R&D channel feed

FDA lifts clin­i­cal hold on Mer­sana’s STING ag­o­nist, PhI start­ing dose low­ered af­ter pa­tient death

Last year

As Sarep­ta ex­ecs talk up Duchenne con­fir­ma­to­ry tri­al re­sults, in­vestors and an­a­lysts re­main di­vid­ed on how flex­i­ble FDA will be

Last year
FDA+

GSK steps in for J&J’s li­cense of Ar­row­head’s he­pati­tis B drug, plans com­bo study with its own can­di­date

Last year
Deals
Pharma

En­gine Bio­sciences bags $27M Se­ries A ex­ten­sion to ad­vance pre­ci­sion med­i­cine plat­form in on­col­o­gy

Last year
Financing

Sarep­ta's con­fir­ma­to­ry Duchenne tri­al fails to meet end­point, com­pli­cat­ing fu­ture for con­tro­ver­sial drug

Last year
Cell/Gene Tx

De­ci­phera says its drug for rare joint tu­mor suc­ceed­ed in a PhI­II study, will sub­mit to FDA

Last year

Post-pan­dem­ic and flush with cash, Vir eyes new fron­tiers in on­col­o­gy and neu­rol­o­gy

Last year

Mer­ck KGaA pays $169M up­front in deal for Hen­grui’s PARP1 in­hibitor and ADC

Last year
Deals

No­var­tis plans for po­ten­tial ac­cel­er­at­ed ap­proval for kid­ney dis­ease drug af­ter PhI­II in­ter­im analy­sis re­sult

Last year

GSK's Jem­per­li meets over­all sur­vival pri­ma­ry end­point in PhI­II study

Last year

Re­gen­eron gives first glimpse at hear­ing loss gene ther­a­py

Last year
Cell/Gene Tx

PTC finds it­self in quag­mire of reg­u­la­to­ry set­backs, push­es back time­line on PKU treat­ment

Last year
FDA+

Ot­su­ka’s AD­HD as­set suc­ceeds in reg­is­tra­tional tri­als with chil­dren and teens

Last year

Sanofi shakes up clin­i­cal plans for trio of pro­grams from De­nali, Prin­cip­ia and Kymab deals

Last year
Pharma

Prime Med­i­cine show­cas­es its first in vi­vo edit­ing da­ta in mon­keys and mice

Last year
Cell/Gene Tx

Sanofi will spin out con­sumer unit, putting weight be­hind R&D ef­forts: ‘I have to in­vest in the sci­ence now’

Last year
Pharma

Mer­ck’s Keytru­da sales eclipse $18B on the year, while num­bers for Lagevrio sur­prise

Last year
Pharma

Bris­tol My­ers push­es back ‘peak’ for new prod­uct sales, cit­ing chal­leng­ing up­take for So­tyk­tu, Camzyos

Last year
Pharma

Like Mod­er­na, pan­dem­ic peers Pfiz­er and BioN­Tech head to PhI­II with Covid/flu com­bo jab

Last year
Pharma
Coronavirus

In­ject­ed form of Leqem­bi ap­pears ef­fec­tive at clear­ing amy­loid, but with no­table risks

Last year
Pharma

When treat­ing Alzheimer’s, ear­li­er is bet­ter, ac­cord­ing to analy­sis of Lil­ly and Ei­sai tri­als

Last year

‘Ex­cit­ed to be back’: Roche’s se­quel to failed Alzheimer’s an­ti­body looks promis­ing in ear­ly study

Last year

BioX­cel says in­de­pen­dent au­dit of Alzheimer’s study found mis­con­duct did not im­pact da­ta re­li­a­bil­i­ty

Last year

Bio­gen touts glimpses of ef­fi­ca­cy in ear­ly study of tau-low­er­ing drug

Last year
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