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top stories
1. Make way, Camzyos: Cytokinetics touts promising early launch for rival heart drug
2. Gilead, Merck plan to debut new daily HIV pills
3. States sue Kennedy over US childhood vaccine overhaul
4. GSK to buy pulmonary hypertension biotech for $950M
5. Charles River sells its CDMO and European discovery businesses
6. Richard Pops to retire as Alkermes CEO, capping 35-year tenure
7. Novo Nordisk teams with Langer-founded biotech for oral obesity drugs
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Zachary Brennan
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President Donald Trump's surgeon general nominee Casey Means faced a barrage of questions today from senators on her views on vaccines. While Means did say she's supportive of vaccinations in general and that they save lives, she also did not deny the thoroughly debunked conspiracy theory that vaccines cause autism. She also initially did not comment on whether the flu vaccine reduces injuries and hospitalizations, but later said that they work at the population level.

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Zachary Brennan
Senior Editor, Endpoints News
@ZacharyBrennan
1
by Nicole DeFeudis

Cy­to­ki­net­ics ex­ec­u­tives said their first FDA-ap­proved drug is off to a strong start as it goes up against a Bris­tol My­ers Squibb ri­val in a type of heart dis­ease.

Myqor­zo launched in Jan­u­ary and will com­pete with Bris­tol My­ers’ Camzyos, which had about a four-year head start for the treat­ment of ob­struc­tive hy­per­trophic car­diomy­opa­thy. Cy­to­ki­net­ics com­mer­cial chief An­drew Cal­los told End­points News on Wednes­day that car­di­ol­o­gists are “ex­cit­ed about an­oth­er treat­ment op­tion.”

“We get a very high per­cent­age that say they plan on pre­scrib­ing Myqor­zo,” he said, cit­ing physi­cian sur­veys.

Ob­struc­tive hy­per­trophic car­diomy­opa­thy is a con­di­tion in which the heart strug­gles to pump blood. Ex­ec­u­tives on Cy­to­ki­net­ics’ fourth-quar­ter earn­ings call on Tues­day said that pa­tients start­ed treat­ment on Myqor­zo the first week it be­came avail­able. De­mand and the lev­el of en­gage­ment from health­care prac­ti­tion­ers is “at, if not above, what we ex­pect­ed in­ter­nal­ly,” Cal­los said on the in­vestor call.

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2
by Lei Lei Wu

Gilead and Mer­ck to­geth­er are de­vel­op­ing what could be the first week­ly HIV pill, but they are al­so each mak­ing an in­di­vid­ual push for new dai­ly drugs.

The two com­pa­nies sep­a­rate­ly re­port­ed find­ings Wednes­day from late-stage clin­i­cal tri­als on two new once-dai­ly pills, and plan to head to reg­u­la­tors with the da­ta.

Sin­gle-tablet treat­ments like Bik­tarvy, Gilead’s top-sell­ing drug, are al­ready avail­able, but some pa­tients can­not take them for var­i­ous rea­sons.

So Gilead is de­vel­op­ing a one-pill ther­a­py with lenaca­pavir, a mol­e­cule that’s ex­pect­ed to be a key part of the com­pa­ny’s fu­ture HIV busi­ness, though much of that fo­cus has been on lenaca­pavir’s po­ten­tial as a part of long-act­ing reg­i­mens and not the dai­ly treat­ment.

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3
by Alexis Kramer

HHS Sec­re­tary Robert F. Kennedy Jr. faces a sec­ond le­gal chal­lenge re­lat­ed to the over­haul of the child­hood vac­cine sched­ule.

Fif­teen states claimed that HHS’ de­ci­sion to down­grade rec­om­men­da­tions for six vac­cines is the “cul­mi­na­tion of a se­ries of un­law­ful ac­tions in fur­ther­ance of Sec­re­tary Kennedy’s idio­syn­crat­ic and un­sci­en­tif­ic hos­til­i­ty to vac­cines,” ac­cord­ing to a law­suit filed Tues­day.

The com­plaint, brought in a fed­er­al court in Cal­i­for­nia, fol­lows a sim­i­lar law­suit filed in Mass­a­chu­setts by lead­ing clin­i­cian groups. That court is ex­pect­ed any day to de­cide whether to pre­lim­i­nar­i­ly block the vac­cine changes.

“This is a pub­lic­i­ty stunt dressed up as a law­suit,” an HHS spokesper­son said in an emailed state­ment. “By law, the health sec­re­tary has clear au­thor­i­ty to make de­ter­mi­na­tions on the CDC im­mu­niza­tion sched­ule.”

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4
by Reynald Castaneda

GSK said on Wednes­day that it is buy­ing 35Phar­ma for $950 mil­lion, pick­ing up the Cana­di­an biotech's pul­monary hy­per­ten­sion drug pro­gram — and po­ten­tial­ly dip­ping its toes in­to in­ves­ti­gat­ing weight loss drugs that avoid mus­cle loss.

At the heart of the deal is a drug called HS235, which has com­plet­ed stud­ies in healthy sub­jects and is about to en­ter clin­i­cal tri­als. The up­com­ing tri­als will fo­cus on pul­monary ar­te­r­i­al hy­per­ten­sion (PAH) and pul­monary hy­per­ten­sion due to heart fail­ure with pre­served ejec­tion frac­tion (PH-HF­pEF).

On its web­site, 35Phar­ma de­scribes HS235 as a mul­ti­spe­cif­ic “de­coy trap” for ac­tivin and growth dif­fer­en­ti­a­tion fac­tors, which can con­tribute to PH. In this way, it ze­roes in on what’s called the ac­tivin re­cep­tor sig­nal­ing path­way, and its “en­hanced se­lec­tiv­i­ty” could re­duce bleed­ing and bro­ken blood ves­sels as side ef­fects. These are some­times seen with cur­rent PH ther­a­pies, GSK said.