Sen. Joe Manchin (D-W.Va.) (Francis Chung/E&E News/POLITICO via AP Images)

Manchin plays spoil­er again, but drug pric­ing re­forms re­main on the ta­ble

West Vir­ginia De­mo­c­rat Sen. Joe Manchin has made loud and clear how much his sin­gle vote mat­ters for the Sen­ate Dems, and their even 50-50 split with Re­pub­li­cans, once again lay­ing guardrails around a rec­on­cil­i­a­tion pack­age that could pass with that sim­ple ma­jor­i­ty — thanks to VP Ka­mala Har­ris.

But for the for­mer My­lan CEO’s fa­ther, Manchin’s al­ready forged an agree­ment on drug pric­ing re­forms, which his daugh­ter’s for­mer in­dus­try group of­fi­cial­ly op­pos­es. The CBO has since pro­ject­ed the new ne­go­ti­a­tions will save the fed­er­al gov­ern­ment $288 bil­lion through 2031, a far cry from Nan­cy Pelosi’s HR 3, but could re­duce drug­mak­ers’ po­ten­tial out­put of about 1,300 to­tal drug ap­provals over 30 years by about 10 drugs.

A Manchin spokesper­son told the New York Times that he hasn’t walked away from the ne­go­ti­at­ing ta­ble but the Wash­ing­ton Post and the Times both re­port­ed last night that Manchin has de­cid­ed to cut out cli­mate and tax pro­vi­sions from the pack­age, which “dealt a crush­ing blow to Pres­i­dent Biden’s do­mes­tic agen­da, ef­fec­tive­ly rul­ing out ac­tion on any­thing be­yond pre­scrip­tion drug pric­ing and health care sub­si­dies.”

Sen­ate Dems last week un­veiled their new Medicare drug price ne­go­ti­a­tions bill, which be­gin­ning in 2026 would al­low for the ne­go­ti­a­tion of 10 el­i­gi­ble drug prices, and build up to 20 by 2029.

As news of the bill broke, com­pa­nies con­tin­ued with their typ­i­cal mid-year price in­creas­es, with dozens rais­ing 112 whole­sale ac­qui­si­tion cost, or WAC, prices. By com­par­i­son, in Ju­ly 2012, there were 397 WAC price in­creas­es, ac­cord­ing to new 46brook­lyn re­search da­ta.

More re­cent­ly, com­pa­nies have pledged to stay be­low the 10% in­crease thresh­old, and Pfiz­er on Ju­ly 1 no­tably raised three drugs more than any oth­ers so far this month, with 10% price in­creas­es for Ben­zylpeni­cillin, al­so known as peni­cillin G, blood pres­sure drug Cor­lopam, and its blood thin­ner Frag­min.

The gener­ic drug in­dus­try group, the As­so­ci­a­tion for Ac­ces­si­ble Med­i­cines and its Biosim­i­lars Coun­cil an­nounced its op­po­si­tion to the new Sen­ate pric­ing re­forms, say­ing they will in­crease risks for gener­ic and biosim­i­lar man­u­fac­tur­ers as the com­pa­nies will have “no way to know whether a brand-name drug will be se­lect­ed for ne­go­ti­a­tion or what the ne­go­ti­at­ed price may be” un­til well af­ter a copy­cat’s de­vel­op­ment would need to al­ready be­gin.

If the Sen­ate price ne­go­ti­a­tion bill pass­es, com­pa­nies that don’t com­ply with the new prices can be as­sessed penal­ties of up to $1 mil­lion per day, ac­cord­ing to the bill text. And any man­u­fac­tur­er that “know­ing­ly pro­vides” false in­for­ma­tion al­so can be sub­ject to fines of $100 mil­lion per in­frac­tion.

The Sen­ate pro­pos­al, which mir­rors the pre­vi­ous ef­forts in the Build Back Bet­ter Act, which Manchin pre­vi­ous­ly tor­pe­doed, would al­so cap se­niors’ drug costs un­der Medicare at $2,000 an­nu­al­ly, but it no­tice­ably does not in­clude a $35 month­ly cap on in­sulin costs for those with in­sur­ance, which Sen. Chuck Schumer (D-NY) has twice pledged to vote on.

The CBO yes­ter­day re­vealed that the Sen­ate in­sulin cap would cost the fed­er­al gov­ern­ment $23 bil­lion over the next decade, which came to about dou­ble what the House ver­sion would cost, ex­plain­ing:

CBO es­ti­mat­ed that H.R. 6833 would have no net ef­fect on the fed­er­al deficit over 10 years and that the in­sulin-re­lat­ed pro­vi­sions of the bill would in­crease fed­er­al deficits by $11.4 bil­lion over that pe­ri­od. This es­ti­mate for the Sen­ate leg­is­la­tion re­flects the dif­fer­ences be­tween the two bills in­clud­ing an es­ti­mat­ed in­crease in the av­er­age net price of in­sulin re­sult­ing from the cer­ti­fi­ca­tion process, an es­ti­mat­ed in­crease in Med­ic­aid spend­ing re­sult­ing from a re­duc­tion in re­bates paid by in­sulin man­u­fac­tur­ers, and changes to lim­its on cost shar­ing. The Sen­ate leg­is­la­tion al­so does not in­clude the pro­vi­sions that would de­lay im­ple­men­ta­tion of the rule re­lat­ed to man­u­fac­tur­er re­bates.

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Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

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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GSK and IQVIA launch plat­form of US vac­ci­na­tion da­ta, show­ing drop in adult rates

Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more light on vaccine data, via new transparency and general awareness.

The two companies have launched Vaccine Track, a platform intended to be used by public health officials, medical professionals and others to strengthen data transparency and display vaccination trends. According to the companies, the platform is intended to aid in increasing vaccine rates and will provide data on trends to assist public health efforts.

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Ab­b­Vie sur­veys emo­tion­al im­pact of chron­ic leukemia con­di­tion, finds 'roller coast­er' of emo­tions

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.

Sen­ate Dems cling to a sim­ple ma­jor­i­ty to pass some of the biggest drug pric­ing re­forms ever

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.