Rep. Porter calls on HHS in­spec­tor gen­er­al to in­ves­ti­gate FDA-Bio­gen ties pri­or to Aduhelm's ap­proval

4 years ago
Pharma
FDA+

The top 10 pipeline blowups, set­backs and sna­fus for H1 2021

4 years ago
R&D
Special

WHO signs off on IL-6 drugs to treat se­vere Covid-19 cas­es, reignit­ing pric­ing de­bate

4 years ago
Coronavirus

Start­up boast­ing 'gob­stop­per-style' vac­cine de­liv­ery draws big part­ner­ships — and back­ing from Ad­ju­vant Cap­i­tal

4 years ago
Financing
Startups

Opin­ion: The FDA's mR­NA vac­cine full ap­proval re­views are mov­ing plen­ty fast. Start the man­dates now

4 years ago
FDA+
Opinion

Guid­ance bo­nan­za: FDA, EMA, MHRA, Health Cana­da and PIC/S of­fer new ad­vice on a range of phar­ma is­sues

4 years ago
R&D
FDA+

Chemo­Cen­tryx gets new PDU­FA date af­ter ma­jor amend­ment; Nim­i­um launch­es with eye on obe­si­ty

4 years ago
News Briefing

If you thought the FDA’s ap­proval of Aduhelm for Alzheimer’s was con­tro­ver­sial, you should hear the ex­pert­s' ...

4 years ago
Pharma

Af­ter de­lay caused by Ital­ian CD­MO, No­var­tis moves man­u­fac­tur­ing to Aus­tri­an site

4 years ago
R&D
Manufacturing

Woes con­tin­ue pil­ing up for Emer­gent as man­u­fac­tur­er faces in­vestor re­volt, in­sid­er trad­ing al­le­ga­tions

4 years ago
Coronavirus
Manufacturing

Eli Lil­ly, Boehringer In­gel­heim tout piv­otal heart fail­ure win for Jar­diance, po­ten­tial­ly set­ting up a No­var­tis ...

4 years ago
R&D
Pharma

Eli Lil­ly adds a $15M eq­ui­ty sweet­en­er for its plat­form part­ner in saR­NA

4 years ago
Financing

Chi­nese health au­thor­i­ty erects new gold stan­dard in on­col­o­gy R&D, spook­ing in­vestors in boom­ing field

4 years ago
China

A fad­ed pen­ny stock play­er folds its cards and hands over the keys in re­verse merg­er

4 years ago
Deals

Down but not out: FDA re­jects Proven­tion's di­a­betes drug as com­mer­cial prod­uct dif­fers from tri­al drug

4 years ago
R&D
FDA+

No hol­i­day for biotech IPOs as Rally­bio and Sophia Ge­net­ics sub­mit their Nas­daq pitch­es

4 years ago
Financing

Covid-19 roundup: Is­rael and South Ko­rea ne­go­ti­ate vac­cine swap; Af­ter av­do­ral­imab fail­ure, In­nate aban­dons pan­dem­ic ...

4 years ago
Coronavirus

Eu­ro­pean Com­mis­sion clears As­traZeneca's $39B bid for Alex­ion and a fu­ture in rare dis­eases. Now there's just a fi­nal ...

4 years ago
Deals

Scoop: Bob Nelsen is build­ing a Re­al­ly Big Neu­ro­science Com­pa­ny

4 years ago
Startups

Watch out, Pfiz­er and Mod­er­na; An­ti-ag­ing break­through in mice?; Neu­ro for the new GSK; and more

4 years ago
Weekly

The CRO mad­ness con­tin­ues as Gold­man Sachs-backed buy­er group shells out $8.5B for Parex­el

4 years ago
Deals
R&D

Duke to host pri­vate meet­ing with pay­ers and bio­phar­ma on how to pay for Alzheimer's drugs

4 years ago
R&D
Pharma

A gene ther­a­py to re­store dam­aged tis­sue af­ter a heart at­tack clears pigs

4 years ago
R&D

Sar­to­rius buys ma­jor­i­ty stake in Ger­man man­u­fac­tur­ing play­er; Cerev­el Ther­a­peu­tics ends the week on a high note, with ...

4 years ago
News Briefing
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