Senate Finance Chair Ron Wyden (via AP Images)

Ne­go­ti­a­tions or price con­trols? Sen­ate Fi­nance Com­mit­tee splits along par­ty lines over drug prices

The now dead Build Back Bet­ter Act may be the clos­est the De­moc­rats ever get to Medicare drug price ne­go­ti­a­tions.

Al­though Sen­ate Fi­nance Chair Ron Wyden (D-OR) sought to res­ur­rect Medicare ne­go­ti­a­tions in a hear­ing on Wednes­day, Re­pub­li­cans in the com­mit­tee made clear their op­po­si­tion to ne­go­ti­at­ing, es­pe­cial­ly as they sought to con­vince view­ers that the term “ne­go­ti­a­tions” is ac­tu­al­ly clos­er to price con­trols.

“One per­son’s ne­go­ti­a­tion is an­oth­er per­son’s price con­trols,” Sen. John Cornyn (R-TX) said at the hear­ing, men­tion­ing that there’s a greater need to “beat back some of the games­man­ship from the patent sys­tem.”

He point­ed to Ab­b­Vie’s mega-block­buster RA drug Hu­mi­ra and its patent fortress, which still doesn’t have biosim­i­lar com­pe­ti­tion in the US de­spite years of com­pe­ti­tion in the EU, as an ex­am­ple of such games.

“A Medicare ne­go­ti­a­tion is just that — a process, not a price con­trol — a mar­ket-based ap­proach to come to a price be­tween pur­chas­er, Medicare and pro­duc­er,” Wyden said. He sim­i­lar­ly point­ed to the wide­ly vary­ing cost of Hu­mi­ra in dif­fer­ent coun­tries as a rea­son for such ne­go­ti­a­tions.

“As of 2020, the price per [Hu­mi­ra] pen in Que­bec, Cana­da was $563. List price in the US was $2,778,” he not­ed.

De­mo­c­rat Ben Cardin of Mary­land sim­i­lar­ly not­ed that the US is an out­lier “on what we pay, and it de­fies com­mon sense” that the fed­er­al gov­ern­ment is the largest pay­er for pre­scrip­tion drugs in the coun­try but Medicare can’t ne­go­ti­ate.

In­sulin was an­oth­er ex­am­ple cit­ed by law­mak­ers on both sides of the aisle as an ex­am­ple of drug pric­ing gone wrong, and as Pres­i­dent Biden pledged in the State of the Union to cap month­ly co-pays for in­sulin at $35.

But Re­pub­li­cans like Sen. Pat Toomey of Penn­syl­va­nia said there’s been “tremen­dous in­no­va­tion” around in­sulin, which is why the prices have risen so quick­ly.

Ac­cord­ing to HHS, the av­er­age price for a stan­dard unit of in­sulin in the US in 2018 was more than ten times the price in a sam­ple of 32 for­eign coun­tries:$98.70 in the US, com­pared with an av­er­age of $8.81 in 32 oth­er coun­tries.

Fi­nance com­mit­tee rank­ing mem­ber Mike Crapo (R-ID) and Sen. Chuck Grass­ley (R-IA) al­so sought fur­ther com­pro­mise from De­moc­rats around ne­go­ti­at­ing and ex­plained how time is of the essence to get some­thing done, es­pe­cial­ly if Re­pub­li­cans take over ei­ther the House or Sen­ate af­ter the midterms.

Sen. Steve Daines (R-MT) called on De­moc­rats to pub­licly ditch the BB­BA pro­vi­sions, and Sen. Bill Cas­sidy (R-LA) urged a re­turn to a more cen­trist, wa­tered down drug pric­ing bill from 2019, but De­moc­rats re­mained res­olute.

“With­out ne­go­ti­a­tion, the job’s not done,” Wyden said. “These com­pa­nies can charge what­ev­er they want.”

But it re­mains un­known if the De­moc­rats will be able to get it done in time, es­pe­cial­ly if they aren’t will­ing to budge around ne­go­ti­a­tions.

“When I hear gov­ern­ment price con­trols, I’m hear­ing phar­ma­ceu­ti­cal com­pa­nies be­ing afraid — this isn’t price con­trols,” Sen. Cather­ine Cortez Cas­tro (D-NM) added.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

No­var­tis un­veils 'US-first' strat­e­gy ahead of San­doz spin­off

Weeks after announcing the spinoff of generics arm Sandoz, Vas Narasimhan paints a picture of the new, slimmer Novartis — with a “US-first mindset,” he said at an investor event on Thursday.

The CEO unveiled ambitious plans to become a top-five player in the US by 2027 at Novartis’ “Meet the Management” event in Basel, Switzerland, which means ramping up clinical trials in the states and “building capability and talent, among other things.” The company’s also shooting for a top-three ranking in China.

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Pfiz­er sacks phar­ma com­pe­ti­tion in ear­ly NFL TV ad­ver­tis­ing sea­son

If pharma advertising had a fantasy football league, Pfizer would be crushing the competition. A dive into the National Football League’s TV commercial buys across early season games by iSpot shows a hefty lead with its Covid-19 Comirnaty vaccine ads.

More than 175 million impressions with $9.5 million in media spending put Pfizer in the top spot with a 65% share of voice across NFL pharma spending, according to the real-time TV ad tracker. In a distant second place is Bristol Myers Squibb’s Opdivo with 44 million impressions, $5.2 million in spending and a 16% share, followed by BMS’ Zeposia with 31 million impressions, $3.3 million in media buys and an 11% share.

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