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1. Debate on a long-scrutinized vaccine ingredient consumes CDC panel in its second day
2. Gilead stops RSV antiviral trials after low incidence rates during recent season
3. Judge says CVS Caremark owes $95M in false claims case
4. Opus, Viatris say presbyopia drug succeeds in Phase 3
5. Novartis strikes cardiovascular discovery deal with Flagship’s ProFound
6. Altimmune posts mixed results for incretin drug in MASH; stock is halved
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Alexis Kramer
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The newly rebuilt ACIP has concluded its two-day meeting. Need a recap or want to make sense of it all? Tune into Post-Hoc Live at 3:30 p.m. ET for a conversation with Zach Brennan and Max Bayer on the panel’s priorities and the role CDC director nominee Susan Monarez might play.

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Alexis Kramer
Editor, Endpoints News
Lyn Redwood at a meeting of the Advisory Committee on Immunization Practices at the CDC (AP Photo/Shelby Lum)
1
by Max Bayer

Clin­i­cians and in­fec­tious dis­ease spe­cial­ists clashed with the ma­jor­i­ty of the CDC’s re­made vac­cine ad­vi­so­ry com­mit­tee on Thurs­day, ar­gu­ing that the pan­el’s de­bate over an in­gre­di­ent in a small num­ber of flu vac­cines was not based on ev­i­dence and risked sow­ing dis­trust.

The Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices large­ly dis­missed the con­cerns and vot­ed to rec­om­mend that all in­fluen­za vac­cines be sup­plied in sin­gle-dose vials that don’t con­tain thimeros­al. The in­gre­di­ent is used as a preser­v­a­tive in a num­ber of bi­o­log­ic prod­ucts, ac­cord­ing to the FDA.

Cody Meiss­ner, the sole for­mer mem­ber of ACIP in­clud­ed in the re­built pan­el, was the on­ly no vote. Vicky Peb­sworth ab­stained from the votes in­volv­ing thimeros­al be­cause she didn’t agree with the vot­ing lan­guage.

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2
by Kyle LaHucik

Gilead Sci­ences has ter­mi­nat­ed two Phase 2 stud­ies of an RSV treat­ment can­di­date called obelde­sivir.

The Cal­i­for­nia biotech end­ed a tri­al of the oral tablet in non-hos­pi­tal­ized adults and an­oth­er study in in­fants and chil­dren, ac­cord­ing to up­dates this week to the fed­er­al clin­i­cal tri­als data­base.

The move was the re­sult of “low­er than ex­pect­ed RSV in­ci­dence rates dur­ing the most re­cent RSV sea­son in the North­ern Hemi­sphere,” a Gilead spokesper­son said in an emailed state­ment to End­points News on Thurs­day af­ter­noon.

The low rates made it “dif­fi­cult to de­ter­mine mean­ing­ful rates of symp­tom re­duc­tion, a pri­ma­ry end­point of the study,” the spokesper­son said. The de­ci­sion wasn’t re­lat­ed to safe­ty or ef­fi­ca­cy con­cerns, they added.

A sep­a­rate Phase 2 tri­al test­ing obelde­sivir as a post-ex­po­sure pro­phy­lax­is for Mar­burg virus is “con­tin­u­ing as planned,” the spokesper­son said.

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3
by Nicole DeFeudis

A Penn­syl­va­nia fed­er­al judge ruled that CVS Care­mark owes the fed­er­al gov­ern­ment $95 mil­lion in a case that ac­cused the phar­ma­cy ben­e­fit man­ag­er of con­duct that caused Medicare to over­pay for pre­scrip­tion drugs.

Sarah Behnke, who was an ac­tu­ary in Aet­na’s Medicare de­part­ment, brought the case on be­half of the US gov­ern­ment in 2014. Her case al­leged that Care­mark “caused cer­tain health in­sur­ers to mis­rep­re­sent to the gov­ern­ment the amount they paid for pre­scrip­tion drugs on be­half of Medicare ben­e­fi­cia­ries,” ac­cord­ing to an opin­ion is­sued Wednes­day in the US Dis­trict Court for the East­ern Dis­trict of Penn­syl­va­nia.

While the US did not in­ter­vene in the case, Judge Mitchell Gold­berg ruled on Wednes­day that Behnke met her bur­den of li­a­bil­i­ty un­der some counts, but didn’t meet her bur­den re­gard­ing “fal­si­ty as to Care­mark’s Re­la­tion­ship with CVS Phar­ma­cy” and CVS Health’s li­a­bil­i­ty.

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4
by Max Gelman

Opus Ge­net­ics and Vi­a­tris' eye drug hit the pri­ma­ry end­point in a Phase 3 study, putting them on track for an FDA fil­ing by the end of the year.

The phen­to­lamine oph­thalmic so­lu­tion 0.75% pro­gram is known as MR-141. The com­pa­nies said Thurs­day that it in­duced a high­ly sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence in vi­su­al acu­ity. When do­ing an eye ex­am, more pa­tients who took MR-141 gained the abil­i­ty to see at least three more lines on an eye chart af­ter one week com­pared to those who took place­bo.

The com­pa­nies did not re­port spe­cif­ic fig­ures for the tri­al arms, but they not­ed the p-val­ue was p<0.0001.

MR-141 is a ma­jor fo­cus for the com­pa­nies, which inked a li­cens­ing agree­ment in 2022. Opus is run­ning the clin­i­cal tri­als and de­vel­op­ment, and took over that work af­ter a re­verse merg­er with Ocuphire. Vi­a­tris will han­dle com­mer­cial­iza­tion.

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5
by Elizabeth Cairns

No­var­tis has signed up pro­teomics spe­cial­ist Pro­Found Ther­a­peu­tics to pin­point “pre­vi­ous­ly un­known” pro­teins to be in­ves­ti­gat­ed as car­dio­vas­cu­lar drugs and drug tar­gets in a $25 mil­lion up­front deal.

The four-year part­ner­ship could be quite the mon­ey-spin­ner for Pro­Found. No­var­tis has agreed to mile­stone pay­ments of $750 mil­lion for each tar­get it choos­es to take for­ward, with tiered roy­al­ties po­ten­tial­ly on top.

The deal will in­volve Pro­Found, which was launched by Flag­ship Pi­o­neer­ing in 2022, to use its so-called Pro­Foundry plat­form to find nov­el pro­teins.

Pro­Foundry can “go be­yond tra­di­tion­al tar­get dis­cov­ery ap­proach­es by tap­ping in­to the vast, large­ly un­ex­plored bi­ol­o­gy of the ex­pand­ed hu­man pro­teome,” Pro­Found CEO John Lep­ore said in a Thurs­day re­lease.

The tech has a data­base of “tens of thou­sands” of new pro­tein mol­e­cules, with in­for­ma­tion on their con­nec­tiv­i­ty, func­tion­al­i­ty and ef­fects on hu­man health.

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