FDA so­lic­its in­dus­try in­put for OND pol­i­cy pri­or­i­ties

6 days ago
Regulatory

A top an­a­lyst spot­lights a wave of biotech star­tups look­ing to cat­a­pult on­to Nas­daq — or get bought out

6 days ago
IPOs
Venture

Pref­er­en­tial tax poli­cies com­ing for bio­phar­mas set­ting up shop in Shang­hai's newest free trade zone

6 days ago
China

Am­gen at­tor­neys win a megablock­buster patent case, deal­ing No­var­tis a se­vere set­back on biosim­i­lars play

Last week
Pharma

US sen­a­tors ac­cuse No­var­tis ex­ecs of greed for hid­ing ma­nip­u­lat­ed Zol­gens­ma da­ta — and the next step could af­fect the in­dus­try

Last week
Pharma
Regulatory

Retrophin paid Mar­tin Shkre­li 'undis­closed sum' to set­tle years­long le­gal dis­putes

Last week
People

FDA re­jects Kala's dry eye drug; Trou­bled In­sys finds a buy­er (of some as­sets) in Hik­ma

Last week
Protocols

Top Scripps sci­en­tist and biotech co-founder makes an abrupt — and un­ex­plained — ex­it

Last week
R&D

Ap­ple de­vices, in tan­dem with dig­i­tal apps, could de­tect ear­ly signs of Alzheimer's, de­men­tia: study

Last week
R&D

Melin­ta chief John John­son jumps ship — with the chair­man — from an­oth­er trou­bled an­tibi­otics play

Last week
People

Fab­ry dis­ease: FDA drafts drug de­vel­op­ment guid­ance

Last week
Regulatory

Amy Bur­roughs to lead Cleave Ther­a­peu­tics; Cyn­thia Collins clinch­es Ed­i­tas CEO job amid his­toric CRISPR move

Last week
Peer Review

As­traZeneca's flag­ship Tagris­so helps lung can­cer pa­tients live longer in piv­otal study

Last week
Pharma
R&D

Mys­tery solved? Nek­tar chief says 'soft­en­ing' in pa­tient re­spons­es to be­m­peg was a CMC is­sue — spurring a rout

Last week
R&D

The FDA de­cides to hold an ex­pert pan­el re­view of Vas­cepa af­ter all — and Amarin shares tank on un­ex­pect­ed de­lay

Last week
R&D
Regulatory

Sarep­ta shares slammed on re­port gene ther­a­py Duchenne MD pa­tient was hos­pi­tal­ized, but the com­pa­ny says it is 'er­ro­neous'

Last week
Pharma
R&D

Boris John­son pledges £250M to spur AI adop­tion in NHS; SQZ scoops CFO Teri Lox­am from Mer­ck

Last week
Protocols

New ex­ec team, new mon­ey and a big syn­di­cate — ORIC heads to PhII

Last week
R&D

Alexan­dria seals $143M deal in Seat­tle's 'heart of the heart,' grab­bing cov­et­ed land to build its biotech clus­ter

Last week
Startups

More re­search is need­ed to jus­ti­fy use of 'med­i­c­i­nal' cannabis: UK agen­cies

Last week
Regulatory

The FDA’s very pub­lic slap of No­var­tis’ red face is a warn­ing to the en­tire in­dus­try — don’t down­play it

Last week
Bioregnum

FDA Ad­Com backs Gilead­'s move to ex­pand De­scovy la­bel — but stops short of en­dors­ing broad PrEP use

Last week
Pharma
R&D

Bay­er’s $240M up­front for Blue­Rock ac­qui­si­tion puts them in the high rollers club for pre­clin­i­cal biotech buy­outs

Last week
Deals
Discovery

CMS will now cov­er pricey CAR-T ther­a­pies for Medicare pa­tients

Last week
Pharma
Regulatory
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