Sen. Joe Manchin (D-WV) (J. Scott Applewhite/AP Images)

Manchin strikes again: Rec­on­cil­i­a­tion pack­age sur­faces, with drug pric­ing re­forms ful­ly in­tact — for now

Sen. Joe Manchin (D-WV) once again found him­self in the spot­light Wednes­day evening, but this time his col­leagues seem hap­py with the re­sults.

Manchin and Sen­ate Ma­jor­i­ty leader Chuck Schumer (D-NY) struck a $740 bil­lion rec­on­cil­i­a­tion deal that will re­duce the deficit by about $300 bil­lion and now in­cludes not on­ly the pre­vi­ous­ly an­nounced CMS drug price ne­go­ti­a­tion pro­vi­sions, but al­so caps se­niors’ out of pock­et costs at $2,000 per year, and a 15% cor­po­rate min­i­mum tax for bil­lion dol­lar cor­po­ra­tions as part of a larg­er pack­age of cli­mate change and en­er­gy se­cu­ri­ty re­forms.

Pres­i­dent Joe Biden said in a state­ment last night that he sup­ports the deal, now known as the In­fla­tion Re­duc­tion Act of 2022 (read the bill text), which will re­quire every Sen­ate De­mo­c­rat to re­main on board, but won’t re­quire the help of any Re­pub­li­can votes. The goal for De­moc­rats is to have the Sen­ate pass this ver­sion be­fore the Au­gust re­cess (i.e. next Fri­day), and then for the House to re­turn to from its re­cess some­time in Au­gust and seal the deal.

The drug pric­ing pro­vi­sions re­main iden­ti­cal to the pre­vi­ous Sen­ate bill float­ed, with CMS ne­go­ti­a­tions set to be­gin in 2026 for 10 ne­go­ti­a­tion-el­i­gi­ble drugs (i.e. af­ter nine years of no com­pe­ti­tion for small mol­e­cule drugs and 13 years for bi­o­log­ics), and build­ing up to 20 drugs by 2029. Com­pa­nies that don’t com­ply would be hit with steep penal­ties.

David Ricks

The Con­gres­sion­al Bud­get Of­fice said the drug pric­ing por­tion of the pro­pos­al could low­er the fed­er­al deficit by about $288 bil­lion through 2031, and re­duce drug­mak­ers’ 1,300 to­tal drug ap­provals by about 15 drugs over the next three decades.

But drug­mak­ers are ral­ly­ing to de­feat or soft­en the mea­sure, with PhRMA host­ing a news con­fer­ence yes­ter­day in which Eli Lil­ly CEO David Ricks said he “would be shocked if the im­pact of this bill doesn’t re­sult in 15 few­er med­i­cines from Eli Lil­ly and Co. alone.”

Oth­er phar­ma CEOs have ex­pressed sim­i­lar sen­ti­ments in earn­ings calls re­cent­ly, with J&J CEO Joaquin Du­a­to telling in­vestors the ne­go­ti­a­tions will have “a sig­nif­i­cant detri­men­tal ef­fect on the abil­i­ty of the in­dus­try of the com­pa­nies to be able to in­vest in R&D and to de­vel­op new med­i­cines.”

Drug com­pa­nies al­so would be re­quired to pay re­bates if their drug prices rise faster than in­fla­tion for Medicare and pri­vate in­sur­ance, and it would re­peal a Trump-era re­bate rule, which has not tak­en ef­fect, ac­cord­ing to the Kaiser Fam­i­ly Foun­da­tion.

Vas Narasimhan

But oth­ers seem less con­cerned. No­var­tis CEO Vas Narasimhan said in his earn­ings call, “I would say in the near to midterm not a sig­nif­i­cant im­pact, over­all net of the pos­i­tives we get from the Part D re­form and, of course, the im­pact from in­fla­tion caps as well as ne­go­ti­a­tions.”

The pro­posed 15% min­i­mum cor­po­rate tax may al­so hit phar­ma and biotech com­pa­nies that have shift­ed prof­its over­seas fol­low­ing 2017 tax re­forms.

Sen. Ron Wyden (D-OR) yes­ter­day slammed com­pa­nies like Mer­ck and Ab­bott, which have seen their tax rates fall to around 10% in re­cent years. But Ari­zona De­mo­c­rat Sen. Kyrsten Sine­ma, who has pre­vi­ous­ly op­posed any tax in­creas­es, said she’s still tak­ing a look at the deal.

What’s next? The Sen­ate par­lia­men­tar­i­an has to again (Ds and Rs met last week with the par­lia­men­tar­i­an on the drug pric­ing pro­vi­sions) re­view all of the text, and Schumer is aim­ing for a vote late next week but that may be ex­tend­ed.

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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.