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Con­tro­ver­sy around FDA’s Prasad ris­es again Read in browser
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1. Sanofi’s new CEO Belén Garijo gets frosty reception as Dupixent challenge awaits
2. Controversy around FDA’s Prasad rises again after Moderna rejection, behavior allegations
3. Even Europeans don't see a future in Euro biopharma anymore: Endpoints Signal
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5. In a first, one CAR-T therapy is going up directly against another in trial
6. BridgeBio's dwarfism drug succeeds in Phase 3, adding to recent late-stage wins
7. Terray says its AI model beats a popular open-source model at predicting how molecules bind with proteins
8. Utah startup Leash Bio warns AI models could 'cheat' in biology. It bets its own 'dinky' model shows the way forward
9. European VCs form coalition to garner support for homegrown biotech investing
10. Watch: Is biotech’s relationship with the FDA at a breaking point? 
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Drew Armstrong
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The Sanofi CEO job isn't an easy one. With Paul Hudson out, eyes are now on incoming chief Belén Garijo. The reception hasn't been kind, with the shares trading down and investment analysts calling the pick uninspiring, given the scope of the French drugmaker's challenges.

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Drew Armstrong
Executive Editor, Endpoints News
@ArmstrongDrew
Belén Garijo, incoming Sanofi CEO (Arne Dedert/picture alliance via Getty Images)
1
by Ayisha Sharma, Elizabeth Cairns

The neg­a­tive re­ac­tion to the im­pend­ing de­par­ture of Sanofi CEO Paul Hud­son, and Mer­ck KGaA leader Belén Gar­i­jo as his re­place­ment, is per­haps sur­pris­ing giv­en the French com­pa­ny's mut­ed per­for­mance un­der Hud­son’s lead­er­ship.

Sanofi's shares fell about 3% in Paris and 4% in New York, a cold shoul­der that may sim­ply re­flect the scale of the chal­lenge that Gar­i­jo faces when she takes the reins in late April. She’ll have less than five years be­fore the com­pa­ny’s im­muno­log­i­cal jug­ger­naut Dupix­ent goes gener­ic.

In­vestors are con­cerned Gar­i­jo doesn’t have a track record of de­liv­er­ing R&D pro­duc­tiv­i­ty at Mer­ck KGaA, Jef­feries man­ag­ing di­rec­tor Michael Leucht­en told End­points News in an in­ter­view. He con­sid­ers that crit­i­cism “a lit­tle un­fair” be­cause the Ger­man con­glom­er­ate fo­cused its cap­i­tal al­lo­ca­tion on ar­eas oth­er than phar­ma.

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2
by Zachary Brennan, Max Bayer

Vinay Prasad, the head of the FDA’s vac­cines and bi­o­log­ics of­fice, is back in the news af­ter his con­tro­ver­sial de­ci­sion to re­ject Mod­er­na’s flu vac­cine, as well as al­le­ga­tions in the Wall Street Jour­nal that he is fac­ing mul­ti­ple per­son­nel com­plaints in­side the agency.

Ac­cord­ing to the Jour­nal, Prasad has been the sub­ject of in­ter­nal com­plaints that in­clude “sex­u­al ha­rass­ment, re­tal­i­a­tion against sub­or­di­nates and ver­bal­ly be­rat­ing staff.” The Jour­nal cit­ed un­named sources, who al­so de­scribed sub­stan­tial trav­el ex­pens­es in­curred by Prasad.

A se­nior FDA leader who re­quest­ed anonymi­ty told End­points News that Prasad has as­signed cer­tain sub­or­di­nates mean­ing­less tasks and has ver­bal­ly at­tacked staff.

Prasad didn’t re­spond to a re­quest for com­ment, and HHS and FDA al­so didn’t re­spond.

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3
by Tom Randall

For much of the 20th cen­tu­ry, Eu­rope was where new med­i­cines were born. Alexan­der Flem­ing's ac­ci­den­tal dis­cov­ery of peni­cillin in a Lon­don lab­o­ra­to­ry in 1928 launched a con­ti­nent-wide en­ter­prise. In the 1970s, Eu­rope pro­duced more than twice as many new drugs as the US. In the 1990s, Eu­rope still ac­count­ed for half of glob­al R&D spend­ing.

But with the 21st-cen­tu­ry suc­cess­es of US bio­phar­ma — and the re­cent, ex­plo­sive rise of Chi­na — Eu­rope has be­come al­most an af­ter­thought. We asked near­ly 1,000 bio­phar­ma pro­fes­sion­als, with a me­di­an ex­pe­ri­ence of 16-20 years in the in­dus­try, where they’d start their ca­reer if they could do it all over again. About 58% picked the US, and 27% said Asia Pa­cif­ic (most­ly Chi­na).

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