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1. Drugmakers with White House MFN deals claim exemption from proposed Medicare pricing tests
2. Updated: Pfizer discloses patient death in Hympavzi hemophilia trial
3. Novo Nordisk eyes a strong launch with FDA approval of obesity pill
4. Neurocrine’s Ingrezza flunks pivotal study in dyskinetic cerebral palsy
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Alexis Kramer
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Alexis Kramer
Editor, Endpoints News
1
by Max Bayer

Com­pa­nies that have vol­un­tar­i­ly agreed to drug pric­ing deals with the White House ap­pear to be ex­empt from two new CMS demon­stra­tion pro­grams that have drawn con­ster­na­tion from phar­ma in­dus­try groups.

A Jef­feries an­a­lyst note pub­lished Mon­day said that five drug­mak­ers with “most fa­vored na­tion” deals with the gov­ern­ment — Lil­ly, No­var­tis, Mer­ck, Gilead and Bris­tol My­ers Squibb — told the bank they're ex­empt from the pro­posed Medicare pric­ing demos re­leased last week.

End­points News reached out to all 14 com­pa­nies that have vol­un­tar­i­ly agreed to drug pric­ing deals with the White House and heard back from half by the time of pub­lish­ing. A spokesper­son for Mer­ck con­firmed the note was ac­cu­rate, while rep­re­sen­ta­tives for Gilead and Roche-owned Genen­tech said they won't be sub­ject to fu­ture pric­ing man­dates. A spokesper­son said GSK ex­pects to be ex­empt­ed from the pro­posed demos. No­vo Nordisk, Sanofi and Eli Lil­ly de­clined to com­ment.

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2
by Elizabeth Cairns

A pa­tient in Pfiz­er’s tri­al of its he­mo­phil­ia drug Hym­pa­vzi died from a throm­bot­ic stroke, the drug­mak­er said Mon­day.

Pfiz­er said it had in­formed reg­u­la­tors and in­ves­ti­ga­tors of the death. In a state­ment emailed to End­points News, it said that it didn’t “an­tic­i­pate any im­pact to safe­ty” for pa­tients giv­en Hym­pa­vzi.

Pfiz­er said the pa­tient died af­ter ex­pe­ri­enc­ing a stroke orig­i­nat­ing in the ar­ter­ies that pro­vide blood to the brain and spine, fol­lowed by cere­bral he­m­or­rhage. Ac­cord­ing to a state­ment from the Eu­ro­pean Haemophil­ia Con­sor­tium, the per­son died on Dec. 14.

The con­sor­tium is a Eu­ro­pean pa­tient group for peo­ple with bleed­ing dis­or­ders. While it didn’t say how it knew the added in­for­ma­tion, pa­tient and physi­cian groups of­ten re­ceive in­for­ma­tion from drug­mak­ers when there is a safe­ty is­sue in a tri­al.

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3
by Elizabeth Cairns

No­vo Nordisk has won US ap­proval of the first oral treat­ment for obe­si­ty in more than a decade.

The Dan­ish drug­mak­er’s obe­si­ty pill was ap­proved by the FDA on Mon­day. It is an oral form of No­vo’s block­buster weight loss shot We­govy, and could al­low No­vo to reach a new pop­u­la­tion of pa­tients who pre­fer not to take in­jec­tions. No­vo has al­ready reached a deal with the US gov­ern­ment, which will see the starter dose go on sale at $150 per month.

Weight loss pills have a long and ig­no­ble his­to­ry, from dan­ger­ous prod­ucts like am­phet­a­mines in the 60s and fen-phen in the 90s to much safer, though not huge­ly ef­fec­tive, pills like Vivus’s Qsymia and Orex­i­gen’s (lat­er Nal­pro­pi­on's) Con­trave in the 2010s.

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4
by Ayisha Sharma

Neu­ro­crine Bio­sciences’ In­grez­za has failed a late-stage tri­al in a type of cere­bral pal­sy, adding to a spate of clin­i­cal dis­ap­point­ments for the biotech in re­cent years.

Neu­ro­crine did not im­me­di­ate­ly re­spond to an End­points News query about whether it would con­tin­ue to de­vel­op the drug or not.

In­grez­za missed the pri­ma­ry and key sec­ondary end­points in a place­bo-con­trolled Phase 3 study called KINECT-DCP, ac­cord­ing to a Mon­day re­lease. The tri­al’s pri­ma­ry end­point looked at In­grez­za’s abil­i­ty to re­duce a type of in­vol­un­tary move­ment called chorea. KINECT-DCP en­rolled 86 chil­dren and adults with dys­k­i­net­ic cere­bral pal­sy (DCP) who have chor­eiform move­ments.

Neu­ro­crine did not share de­tailed re­sults, but said it will do so at a fu­ture med­ical meet­ing.

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