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8 December, 2025
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top stories
1. Will a biotech’s pivot away from obesity let it compete with Novartis in leukemia?
2. FDA sets higher bar for CAR-T cancer treatments, saying new entrants may need to prove superiority
3. Merck outbid three competitors in $9.2B acquisition of Cidara
4. FDA misses PDUFA review deadline for Agios' thalassemia drug
5. GSK walks away from remaining Ideaya programs, formally ending partnership
6. Biosecure makes annual defense bill, with less 'bite' for drugmakers
7. Updated: Structure Therapeutics’ obesity pill stacks up with Novo and Lilly; Ascletis also reports early results
8. Updated: Wave Life Sciences’ RNA obesity shot cuts fat and retains muscle, but appears to lag Lilly’s for now
9. Cogent’s mastocytosis drug continues momentum, helps treat sicker patients
10. Dyne says Duchenne drug succeeds in pivotal study, heads to FDA for approval
11. Kura, Syndax detail data for rival menin inhibitors as both eye earlier use in AML
12. Mirum to pay $620M for Bluejay and its hepatitis D antibody
13. BioNTech, OncoC4’s antibody more than halves risk of death in Phase 3 lung cancer trial
more stories
 
Max Bayer
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President Donald Trump threw his support behind ACIP's decision on Friday to stop recommending the hepatitis B birth dose vaccine for all infants, writing in a Truth Social post that evening that the committee "made a very good decision." He then called on HHS to review other nations' childhood vaccine schedules and "align" the US schedule accordingly. It's setting up further erosion in US vaccine policy, and could align national guidance with policies that the medical establishment warns could lead to needless death.

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Max Bayer
Pharma Reporter, Endpoints News
Amy Burroughs, Terns Pharmaceuticals CEO
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by Max Gelman

OR­LAN­DO, Fla. — In Oc­to­ber, Terns Phar­ma­ceu­ti­cals made an an­nounce­ment that seemed to run counter to every pop­u­lar sen­ti­ment in biotech: It got out of obe­si­ty to fo­cus on can­cer.

The 9.4% stock drop that day showed in­vestors' dis­ap­point­ment. But in the months since, the com­pa­ny's de­ci­sion has been more than proven to be the right one. Soon af­ter drop­ping the obe­si­ty pro­gram, it re­leased da­ta for its rare leukemia treat­ment that has more than tripled the com­pa­ny's val­ue. And it be­lieves it may be able to com­pete with an emerg­ing No­var­tis block­buster.

On Mon­day, Terns an­nounced up­dat­ed da­ta from the leukemia pro­gram, called TERN-701, show­ing that 64% of pa­tients in its tri­al hit a bench­mark known as ma­jor mol­e­c­u­lar re­sponse af­ter ear­li­er drugs stopped work­ing. The da­ta were an up­date from the re­lease in No­vem­ber, and from the Amer­i­can So­ci­ety of Hema­tol­ogy’s an­nu­al meet­ing, that helped dri­ve up the stock.

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by Zachary Brennan

New CAR-T treat­ments for can­cer will need to prove that they're bet­ter than ex­ist­ing ther­a­pies to win FDA ap­proval, the agen­cy's bi­o­log­ics chief Vinay Prasad said in a jour­nal ar­ti­cle Mon­day, rais­ing the bar on the da­ta that will be re­quired for the prod­ucts.

Prasad co-au­thored the ar­ti­cle in JA­MA with oth­er top FDA of­fi­cials in the Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search. De­vel­op­ers of new CAR-T treat­ments will need to take in­to ac­count ex­ist­ing CAR-T ther­a­pies when de­vel­op­ing a con­trol group for tri­als, and gen­er­ate ev­i­dence show­ing "su­pe­ri­or­i­ty of the in­ves­ti­ga­tion­al CAR T-cell ther­a­py com­pared with con­trol."

There are sev­en CAR-T prod­ucts ap­proved for can­cer on the mar­ket, all of which reached pa­tients based on sin­gle-arm tri­als with­out a con­trol group. Oth­ers are run­ning sin­gle-arm tri­als for CAR-Ts in rare or late-line can­cers to win full ap­provals.

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Rob Davis, Merck CEO (Photographer: Jeenah Moon/Bloomberg via Getty Images)
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by Kyle LaHucik

Cidara Ther­a­peu­tics com­mand­ed a high­ly com­pet­i­tive bid­ding war for its in­fluen­za an­tivi­ral, at­tract­ing ac­qui­si­tion pro­pos­als from four phar­ma­ceu­ti­cal com­pa­nies, ac­cord­ing to a Fri­day evening reg­u­la­to­ry fil­ing.

Mer­ck of­fered near­ly 20% more per share than the next-high­est bid­der, at $221.50 per share, in a $9.2 bil­lion deal, ul­ti­mate­ly seal­ing the deal last month with the New Jer­sey drug gi­ant.

That made it the sixth-largest biotech buy­out of the year, be­hind oth­ers such as Mer­ck’s first ma­jor deal of the year, the $10 bil­lion ac­qui­si­tion of res­pi­ra­to­ry drug­mak­er Verona Phar­ma.

Un­like the deal for Verona, Mer­ck had com­pe­ti­tion for Cidara. But Mer­ck was will­ing to play ball, par­tic­u­lar­ly as it search­es for ways to fill bil­lions of dol­lars in ex­pect­ed rev­enue loss from Keytru­da’s patent cliff lat­er this decade.

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ENDPOINTS at #ASH25
The hematology sector heads into ASH under pressure, with data that could reshape R&D strategies and investment decisions across blood disorders. Join our expert analysis of the year’s most consequential readouts. Sign up today.
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