal tri­al.

“So [in a clin­i­cal tri­al] you have a nurse tap­ping you on the shoul­der say­ing, ‘Did you take your med­ica­tion to­day? Did you al­ways take it at the same point in time?’ Where­as once the drug is on the mar­ket, our reg­u­lar lives get in the way,” Mag­ill said.

Mag­ill said that RWE helps cap­ture what hap­pens to pop­u­la­tions who may be un­der­rep­re­sent­ed in clin­i­cal tri­als — such as women of child­bear­ing age, chil­dren, and those who have dif­fer­ent com­bi­na­tions of chron­ic ill­ness­es.

In April, af­ter talk­ing for sev­er­al years, rep­re­sen­ta­tives from NICE and Ae­tion worked along­side rep­re­sen­ta­tives from the EMA and co-pub­lished a pa­per on a pos­si­ble struc­ture for or­ga­niz­ing frag­ment­ed RWE rec­om­men­da­tions world­wide to achieve com­pre­hen­sive guid­ance. That col­lab­o­ra­tion marked Ae­tion’s first part­ner­ship with an in­ter­na­tion­al HTA body, ac­cord­ing to a com­pa­ny state­ment an­nounc­ing the col­lab­o­ra­tion.

“As NICE con­tin­ues to de­liv­er on our five-year strate­gic vi­sion, in­clud­ing rapid, ro­bust, and re­spon­sive tech­nol­o­gy eval­u­a­tion, un­der­stand­ing how to make the best use of RWE is vi­tal in help­ing us re­solve gaps in knowl­edge and dri­ving for­ward ac­cess to in­no­va­tions for pa­tients,” Páll Jóns­son, NICE’s pro­gramme di­rec­tor for da­ta, said in a state­ment.

4D’s aerosolized cys­tic fi­bro­sis gene ther­a­py cleared for hu­man tri­als

Biotech 4D Mol­e­c­u­lar Ther­a­peu­tics said to­day that their in­ves­ti­ga­tion­al, cys­tic fi­bro­sis gene ther­a­py 4D-710 has been cleared by the FDA for clin­i­cal tri­als with an ap­proved IND.

4D ex­pects to be able to start a Phase I/II clin­i­cal tri­al with ap­prox­i­mate­ly 18 pa­tients be­fore the end of the year.

David Kirn

“Ul­ti­mate­ly, we be­lieve 4D-710 has the po­ten­tial to treat a broad cys­tic fi­bro­sis pa­tient pop­u­la­tion, in­clud­ing those pa­tients treat­ed with cur­rent CFTR mod­u­la­tors, all of which re­quire dai­ly dos­ing over the pa­tient’s life­time and gen­er­al­ly re­sult in on­ly par­tial cor­rec­tion of lung func­tion,” said 4DMT CEO and co-founder David Kirn in a state­ment.

This an­nounce­ment comes just a few months af­ter Roche sev­ered their part­ner­ship with 4D, re­sult­ing in shares of $FDMT tank­ing 10%.

The non-prof­it Cys­tic Fi­bro­sis Foun­da­tion will pur­chase 125,715 shares of 4D’s com­mon stock for fur­ther de­vel­op­ment of the drug for ap­prox­i­mate­ly $4 mil­lion, ac­cord­ing to a com­pa­ny state­ment.

CRO In­o­tiv buys out Pla­to Bio­Phar­ma in $15 mil­lion deal

In­di­ana-based CRO In­o­tiv is ac­quir­ing in vi­vo re­search firm Pla­to Bio­phar­ma as part of an in vi­vo phar­ma­col­o­gy ex­pan­sion, ac­cord­ing to a com­pa­ny an­nounce­ment to­day.

In a $15 mil­lion deal with $10 mil­lion in cash, along with com­mon shares and promis­so­ry notes mak­ing up the oth­er $5 mil­lion, In­o­tiv ex­pects to re­tain all 34 of Pla­to’s em­ploy­ees af­ter the trans­ac­tion is com­plete.

“The ac­qui­si­tion of PBI marks an­oth­er mile­stone for In­o­tiv as we con­tin­ue to ex­e­cute on our strat­e­gy to build a com­plete range of con­tract re­search ser­vices,” said In­o­tiv chief strat­e­gy of­fi­cer John Sagartz. “This ad­di­tion al­lows us to sup­port and ac­cel­er­ate PBI’s growth plans, while fur­ther ex­pand­ing in­to more phys­i­o­log­ic and phar­ma­co­log­ic of­fer­ings.”

“We look for­ward to join­ing the team and broad­en­ing In­o­tiv’s ser­vice of­fer­ing,” Pla­to founder and CEO Craig Pla­to said in a state­ment. “Our core val­ues and col­lab­o­ra­tive ap­proach align well, and our fo­cus on rig­or­ous sci­en­tif­ic ex­e­cu­tion and ded­i­ca­tion to de­liv­er­ing ex­cep­tion­al client ex­pe­ri­ence will con­tin­ue to be para­mount.”

Xi Jin­ping calls for im­proved and in­creased biose­cu­ri­ty mea­sures against zoonot­ic dis­ease trans­mis­sion

Chi­nese Pres­i­dent Xi Jin­ping called for “ac­tive de­fens­es” last week to pre­vent an­i­mal-to-hu­man trans­mis­sion of dis­eases dur­ing his ad­dress to the Po­lit­i­cal Bu­reau of the CPC Cen­tral Com­mit­tee.

In a group ses­sion on biose­cu­ri­ty, Xi, who is al­so the gen­er­al sec­re­tary of the Com­mu­nist Par­ty of Chi­na (CPC) Cen­tral Com­mit­tee, called for a man­age­ment net­work to re­spond to any po­ten­tial dis­eases that might arise in the fu­ture.

He al­so stressed more su­per­vi­sion over the safe­ty of bi­o­log­i­cal re­sources. Specif­i­cal­ly, Xi point­ed out a need to strength­en ex­am­i­na­tion of im­port­ed goods, and urged pun­ish­ment for all il­le­gal acts.

Call­ing the buildup of biose­cu­ri­ty “a long-term and ar­du­ous task,” Xi urged con­tin­u­al ef­forts and promised to take part in world biose­cu­ri­ty gov­er­nance.

EQRx to col­lab­o­rate with new­ly-pub­lic Ab­sci on pro­tein-based ther­a­peu­tics

EQRx an­nounced a dis­cov­ery col­lab­o­ra­tion with Ab­sci to­day to ad­vance pro­tein-based ther­a­peu­tics.

Ab­sci went pub­lic just a few months ago in Ju­ly, where it raised $200 mil­lion at $16 a share.

The two com­pa­nies will col­lab­o­rate to joint­ly en­gi­neer and de­vel­op sev­er­al clin­i­cal can­di­dates across mul­ti­ple ther­a­peu­tic ar­eas, in­clud­ing on­col­o­gy and im­munol­o­gy. Ab­sci has the op­tion to make ad­di­tion­al in­vest­ments at dif­fer­ent stages of de­vel­op­ment in ex­change for an in­creased share of prod­uct sales.

“We are ex­cit­ed to work with Ab­sci to­wards our goal of pro­vid­ing in­no­v­a­tive, cost-ef­fec­tive treat­ment op­tions for pa­tients,” said EQRx chief of Rx cre­ation Car­los Gar­cia-Echev­er­ria in a state­ment.


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