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1. Pazdur vs. Prasad: Can the CDER-CBER dynamic change under new leadership?
2. Chinese biotechs are shedding their fast-follower reputations as innovation surges
3. WuXi AppTec plants 'flag down' in Europe with new Munich headquarters 
4. Lilly drops CVS as drug benefits manager in favor of upstart Rightway — report
5. Bayer’s pharma division makes some strides as restructuring continues
6. Exclusive: Ovid co-founder and CEO Levin plans leadership handoff in 2026
7. Alkermes' stock drops as second Phase 2 narcolepsy trial hits statistical significance — but just barely
8. Exclusive: Beacon Biosignals raises $86M to build and mine brain data trove
9. After a frenzied year of dealmaking, here’s how the PD-(L)1xVEGF bispecific race is looking so far
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Alexis Kramer
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The next two-day meeting of the CDC’s vaccine advisory panel is now scheduled to begin Dec. 4, after originally being slated for late October. Topics on the agenda will include vaccine safety, the childhood immunization schedule, and hepatitis B vaccines, according to a Federal Register notice. At the last meeting, the panel had tabled a vote on whether to postpone the hepatitis B birth dose.

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Alexis Kramer
Editor, Endpoints News
New CDER Director Richard Pazdur (L) and CBER Director Vinay Prasad
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by Zachary Brennan

FDA Com­mis­sion­er Mar­ty Makary spent hours over the week­end at Rick Paz­dur's house try­ing to con­vince the agen­cy's long­time can­cer chief to step up to the role of top drug reg­u­la­tor, a source fa­mil­iar with the mat­ter told End­points News.

Part of that dis­cus­sion in­volved Makary as­sur­ing Paz­dur that as di­rec­tor of the Cen­ter for Drug Eval­u­a­tion and Re­search, he would have au­ton­o­my and in­de­pen­dence from bi­o­log­ics di­rec­tor Vinay Prasad, ac­cord­ing to the per­son, who spoke on con­di­tion of anonymi­ty. Prasad has feud­ed with past FDA lead­ers, over­ruled CBER re­view staff, and specif­i­cal­ly tar­get­ed Paz­dur on­line be­fore Prasad's time at the FDA.

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Zai Lab's Josh Smiley (L) and Legend CEO Ying Huang at the Financial Times' Global Pharma and Biotech Summit (courtesy Financial Times)
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by Ayisha Sharma

LON­DON — Chi­na’s biotech sec­tor is steadi­ly mov­ing be­yond a “me-too” ap­proach to drug de­vel­op­ment thanks to a surge in qual­i­ty tal­ent, reg­u­la­to­ry flex­i­bil­i­ty and a lev­el of speed that’s tough to ri­val, in­dus­try ex­ec­u­tives said this week.

The sec­tor has seen more in­no­va­tion in re­cent years af­ter Chi­na adopt­ed cer­tain clin­i­cal tri­al frame­works that make it quick­er and eas­i­er for com­pa­nies to gen­er­ate key da­ta. Those changes have been par­tic­u­lar­ly ben­e­fi­cial for com­pa­nies de­vel­op­ing ex­per­i­men­tal ther­a­pies in the cell and gene ther­a­py space.

"We're prob­a­bly in­to the fourth gen­er­a­tion of biotech com­pa­nies in Chi­na now, so it's tak­en some time to evolve from 'me-too' prod­ucts," Zai Lab pres­i­dent and chief op­er­at­ing of­fi­cer Josh Smi­ley said in an in­ter­view at the Fi­nan­cial Times’ Glob­al Phar­ma and Biotech Sum­mit on Tues­day.

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WuXi AppTec US/EU President Richard Connell at the Financial Times' 2025 Global Pharma and Biotech Summit (courtesy Financial Times)
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by Anna Brown

LON­DON — WuXi AppTec is cre­at­ing its first Eu­ro­pean head­quar­ters at its ex­ist­ing fa­cil­i­ty in Ger­many, the com­pa­ny’s US and EU pres­i­dent Rick Con­nell said Wednes­day.

“The time is right now to put the flag down and say, we're here. We're here to stay,” Con­nell said dur­ing the Fi­nan­cial Times’ Glob­al Phar­ma and Biotech Sum­mit in Lon­don.

The new head­quar­ters will be lo­cat­ed at the com­pa­ny’s site in Mu­nich, which is home to its drug dis­cov­ery ser­vice sub­sidiary called Cre­lux. WuXi AppTec al­so has a sec­ond Eu­ro­pean site in Cou­vet, Switzer­land, which pro­vides ser­vices in oral sol­id dose man­u­fac­tur­ing.

“While we have big op­er­a­tions in Asia and big op­er­a­tions in the US, we've on­ly had these two sites in Eu­rope, yet we have sev­er­al hun­dred cus­tomers here in Eu­rope,” Con­nell added.

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by Max Bayer

Eli Lil­ly has dropped CVS Health as its phar­ma­cy ben­e­fit man­ag­er, se­lect­ing Right­way in­stead, ac­cord­ing to a re­port from Bloomberg News.

The out­let re­port­ed that at the be­gin­ning of the new year, Lil­ly em­ploy­ees cov­ered by the com­pa­ny’s health in­sur­ance will be au­to­mat­i­cal­ly en­rolled in Right­way’s ben­e­fits pro­gram.

A spokesper­son for Lil­ly con­firmed that it has se­lect­ed Right­way mov­ing for­ward but did not spec­i­fy which PBM Lil­ly had pre­vi­ous­ly worked with. A spokesper­son for CVS de­clined to com­ment on a spe­cif­ic cus­tomer but high­light­ed that CVS’ “over­all client re­ten­tion per­cent­age re­mains in the very high 90% range, year af­ter year. Those clients in­clude many ma­jor phar­ma­ceu­ti­cal com­pa­nies.”

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