Donald Trump. Manuel Balce Ceneta, AP

Ex­ec­u­tive or­der un­der con­struc­tion to peg US drug prices to low­est prices abroad, Trump says

As he mounts his re-elec­tion bid for 2020, pres­i­dent Don­ald Trump un­veiled plans that an ex­ec­u­tive or­der is be­ing pre­pared to im­ple­ment a “fa­vored na­tions clause” to re­duce drug prices in the Unit­ed States, in con­ver­sa­tion with re­porters on the south lawn of the White House on Fri­day.

“We’re work­ing on a fa­vored na­tions clause, where we pay what­ev­er the low­est na­tion’s price is,” Trump said. “Why should oth­er na­tions — like Cana­da — why should oth­er na­tions pay less than us?”

Trump has long lam­bast­ed the phar­ma­ceu­ti­cal in­dus­try for its pric­ing poli­cies. Af­ter cap­tur­ing the pres­i­den­cy, Trump pro­claimed drug­mak­ers were “get­ting away with mur­der.” His ad­min­is­tra­tion has since un­veiled a string of pro­pos­als to tem­per pric­ing, in­clud­ing one last year en­gi­neered to peg drug prices to over­seas rates for Medicare ben­e­fi­cia­ries. Whether this plan is the one he re­ferred to on Fri­day is un­clear.

The plan, de­signed to save Medicare more than $17 bil­lion over five years, was re­vealed in late Oc­to­ber ahead of a con­tentious mid-term bat­tle. The HHS out­lined an “in­ter­na­tion­al pric­ing in­dex (IPI)” in which prices for drugs uti­lized by Medicare — the world’s largest drug pur­chas­er — would be bench­marked against oth­er na­tions, in­stead of the way drugs are cur­rent­ly priced: by cal­cu­lat­ing the av­er­age sales price and adding 6% for the providers who man­age the drug sup­ply. Es­sen­tial­ly, in­stead of al­low­ing cheap­er drugs to be im­port­ed in­to the Unit­ed States, Trump’s ba­sic plan is to hold on to the drugs and im­port their prices.

Alex Azar HHS

This is a pi­lot pro­gram, how­ev­er, and is not be­ing primed for ex­e­cu­tion via an ex­ec­u­tive or­der. How­ev­er, to no­body’s sur­prise, the pro­pos­al elicit­ed the ire of the bio­phar­ma lob­by, and drug­mak­ers ar­gued that a num­ber of these na­tions do not ac­cept new med­i­cines due to their pric­ing poli­cies, of­ten re­strict­ing ac­cess or de­clin­ing to adopt them al­to­geth­er. An­oth­er is­sue is many drug­mak­ers aren’t par­tic­u­lar­ly forth­com­ing about the prices they set­tle on for their drugs fol­low­ing ne­go­ti­a­tions with for­eign gov­ern­ments.

A pro­pos­al re­quir­ing drug­mak­ers to di­vulge list prices in tele­vi­sion ads is set to go in­to ef­fect in the com­ing month, but many of the Trump ad­min­is­tra­tion’s oth­er drug price pro­pos­als are still be­ing ironed out.

On Ju­ly 1, HHS sec­re­tary and for­mer Eli Lil­ly ex­ec­u­tive Alex Azar sug­gest­ed the ad­min­is­tra­tion had set records by sav­ing pa­tients $26 bil­lion in gener­ic drug costs just the first year and a half of the pres­i­dent’s term. “We have al­so pro­posed that back­door re­bates in Medicare Part D, which amount­ed to $29 bil­lion last year, be de­liv­ered di­rect­ly as dis­counts to pa­tients at the phar­ma­cy counter — as soon as Jan. 1, 2020,” he wrote.

On Sat­ur­day, Trump de­clared he had gar­nered suc­cess in dri­ving down drug prices:

But the claim was read­i­ly dis­put­ed. Poli­ti­fact, owned by the non­prof­it Poyn­ter In­sti­tute for Me­dia Stud­ies, de­clared the claim “most­ly false,” cit­ing da­ta from the fed­er­al gov­ern­ment’s own data­base as well as an analy­sis pub­lished by the As­so­ci­at­ed Press in Sep­tem­ber that in­di­cat­ed that in the first nine months of 2018, there were 96 price in­creas­es for every price cut — al­though the rate of hikes is slow­ing.

Pres­i­den­tial hope­ful Bernie Sanders al­so chimed in:

Da­ta sug­gest that the Unit­ed States spends near­ly twice as much as 10 high-in­come coun­tries on health care — dri­ven by the high cost of la­bor and goods, in­clud­ing phar­ma­ceu­ti­cals and de­vices — but ac­tu­al­ly per­form worse on a num­ber of pop­u­la­tion health out­comes.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19, but follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.

Pfiz­er, Bris­tol My­er­s' Eliquis flops in post-heart surgery pa­tients, spurring an 'un­ex­plained sig­nal' in cer­tain deaths

Pfizer and Bristol Myers Squibb’s non-warfarin blood thinner Eliquis has raced out to become the most prescribed drug of its class on the market — even overtaking warfarin’s long-time lead. But in tricky-to-treat patients after a valve replacement, an investigator-sponsored study couldn’t turn up benefit and raised a troubling safety signal.

Eliquis failed to show benefit over standard of care in preventing serious clinical outcomes after a transaortic valve replacement (TAVR) and was linked to an “unexplained signal” in a subset of populations with a higher rate of non-CV deaths who did not need blood thinners apart from the surgery, according to data presented Saturday at the virtual American College of Cardiology meeting.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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In­cyte’s PD-(L)1 in­hibitor head­ed for an ODAC show­down next month

The FDA’s Oncologic Drugs Advisory Committee will spend a half day on June 24 reviewing Incyte’s PD-(L)1 inhibitor retifanlimab as a treatment for locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) for those who have progressed on or who are intolerant of platinum-based chemotherapy.

The eighth PD-(L)1 entrant in January nabbed a priority review and an orphan designation from the FDA, which sets the agency’s final decision date as July 25.