Sen­ate De­moc­rats may have all the votes they need to pass ma­jor drug pric­ing re­form, af­ter Sen. Kyrsten Sine­ma (D-AZ) re­port­ed­ly pledged her sup­port on Thurs­day — but will they fit it in be­fore re­cess?

Sine­ma said she has agreed to “move for­ward” with the rec­on­cil­i­a­tion bill with some stip­u­la­tions, in­clud­ing the re­moval of a car­ried tax pro­vi­sion, ac­cord­ing to re­cent re­ports. The bill is still ex­pect­ed to re­duce the deficit by $300 bil­lion, and Sen. Chuck Schumer (D-NY) said that he now an­tic­i­pates “sup­port from the en­tire Sen­ate De­mo­c­ra­t­ic con­fer­ence,” the Wash­ing­ton Post re­port­ed. 

With the In­fla­tion Re­duc­tion Act, @Sen­at­eDems will:

✅Low­er en­er­gy costs and in­vest in clean en­er­gy ✅Bring down pre­scrip­tion drug prices ✅Close tax loop­holes and re­duce the deficit ✅En­sure no small busi­ness or fam­i­ly mak­ing un­der $400,000 a year will see their tax­es go up

— Chuck Schumer (@Sen­Schumer) Au­gust 4, 2022

“We have agreed to re­move the car­ried in­ter­est tax pro­vi­sion, pro­tect ad­vanced man­u­fac­tur­ing, and boost our clean en­er­gy econ­o­my in the Sen­ate’s bud­get rec­on­cil­i­a­tion leg­is­la­tion. Sub­ject to the Par­lia­men­tar­i­an’s re­view, I’ll move for­ward,” Sine­ma said in an emailed state­ment.

The bill needs sup­port from every Sen­ate De­mo­c­rat to pass, and just last week, Schumer struck a deal with hold­out Sen. Joe Manchin (D-WV). If passed, the bill would en­able Medicare ne­go­ti­a­tions and cap se­niors’ out-of-pock­et costs at $2,000 per year.

“Tonight, we’ve tak­en an­oth­er crit­i­cal step to­ward re­duc­ing in­fla­tion and the cost of liv­ing for Amer­i­ca’s fam­i­lies,” Pres­i­dent Joe Biden said in a state­ment on Thurs­day. “The In­fla­tion Re­duc­tion Act will help Amer­i­cans save mon­ey on pre­scrip­tion drugs, health pre­mi­ums, and much more.”

In­dus­try ex­ecs have blast­ed the pro­posed leg­is­la­tion, ar­gu­ing that it would chill in­no­va­tion, par­tic­u­lar­ly for small mol­e­cules.

“This is a bill that has far more neg­a­tives than it has pos­i­tives in it. And I think frankly al­though it may not be short term that chal­leng­ing from a fi­nan­cial stand­point, I think the long-term im­pli­ca­tions of this bill are pret­ty sig­nif­i­cant,” Ab­b­Vie’s CEO Rick Gon­za­lez said dur­ing the com­pa­ny’s Q2 call last week.

Pfiz­er’s CEO Al­bert Bourla said last week:

In re­al­i­ty, it’s not a price ne­go­ti­a­tion be­cause they are forc­ing their will by im­ple­ment­ing a [ 95% ] tax ac­cord­ing to pre­vi­ous guid­ance. That will cost the in­dus­try sig­nif­i­cant, we es­ti­mate $270 bil­lion over 10 years. There is a pos­i­tive pro­vi­sion there, that they are re­duc­ing the out-of-pock­et cost for the pa­tient. That’s a sig­nif­i­cant one, but it’s too lit­tle and too late.

In­dus­try trade group PhRMA CEO Stephen Ubl called the bill an “his­toric mis­take,” point­ing to re­cent Uni­ver­si­ty of Chica­go re­search which sug­gests the pro­posed leg­is­la­tion would lead to an es­ti­mat­ed 135 few­er drug ap­provals through 2039 and a $663 bil­lion drop in R&D spend­ing.

The Con­gres­sion­al Bud­get Of­fice (CBO), how­ev­er, es­ti­mat­ed the bill would re­duce drug­mak­ers’ 1,300 to­tal ap­provals by on­ly about 10 drugs over the next three decades.

Big Phar­ma is fight­ing like hell against the In­fla­tion Re­duc­tion Act—be­cause they KNOW it will LOW­ER DRUG COSTS.

Via @SenAmyK­lobuchar pic.twit­ter.com/nwKHWvwYa3

— Sen­ate De­moc­rats (@Sen­at­eDems) Au­gust 4, 2022

While the Sen­ate is out to­day, they’re re­con­ven­ing to­mor­row for a po­ten­tial vote, ac­cord­ing to Politi­co. 

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

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.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.

Want a prescription drug with that soda? While not directly possible, ads for pharma brands now running on beverage and snack cooler screens at pharmacy retailers may at least inspire customers to think about it.

OptimizeRx is hooking up with Cooler Screens media company to bring prescription drug advertising to refrigerator front doors at pharmacies including Walgreens, CVS and Kroger.

The “point of dispense” ads show a full-door image on the cooler doors when a shopper is 12 feet away, but shrinks down to a smaller banner-sized ad so that the refrigerator contents can be seen when a person gets closer. The doors — which have to be specially installed by Cooler Screens — can detect when a person is nearby, how long a person “dwells” in front of the ad and if they do or don’t open the door.

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Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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