FDA+ channel feed

Bris­tol My­er­s' $9 Cel­gene CVR is tee­ter­ing on the brink of dis­as­ter as the FDA de­lays the liso-cel ap­pli­ca­tion yet again

5 years ago

Sanofi grap­ples with re­jec­tion of po­ten­tial first-in-class or­phan drug, faults third-par­ty man­u­fac­tur­ing

5 years ago

Mer­ck­'s Keytru­da nets an­oth­er ap­proval, this time in triple neg­a­tive breast can­cer. Can it catch up to Tecen­triq?

5 years ago

Bio­Marin CEO Bi­en­aimé beats a re­treat from Eu­rope, yank­ing their ap­pli­ca­tion for he­mo­phil­ia A gene ther­a­py

5 years ago
R&D

CDER's Janet Wood­cock: Phar­ma, reg­u­la­tors have lessons to learn from Covid-19

5 years ago
Coronavirus

French health prod­ucts agency yanked in­to le­gal bat­tle over birth de­fects caused by Sanofi's De­pakine

5 years ago
Pharma

Ex­pect­ed mis­takes, the need for speed, and change to come: CBER's Pe­ter Marks looks ahead

5 years ago

A few months af­ter emerg­ing from stealth, Prax­is is hand­ed a clin­i­cal hold for lead de­pres­sion drug

5 years ago
R&D

FDA hits Su­per­nus with dou­ble wham­my, hand­ing biotech a CRL and RTF on same day

5 years ago

Covid-19 roundup: With ef­fi­ca­cy da­ta in hand, BioN­Tech talks pric­ing; Brazil halts Sino­vac tri­al fol­low­ing pa­tient death

5 years ago
Coronavirus

Sweep­ing doubts aside, Eli Lil­ly beats Re­gen­eron to emer­gency OK — clear­ing low dose an­ti­body for quick roll­out

5 years ago
Coronavirus

Now that Bio­gen’s ad­u­canum­ab team and the FDA’s Bil­ly Dunn have been bat­tered by a gamut of an­gry ex­perts, the an­a­lysts are weigh­ing in

5 years ago

Ex­pert pan­el re­view on Alzheimer’s drug ad­u­canum­ab be­comes a one-day tri­al by fire as crit­ics turn their guns on Bio­gen — and the FDA

5 years ago

As­traZeneca gets a much-need­ed boost for blood thin­ner Bril­in­ta with an OK on stroke

5 years ago

The FDA's in­sid­er re­view on ad­u­canum­ab was all about pol­i­tics, not sci­ence, and it threat­ens pa­tients and the bio­phar­ma in­dus­try alike

5 years ago
Bioregnum
Opinion

Cit­ing pan­dem­ic, Sarep­ta de­fers much-an­tic­i­pat­ed DMD gene ther­a­py PhI­II, will head to reg­u­la­tors af­ter 10-per­son study

5 years ago
Cell/Gene Tx

Bris­tol My­ers hints at some prob­lems with an FDA in­spec­tion need­ed for the liso-cel OK, and the Cel­gene CVR in­vestors are pan­ick­ing

5 years ago
R&D

Bio­Marin gets its dwarfism drug in the FDA's door — but can they change reg­u­la­tors’ minds about a longer fol­low up?

5 years ago

FDA scut­tles blue­bird's ac­cel­er­at­ed plans for sick­le cell gene ther­a­py, as high­er CMC bar forces 1-year de­lay

5 years ago
Outsourcing
Cell/Gene Tx

FDA in­sid­er re­view of­fers a stel­lar en­dorse­ment for Bio­gen’s con­tro­ver­sial ad­u­canum­ab to treat Alzheimer’s — but sta­tis­ti­cal analy­sis mars the pic­ture

5 years ago

An elec­tion night bereft of an­swers quells bio­phar­ma's 'worst-case' fears — an­a­lysts

5 years ago
Pharma

The End­points poll: A large ma­jor­i­ty of bio­phar­ma ex­ecs turn thumbs down on Bio­gen's con­tro­ver­sial pitch for ad­u­canum­ab

5 years ago

With sales ris­ing and ef­fi­ca­cy ques­tions swirling, Gilead faces calls to re­lin­quish lu­cra­tive pri­or­i­ty re­view vouch­er

5 years ago
R&D

Promis­ing mR­NA tech comes with reg­u­la­to­ry, CMC headaches

5 years ago
Cell/Gene Tx
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