Scoop: Bob Nelsen is build­ing a Re­al­ly Big Neu­ro­science Com­pa­ny

6 months ago
Startups

Is 9 years too long to run a con­fir­ma­to­ry study for a drug like ad­u­canum­ab? In Sarep­ta’s case, it isn’t enough time

6 months ago
Bioregnum
R&D

Jaz­z's re­worked nar­colep­sy drug wins 7 years of or­phan ex­clu­siv­i­ty thanks to rare 'clin­i­cal su­pe­ri­or­i­ty' find­ing from FDA

6 months ago
FDA+

J&J choos­es an ad­vo­cate of the “gold­en age” of vac­cines at the Gates Foun­da­tion to lead the pipeline in­to the fu­ture

6 months ago
Coronavirus

The FDA has now poked a hor­net's nest of con­tro­ver­sy in the House. And that could sting Bio­gen's mega block­buster quest in Alzheimer's

6 months ago
Bioregnum
FDA+

House draft 2022 spend­ing bill: $86M less for FDA than what Biden re­quest­ed

6 months ago
FDA+

New DARPA-like NIH agency preps for re­al­i­ty as E&C un­veils bi­par­ti­san Cures 2.0 draft bill

7 months ago
FDA+

On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?

7 months ago
Financing
In Focus

Spring reg­u­la­to­ry agen­da: What’s com­ing soon-ish from the FDA

7 months ago
FDA+

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

7 months ago
Deals
Manufacturing

FDA’s Cavaz­zoni calls for ad­comms to ‘get back to the sub­stance’

7 months ago
FDA+

As Covid-19 shifts the world's at­ten­tion to biotech, Noubar Afeyan's Flag­ship builds $3.4B fund to fu­el new in­ven­tions. Here's the plan

7 months ago
Financing

FDA plans new stud­ies on ac­cel­er­at­ed ap­proval dis­clo­sures in bio­phar­ma ads

7 months ago
FDA+

FDA dips its toe in­to the world of pa­tient-re­port­ed out­comes for can­cer tri­als

7 months ago
R&D
FDA+

White House lays out sprawl­ing new plan to shore up phar­ma and API man­u­fac­tur­ing

7 months ago
FDA+

'Au­ton­o­my with bridges': The chief ar­chi­tect of the Alex­ion buy­out is now head­ed over to take com­mand. Here's what he's think­ing

7 months ago
Deals

Bio­phar­ma sup­ply chain se­cu­ri­ty: FDA guid­ance spells out new ex­pec­ta­tions

7 months ago
FDA+

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

7 months ago
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

7 months ago
Financing
Bioregnum

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

7 months ago
FDA+

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

7 months ago
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

7 months ago
Financing

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

7 months ago
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?

8 months ago
Cell/Gene Tx
In Focus
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