FDA com­mish Hahn spot­lights Oct 22 vac­cine ad­vi­so­ry meet­ing as the next big flash­point in the Covid-19 cam­paign

3 years ago
Bioregnum
Coronavirus

Mod­er­na takes one more step along the high-wire act of Covid-19 vac­cine work, of­fer­ing mark­ers of suc­cess for the most vul­ner­a­ble age group

3 years ago
R&D
Coronavirus

Vivek Ra­maswamy’s Der­ma­vant team looks to take on Am­gen’s $13.4B pso­ri­a­sis con­tender Ote­zla with a promis­ing PhI­II read­out for a top­i­cal ri­val

3 years ago
R&D

Covid-19 roundup: Eu­ro­pean vac­cines lob­by push­ing for li­a­bil­i­ty pro­tec­tion; VBI vac­cines to prep hu­man tri­als

3 years ago
Coronavirus

No­var­tis finds a third-gen­er­a­tion scion to an ag­ing Gleevec, suc­cess­ful­ly tak­ing on a Pfiz­er ri­val for last-chance CML pa­tients

3 years ago
R&D

Agios just sold off the roy­al­ty rights for $255M, but Bris­tol My­ers says Id­hi­fa was a bust in PhI­II. Now what?

3 years ago
R&D

Covid-19 roundup: Bio­gen con­fer­ence is tied to tens of thou­sands of Covid-19 cas­es; FDA chief Stephen Hahn walks back plas­ma com­ments

3 years ago
Coronavirus

Ex­clu­sive: We asked for bio­phar­ma's opin­ion about the plas­ma EUA. The in­dus­try of­fered a dou­ble-bar­reled re­sponse

3 years ago
FDA+
Coronavirus

Bris­tol My­ers hun­kers down at the deals ta­ble, ex­e­cut­ing a new I/O play in biotech buy­out

3 years ago
Deals

Which big bio­phar­ma play­er should gam­ble $34B on a ripe rare-dis­ease M&A tar­get? An ac­tion-hun­gry top an­a­lyst fills in the blanks

3 years ago
Deals

Covid-19 roundup: No­vavax be­gins PhII tri­al in US and Aus­tralia; As­traZeneca signs US man­u­fac­tur­ing deal with Catal­ent

3 years ago
Coronavirus

Trump her­alds a 'his­toric break­through' in the R&D fight against Covid-19 — now comes the in­stant back­lash as the FDA pro­vides a con­tro­ver­sial as­sist

3 years ago
FDA+
Coronavirus

How big is the 2020 biotech IPO boom? More than $11 bil­lion big among the year's four dozen en­trants

3 years ago
Financing

Covid-19 roundup: J&J plans 60,000-per­son PhI­II for Sep­tem­ber; Pe­ter Marks draws a red line

3 years ago
Coronavirus

De­railed gene ther­a­py study re­ports 3rd death as safe­ty and dura­bil­i­ty is­sues cloud a boom­ing field

3 years ago
R&D
Cell/Gene Tx

Bris­tol My­ers joins the lab rush in Cam­bridge with plans to con­sol­i­date R&D ops in a biotech cam­pus now un­der con­struc­tion

3 years ago
Pharma

Covid-19 roundup: Pfiz­er/BioN­Tech spell out PhI­II pri­or­i­ty; Le­gal ex­perts urge FDA to re­frain from vac­cine EUAs

3 years ago
Coronavirus

In an­oth­er shock­er, FDA re­jects Bio­Marin’s he­mo­phil­ia A gene ther­a­py, de­mand­ing more da­ta on dura­bil­i­ty

3 years ago
R&D
FDA+

J&J inks in­dus­try's lat­est bolt-on buy­out with $6.5B deal to ac­quire Mo­men­ta, beef­ing up its au­toim­mune pipeline

3 years ago
Deals

FDA hands Gilead a stun­ning re­jec­tion for block­buster RA can­di­date fil­go­tinib, deal­ing CEO O’Day a ma­jor set­back

3 years ago
R&D
FDA+

My­lan wins ear­ly FDA OK of a Tec­fidera knock­off, and they're launch­ing with an eye to top­pling Bio­gen's block­buster fran­chise

3 years ago
R&D
FDA+

An MD An­der­son study points to an­oth­er use for No­var­tis’ GSK-born can­cer drugs

3 years ago
R&D

Eli Lil­ly is bet­ting $1B-plus that it can make yet an­oth­er PD-1 drug a hit in the US. How about a deep dis­count this time?

3 years ago
R&D

Covid-19 roundup: In­side CTAP: 270 tri­als un­der­way, 570+ in the FDA line; WHO chief calls out 'vac­cine na­tion­al­is­m'

3 years ago
Coronavirus
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