top stories

SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

3 hours ago
Pharma
FDA+

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions ...

8 hours ago
Financing
Bioregnum

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to ...

7 hours ago
People

John­son & John­son do­nates Ebo­la vac­cine amid new out­break; Ji Xing promis­es more than $127M for Mile­stone's nasal ...

5 hours ago
News Briefing

Latest

Most read

Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the ...

14 hours ago
R&D
Coronavirus

Charles Riv­er keeps adding on to its CD­MO arm, snatch­ing up a vi­ral vec­tor play­er for a tidy $350M

5 hours ago
Deals
Manufacturing

How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up ...

5 hours ago
FDA+
Coronavirus

In­cyte keeps rolling on top­i­cal cream for JAK in­hibitor, pass­ing two PhI­II tests in vi­tili­go

5 hours ago
R&D

Days ahead of Am­gen split, Cy­to­ki­net­ics reads out post-hoc da­ta sug­gest­ing heart drug works bet­ter in sick­er pa­tients ...

7 hours ago
R&D

Patrick Soon-Sh­iong's for­mer chief sci­en­tist takes can­cer com­pa­ny pub­lic in $155M re­verse merg­er

7 hours ago
R&D
see latest stream
People

Luisa Salter-Cid joins long­time Bris­tol My­ers col­lab­o­ra­tor Paul Bion­di at Flag­ship's new drug brew­ery

5 days ago

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

5 days ago

George Golumbes­ki signs on at a Eu­ro­pean spe­cial­ist VC firm with $265M to bet on ge­net­ic dis­eases

5 days ago
Financing

A T-cell play­er with back­ing from Roche takes next big step for BiTE drugs with 'on-of­f' switch to avoid tox­i­c­i­ty

8 hours ago

Gink­go nabs $DNA, biotech's most sought af­ter tick­er, for free in sweet­en­er from NYSE

3 days ago

Lark­spur Health Ac­qui­si­tion files to go pub­lic as this year's SPAC flood surges over $14B

3 days ago
Startups

Af­ter go­ing down dif­fer­ent drug dis­cov­ery paths, Genen­tech vets re­unite at Fore­site Labs to map the 'pro­tein ...

4 days ago

A Third Rock-backed play­er charts a new course against tran­scrip­tion fac­tors. Do 'switch sites' hold the mag­ic sauce?

4 days ago

A non-opi­oid pain start­up be­lieves it can top the bupi­va­caine mar­ket — and it's think­ing in terms of weeks, not ...

4 days ago
Deals

Per­cep­tive's Chi­na up­start Lian­Bio con­tin­ues swing­ing deals, team­ing up with lead Xon­toge­ny biotech Lan­dos in IBD

9 hours ago

PerkinElmer hits the check­book again, this time dol­ing out $260M for next-gen ther­a­py bioser­vices firm

4 days ago

UP­DAT­ED: Bio­gen push­es in a fresh stack of chips and starts prep­ping a glob­al R&D game plan af­ter watch­ing the cards ...

5 days ago

All of the news, delivered with full-text to your inbox. For professionals discovering, developing, and marketing biopharmaceutical drugs.

SIGN UP NOW
Subscribe to Endpoints News

Premium storiesSee all

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

4 days ago
Financing
Bioregnum

FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

5 days ago
Pharma
FDA+

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

5 days ago
FDA+
Manufacturing

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

Last week
Financing
Bioregnum

Don't missSee all

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

2 days ago
R&D

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

2 days ago
Pharma

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; ...

2 days ago
Weekly

Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

3 days ago
R&D

Endpoints Standouts

The End­points 100 sur­vey: CEOs changed the way biotechs op­er­ate dur­ing the pan­dem­ic. Things will nev­er be the same ...

Last month
People

The CHIC in­ter­view: Stéphane Ban­cel on Mod­er­na's overnight trans­for­ma­tion, the new time­line on vac­cine de­vel­op­ment ...

Last month
People
Publisher's note

The 20(+1) un­der 40: In­side the next gen­er­a­tion of biotech lead­ers

Last month
Special

2020’s NDA list is packed with com­mer­cial firsts — from his­toric to hap­haz­ard. Have we reached a tip­ping point?

4 months ago
Special

Peer review See all

May
14

As Co­di­ak en­ters 'next phase of growth,' Jen­nifer Whel­er steps in­to CMO role; Mark Tim­ney lines up his sec­ond CEO ...

May
7

Karyopharm taps long­time Pfiz­er, Am­gen vet to steer the ship; With Mer­ck in the rearview mir­ror, Roger Perl­mut­ter ...

Apr
30

Genen­tech alum Jane Gro­gan goes start­up hop­ping from Ar­se­nal­Bio to Graphite Bio; Scott Holmes to han­dle CFO du­ties at ...

Apr
23

A pair of Bay­er ex­ecs land pro­mo­tions in the US; En­er­gized by lenzilum­ab da­ta, Hu­mani­gen taps As­traZeneca alum as CMO

Apr
16

No­vavax CFO Greg Covi­no makes a quick ex­it as lead­er­ship carousel keeps turn­ing; Kite ex­ecs fly away to a cell ...

Manufacturing channel feed

4 days ago

Mod­er­na taps in­to Aus­tralia with Covid-19 boost­er deal and the po­ten­tial for lo­cal man­u­fac­tur­ing

Ear­li­er this month, Mod­er­na an­nounced pos­i­tive da­ta from its Phase II study of a boost­er shot of its Covid-19 vac­cine, de­signed to pro­tect against the vari­ants of the virus that have. ...

