Bio­phar­ma sup­ply chain se­cu­ri­ty: FDA guid­ance spells out new ex­pec­ta­tions

Last year
FDA+

A ma­jor reshuf­fling at the FDA opened the road for Bio­gen’s Alzheimer’s drug. Can it cross the fin­ish line?

Last year
FDA+

Ex­clu­sive: Helsinn chief Ric­car­do Braglia spells out a block­buster plan to take the fam­i­ly phar­ma pub­lic — with an eye on new can­cer drug deals, spin­out

Last year
Financing
Bioregnum

Five an­a­lyt­ics firms launch RWE lob­by­ing group to press Con­gress, FDA on guid­ance, Cures 2.0

Last year
FDA+

‘In­ac­cu­ra­cies’ push FDA to re­verse Trump-era ter­mi­na­tion of its Un­ap­proved Drugs Ini­tia­tive

Last year
Pharma
FDA+

Hunt­ing a T-cell cure for sol­id tu­mors, Rick Klaus­ner’s Lyell steers to Nas­daq — with big dreams and fresh for­tunes on the line

Last year
Financing

FDA clos­es the door on EUA re­quests for some fu­ture Covid-19 vac­cines

Last year
FDA+
Coronavirus

Re­searchers in biotech, acad­e­mia and Big Phar­ma are of­fer­ing puz­zle pieces to crack CAR-T for sol­id tu­mors. Will they ever snap to­geth­er?

Last year
Cell/Gene Tx
In Focus

FDA may re­quire bis­pe­cif­ic an­ti­bod­ies to be com­pared with mono­spe­cif­ic prod­ucts

Last year
R&D
FDA+

In­side Ver­tex 3.0: Can Resh­ma Ke­wal­ra­mani re­peat one of biotech's biggest suc­cess sto­ries 'a­gain and again and again'?

Last year
People
In Focus

FDA+ roundup: Flur­ry of guid­ance doc­u­ments, up­dat­ed risk cri­te­ria for Covid-19 mAbs, per­son­nel moves and more

Last year
FDA+

Lega­cies: 60 bio­phar­ma pi­o­neers over 60 who helped birth a tech rev­o­lu­tion in the mak­ing

Last year
People
Special

Jim Wil­son and Tachi Ya­ma­da are at it again — launch­ing a 2nd-gen gene ther­a­py com­pa­ny with an ap­petite for risk, glob­al vi­sion and $200M to gam­ble with

Last year
Startups

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

Last year
Financing
Bioregnum

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

Last year
Financing
Bioregnum

FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

Last year
Pharma
FDA+

A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

Last year
FDA+
Manufacturing

Let’s make that $1B-plus: Abing­worth gath­ers more cash, this time for its late-stage pok­er game. And we learned that even a biotech nu­clear win­ter has its ad­van­tages

Last year
Financing
Bioregnum

FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

Last year
Pharma
FDA+

In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

Last year
Pharma
FDA+

Josh Bilenker and Jeff En­gel­man bun­dle a moth­er lode of cash for their stealthy start­up, at­tract­ing a who's who of biotech in­vestors

Last year
Startups
Bioregnum

ICH plots ma­jor over­haul of good clin­i­cal prac­tice guide­line

Last year
R&D
FDA+

Vivek Ra­maswamy and Matt Gline swoop in­to Nas­daq on the wings of Jim Mom­tazee's SPAC with a $7B-plus Roivant de­but ready to do some deals

Last year
Financing

More in­fo on drug re­view time­lines? HHS and FDA pull Trump HHS’ last-minute pledge

Last year
Pharma
FDA+
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