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Writ­ing the Next Chap­ter in CLL Care: Bridg­ing Gaps Through In­no­va­tion and In­sights
top stories
1. Pinpointing the moment when biopharma sentiment finally turned
2. With backing from Pfizer and others, China startup raises $100M in new twist on licensing model
3. NICE adds further details on how the UK will pay more for drugs
4. Rapport shares updated results from Phase 2 study of seizure drug
5.
news briefing
Denali drug hold; Intercept layoffs; Capital raises for Immatics, Capricor and Protara
6.
peer review
Ex-Intercept CEO takes over at Altimmune; Carolyn Bertozzi leaves Alnylam's board
7. Praxis stops pivotal trial of rare epilepsy drug early for efficacy
8. German court stops Merck from selling subcutaneous Keytruda in patent battle with Halozyme
more stories
 
Drew Armstrong
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After much (disorganized) debate, ACIP has recommended against giving infants a dose of hepatitis B vaccine after birth. We'll have a full story on the action later as we cover the US's fast-changing approach to public health.

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Drew Armstrong
Executive Editor, Endpoints News
@ArmstrongDrew
1
by Tom Randall

In­side the two-week stretch that marked a re­ver­sal in bio­phar­ma sen­ti­ment.

Dur­ing the two weeks that our bio­phar­ma sen­ti­ment sur­vey was in the field in mid-Oc­to­ber, some­thing un­usu­al hap­pened: The mood of the in­dus­try ap­peared to snap out of its de­spair.

End­points Sig­nal sur­veyed more than 1,400 peo­ple for the Bio­phar­ma Sen­ti­ment In­dex (BP­SI) over that time. Com­ing in­to the sto­ry, many were still think­ing about 2025 as an­oth­er grind-it-out down year. At the start of our sur­vey, the sen­ti­ment read­ing hov­ered around 70, far be­low the neu­tral base­line of 100.

But over the next sev­er­al weeks, while the sur­vey was in the field, there was a sharp and con­sis­tent up­turn to­ward a much less neg­a­tive view­point.

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From L-R: OTR Therapeutics co-founders Shannon Chuai, Zhui Chen and Yuan Shi
2
by Kyle LaHucik

A new biotech has raised $100 mil­lion to build a mix of as­sets from in­side and out­side Chi­na, while de­vel­op­ing its own drug can­di­dates.

The Shang­hai-based start­up, called OTR Ther­a­peu­tics, is a new twist on West­ern in­vestors that build new com­pa­nies around Chi­nese drug can­di­dates. The com­pa­ny wants to take ad­van­tage of the rapid de­vel­op­ment and clin­i­cal work avail­able in the re­gion, but with as­sets that can come from any­where.

That ap­proach has at­tract­ed a group of glob­al back­ers, in­clud­ing Pfiz­er Ven­tures, Lil­ly Asia Ven­tures, Temasek, True Light Cap­i­tal and Sirona Cap­i­tal.

OTR has al­ready ac­quired a pre­clin­i­cal neu­rol­o­gy drug can­di­date from an un­named Chi­nese biotech, CEO Zhui Chen said in a Fri­day morn­ing in­ter­view. And it's in late-stage dis­cus­sions about two or three oth­er as­sets to bring in.

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Endpoints 100 biotech survey: It's time for the Q4 wrap to a turbulent year
Our latest survey captured the bleakest biotech outlook in a decade — but is recent momentum real or a mirage? Join us to hear what CEOs are saying about the industry’s direction. Sign up now.
3
by Anna Brown

The UK’s Na­tion­al In­sti­tute for Health and Care Ex­cel­lence (NICE) told stake­hold­ers this week that pre­vi­ous­ly re­ject­ed drugs won’t au­to­mat­i­cal­ly fall un­der its new cost-ef­fec­tive­ness thresh­old.

Fur­ther, med­i­cines cur­rent­ly un­der re­view that would now be cov­ered by the new £35,000 lim­it will have their de­ci­sions de­layed un­til April, ac­cord­ing to a Thurs­day email seen by End­points News.

Af­ter on­go­ing ne­go­ti­a­tions with the US gov­ern­ment, the UK an­nounced last week it was rais­ing its cost-ef­fec­tive­ness thresh­old for drugs by 25%. Cur­rent­ly, the up­per thresh­old lim­it is £30,000, but this will be raised to £35,000, mean­ing an ad­di­tion­al three to five drugs or la­bel ex­pan­sions will be rec­om­mend­ed per year.

It’s cur­rent­ly un­clear which drugs would ben­e­fit from this fu­ture up­date, but meet­ings are ex­pect­ed to be set af­ter April.

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Abraham Ceesay, Rapport Therapeutics CEO
4
by Ayisha Sharma

Rap­port Ther­a­peu­tics shared new da­ta from a mid-stage tri­al of its seizure drug, say­ing that it demon­strates con­sis­tent ef­fi­ca­cy over time and “across the spec­trum of dis­ease sever­i­ty.”

The re­sults build on topline re­sults re­vealed in Sep­tem­ber that showed its can­di­date, called RAP-219, cut the av­er­age num­ber of long episodes in pa­tients with fo­cal on­set seizures (FOS) by over 70% at eight weeks, as mea­sured by a de­vice im­plant­ed in the brain.

The new da­ta break down those eight weeks, show­ing a 74.7% re­duc­tion in LEs from weeks one to four and al­so from weeks five to eight.

In a more well-es­tab­lished sec­ondary end­point, RAP-219 cut the fre­quen­cy of clin­i­cal seizures by 85% from weeks one to four, and by 77.2% from weeks five to eight.