READ MORE

Re­call re­port: No­vo Nordisk re­calls sam­ples of mul­ti­ple in­sulin prod­ucts af­ter stor­age screw-up

4 days ago
FDA+

In the lat­est chap­ter of Emer­gent saga, CEO Bob Kramer will ad­dress US House sub­com­mit­tee on plant woes

4 days ago
Coronavirus
latest in Manufacturing

Vac­cine mak­er North­west Bio claims it's in the home­stretch for its man­u­fac­tur­ing ex­pan­sion in the UK

4 days ago

Covid-19 man­u­fac­tur­ing roundup: Emer­gent starts clean-up ef­fort af­ter dis­as­trous Form 483; Eli Lil­ly ex­pands li­cens­es for In­di­an part­ners

4 days ago
Coronavirus

BioN­Tech ex­pands mR­NA man­u­fac­tur­ing to Sin­ga­pore as clam­or for Covid-19 vac­cine and boost­ers swells

Last week

Q&A: Ain­drea Camp­bell goes small, step­ping away from Ap­ple to head man­u­fac­tur­ing at Zymer­gen — where am­bi­tions are big

Last week
People
Outsourcing

Gold­man Sachs jumps aboard Bain-backed 503(b) com­pound­ing phar­ma­cy with a $275M debt loan to sup­ply hos­pi­tals

Last week
Financing
Outsourcing
see latest stories

Pharma channel feed

8 hours ago

No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

No­var­tis' En­tresto start­ed the ACC week­end off rough with a tri­al flop in heart at­tack pa­tients, slow­ing the drug's push in­to ear­li­er pa­tients. Now, an NIH-spon­sored study is cast­ing doubt ...

READ MORE

Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

Yesterday
R&D

In­cyte’s PD-(L)1 in­hibitor head­ed for an ODAC show­down next month

4 days ago
FDA+
latest in Pharma

As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

Yesterday
R&D

Pfiz­er, Bris­tol My­er­s' Eliquis flops in post-heart surgery pa­tients, spurring an 'un­ex­plained sig­nal' in cer­tain deaths

Yesterday
R&D

Third time’s the charm as Heron wins FDA nod for non-opi­oid anes­thet­ic Zyn­relef

4 days ago
FDA+

Pfiz­er calls pro­posed IP waiv­er for Covid vac­cines a 'dis­trac­tion' from find­ing re­al so­lu­tions on ac­cess

5 days ago
Coronavirus

Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

5 days ago
see latest stories

R&D channel feed

3 days ago

BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Bio­med­ical Ad­vanced Re­search and De­vel­op­ment Au­thor­i­ty is cool­ing its jets in look­ing for new, po­ten­tial Covid-19 treat­ments, at least in the near term.

READ MORE

Gene ther­a­py play­er turned kid­ney spe­cial­ist Ve­ra drops a dud in lead­up to Nas­daq, pric­ing well be­low range

3 days ago

Kept an ocean away from its sci­en­tif­ic ad­vi­sors, Shang­hai's Elpi­science keeps up the clin­i­cal progress, re­fu­els for ...

3 days ago
latest in R&D

Pfiz­er pub­lish­es clin­i­cal tri­al di­ver­si­ty da­ta from past decade, show­ing there's much work to be done

3 days ago

Weeks af­ter Keytru­da CRL in high-risk TNBC, Mer­ck claims a win af­ter da­ta ma­ture. How soon will it re­turn to FDA?

4 days ago

Am­gen, As­traZeneca bol­ster their case for break­through asth­ma pro­gram as FDA con­sid­ers tak­ing up a re­view

4 days ago

Bay­er claims an­oth­er win on its CKD and di­a­betes hope­ful, though the ques­tion re­mains over just how big it is

Last week

Io­n­is scraps CF pro­gram in an­oth­er set­back for the dis­ease and the com­pa­ny

Last week
see latest stories

FDA+ channel feed

4 days ago

UP­DAT­ED: In­ter­nal Trump-era emails re­veal a pletho­ra of celebs, com­pa­nies vy­ing for FDA’s at­ten­tion

The FDA on Thurs­day pub­licly re­leased a trove of about 500 pages of in­ter­nal and heav­i­ly redact­ed emails, show­ing how celebri­ties like Dr. Oz and Lau­ra In­gra­ham vied for the FDA’s ...

READ MORE

Brazil­ian Covid vari­ant in Illi­nois leads to a pause in ship­ments of Lil­ly’s mAb com­bo

4 days ago
Coronavirus

UP­DAT­ED: Apel­lis bags FDA nod for Soliris chal­lenger with a dif­fer­ent path­way to PNH — but can it slay the gi­ant?

2 days ago
latest in FDA+

UP­DAT­ED: Feds charge an­oth­er CRO staffer with fak­ing da­ta in a Glax­o­SmithK­line pe­di­atric asth­ma study

5 days ago
Outsourcing

Opin­ion: Ado­les­cents can wait. The US needs to start do­nat­ing Covid-19 vac­cines to needy coun­tries now.

6 days ago
Opinion

RWE up­start maps a new glob­al plan as in­vestors pour in the lat­est mega-round

6 days ago
Financing

Biden ad­min­is­tra­tion sig­nals that FDA may al­low abor­tion pill ac­cess via mail even af­ter the pan­dem­ic

Last week

UP­DAT­ED: EMA safe­ty com­mit­tee seeks more in­fo on heart in­flam­ma­tion fol­low­ing Pfiz­er Covid-19 vac­cine

Last week
Coronavirus
see latest stories