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FDA approves Supernus’ Parkinson’s drug-device after two rejections Read in browser
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1. New study will try to stop Alzheimer’s decades before it begins, using experimental Eli Lilly drug
2. RFK Jr. advances out of Senate committee with Cassidy’s support
3. FDA approves Supernus’ Parkinson’s drug-device after two rejections
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Turnstone stops TIL studies; GH Research’s $150M offering
5. Flagship spinout Omega is days away from bankruptcy, filing shows
6. Regeneron will start delivering quarterly dividends 37 years into its existence
7. Astellas shakes up management despite impressive nine-month earnings
8. Updated: Pfizer sticks to 2025 projections as Covid sales stabilize, R&D revamp continues
9. Updated: Merck temporarily pauses Gardasil shipments to China following sales slowdown
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in focus
Jaimy Lee
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Ryan Cross has a great piece this morning looking at a “landmark” trial for Eli Lilly’s experimental therapy to see if it can prevent dementia in people who have the genes for inherited forms of Alzheimer’s disease. Be sure to check it out (or bookmark it for the weekend)!

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Jaimy Lee
Deputy Editor, Endpoints News
Hannah Richardson, 24, has signed up for a clinical trial that will try to prevent Alzheimer's disease (Huy Mach/WashU Medicine)
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by Ryan Cross

Alzheimer’s dis­ease has af­flict­ed Han­nah Richard­son’s fam­i­ly for gen­er­a­tions. A rare ge­net­ic mu­ta­tion, passed down from her great-grand­moth­er, has struck her rel­a­tives with the first signs of mem­o­ry loss at an av­er­age age of 39. Last year, her un­cle died with de­men­tia at 42. Her moth­er, now the same age, is in the mod­er­ate stages of the dis­ease.

Richard­son, 24, has joined a clin­i­cal tri­al hop­ing to avoid the same fate. She will be one of the youngest peo­ple ever to re­ceive an ex­per­i­men­tal drug in­tend­ed to pre­vent de­men­tia-linked amy­loid plaques from build­ing up in the first place.

“I knew im­me­di­ate­ly I want­ed to be a part of it,” she told End­points News in an in­ter­view.

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Robert F. Kennedy Jr. (AP Photo/Julia Demaree Nikhinson)
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by Max Bayer

Sen. Bill Cas­sidy (R-LA) vot­ed to ad­vance Robert F Kennedy Jr.’s nom­i­na­tion for HHS sec­re­tary to the full Sen­ate, a key show of sup­port from one of the nom­i­nee's most vo­cal crit­ics on the Re­pub­li­can side.

His de­ci­sion, part of a 14-13 com­mit­tee vote along par­ty lines, is a pos­i­tive sign for Kennedy’s prospects in a full floor vote. Fi­nance Com­mit­tee Chair­man Mike Crapo (R-ID) sig­naled last week that the larg­er Sen­ate vote could come at the end of this week.

"I’ve had very in­tense con­ver­sa­tions with Bob­by and the White House over the week­end and even this morn­ing," Cas­sidy tweet­ed ahead of the vote. "I want to thank VP JD specif­i­cal­ly for his hon­est coun­sel. With the se­ri­ous com­mit­ments I’ve re­ceived from the ad­min­is­tra­tion and the op­por­tu­ni­ty to make progress on the is­sues we agree on like healthy foods and a pro-Amer­i­can agen­da, I will vote yes."

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by Lei Lei Wu

At long last, the FDA ap­proved Su­per­nus Phar­ma­ceu­ti­cals’ Parkin­son’s dis­ease treat­ment, which will be mar­ket­ed as On­ap­go.

On­ap­go is now ap­proved to treat mo­tor fluc­tu­a­tions in adults with ad­vanced Parkin­son’s dis­ease. Pre­vi­ous­ly known as SPN-830, the ther­a­py is ad­min­is­tered us­ing a pump that con­tin­u­ous­ly de­liv­ers apo­mor­phine, a drug used to treat what’s known as “off” episodes in Parkin­son’s dis­ease. That’s when Parkin­son’s symp­toms, like stiff­ness or tremors, af­fect pa­tients be­tween dos­es of med­ica­tion such as lev­odopa.

In a Phase 3 study, On­ap­go re­duced the amount of dai­ly "off" time by 2.6 hours com­pared to 0.9 hours with place­bo at 12 weeks.

Su­per­nus said On­ap­go will be avail­able in the US in the sec­ond quar­ter of this year. The com­pa­ny did not im­me­di­ate­ly dis­close the price of the treat­ment. Its stock SUPN was up about 5% on Tues­day morn­ing.

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News Briefing: Quick hits from the biopharma web
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by ENDPOINTS

Plus, news about Au­ron Ther­a­peu­tics, Akribion Ther­a­peu­tics, En­ver­ic Bio­sciences and Va­le­rio Ther­a­peu­tics:

Turn­stone Bi­o­log­ics to dis­con­tin­ue TIL stud­ies, “re­view strate­gic al­ter­na­tives”: The com­pa­ny an­nounced it will dis­con­tin­ue stud­ies of TIDAL-01, its ex­per­i­men­tal tu­mor-in­fil­trat­ing lym­pho­cyte ther­a­py for sol­id tu­mors, and seek “strate­gic al­ter­na­tives,” such as a sale, merg­er or li­cens­ing deal. Turn­stone al­so said it is again lay­ing off staff. Back in Oc­to­ber, it laid off 60% of its work­force and sev­er­al ex­ec­u­tives stepped down. The biotech went pub­lic in Ju­ly 2023 with a $75 mil­lion ini­tial pub­lic of­fer­ing. — Lei Lei Wu

GH Re­search plans to raise $150 mil­lion: It dis­closed the pub­lic of­fer­ing af­ter shar­ing promis­ing mid-stage da­ta for its psy­che­del­ic treat­ment in some pa­tients with de­pres­sion. — Jaimy Lee

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