Senate Finance committee chair Ron Wyden (D-OR)(Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate Fi­nance chair calls on Mer­ck and Ab­bott to com­ply with his in­ves­ti­ga­tion in­to their off­shore tax schemes

Sen­ate Fi­nance com­mit­tee chair Ron Wyden (D-OR) on Wednes­day sent fol­low-up let­ters to Mer­ck and Ab­bott af­ter both com­pa­nies failed to an­swer ques­tions and com­ply with his in­ves­ti­ga­tion in­to how a 2017 tax law helped slash tax rates for large, US-based phar­ma com­pa­nies thanks to shift­ing prof­its off­shore.

Last April, Wyden sent a stern let­ter to Mer­ck’s CEO and pres­i­dent Robert Davis ques­tion­ing the com­pa­ny’s abil­i­ty to go from an ef­fec­tive tax rate of 22.9% in 2020 to less than half that a year lat­er, down to 11% in 2021, thanks large­ly to Mer­ck’s use of sub­sidiaries in sev­er­al well-known low-or-ze­ro tax ju­ris­dic­tions.

For Mer­ck’s mega-block­buster can­cer drug Keytru­da, Wyden al­leged that since Mer­ck, which lob­bied heav­i­ly in fa­vor of the 2017 law, holds the IP rights to Keytru­da in the Nether­lands and man­u­fac­tures the drug en­tire­ly in Ire­land, the com­pa­ny is able to avoid bil­lions of dol­lars in tax­es in the US.

Sim­i­lar­ly, in a com­mit­tee in­ves­ti­ga­tion in­to Ab­b­Vie, which pulls in tens of bil­lions every year in the US thanks to its Hu­mi­ra mo­nop­oly that runs out in Jan­u­ary, Wyden re­veals how the 2017 law’s in­ter­na­tion­al pro­vi­sions re­ward­ed large multi­na­tion­al cor­po­ra­tions that shift prof­its over­seas.

“That Mer­ck lo­cat­ed more than 85% of its prof­its in for­eign ju­ris­dic­tions in 2021 im­plies that the cur­rent U.S. in­ter­na­tion­al tax sys­tem cre­at­ed by the 2017 Re­pub­li­can tax law has en­cour­aged and re­ward­ed Mer­ck’s shift­ing of prof­its off­shore,” Wyden wrote on Wednes­day.

He pre­vi­ous­ly re­quest­ed coun­try-spe­cif­ic in­for­ma­tion re­lat­ed to Mer­ck’s pre-tax earn­ings, prof­it mar­gins, em­ploy­ee head­count and tax paid for tax years 2018 – 2021, but the com­pa­ny de­clined to send the in­for­ma­tion.

“Un­for­tu­nate­ly, Mer­ck has twice de­clined to pro­vide the Com­mit­tee this in­for­ma­tion, choos­ing to keep se­cret how much of its prof­its are re­port­ed by off­shore sub­sidiaries for tax pur­pos­es. As not­ed in pre­vi­ous com­mu­ni­ca­tions on this mat­ter, there ap­pears to be a sub­stan­tial dis­crep­an­cy be­tween where Mer­ck gen­er­ates pre­scrip­tion drug sales and where Mer­ck books prof­its from those drug sales for tax pur­pos­es,” Wyden wrote to Mer­ck on Wednes­day.

Wyden al­so sent a let­ter Wednes­day to Ab­bott, which sim­i­lar­ly did not re­spond to re­quests for in­fo and used its for­eign ops to pay an ef­fec­tive US tax rate of 9.6% in 2019, 10% in 2020 and 13.9% in 2021, de­spite the US be­ing the com­pa­ny’s “biggest cus­tomer mar­ket and prof­it cen­ter.”

He added: “The Amer­i­can pub­lic de­serves to un­der­stand why Ab­bott, a multi­na­tion­al phar­ma­ceu­ti­cal cor­po­ra­tion with an­nu­al sales of $43 bil­lion, paid a low­er tax rate than a postal ser­vice work­er or a preschool teacher.”

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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.

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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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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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.