Out-of-pock­et cap will in­crease the net price of in­sulin, CBO tells Sen­ate bill spon­sors

A bill that would cap out-of-pock­et in­sulin costs for the in­sured at $35 per month re­mains in lim­bo as the Con­gres­sion­al Bud­get Of­fice told the two Sen­ate spon­sors of the bill that it will like­ly in­crease net prices for in­sulin, and will in­crease pre­mi­ums for com­mer­cial health in­sur­ance and Medicare Part D.

The com­ments from the CBO may spell the end for the bill, which is ef­fec­tive­ly a Band-Aid for a seg­ment of the phar­ma mar­ket that has bal­looned in re­cent years, dri­ving many to ra­tion their life-sav­ing drug.

“Spend­ing for in­sulin and oth­er phar­ma­ceu­ti­cal prod­ucts would in­crease, CBO es­ti­mates, be­cause over­all med­ica­tion use would in­crease in re­sponse to low­er cost-shar­ing re­quire­ments,” CBO di­rec­tor Phillip Swagel wrote to Sens. Jeanne Sha­heen (D-NH) and Su­san Collins (R-ME) on Fri­day. “Some use of in­sulin might al­so shift to new­er and more ex­pen­sive in­sulin prod­ucts. In­creased spend­ing for phar­ma­ceu­ti­cal prod­ucts would re­sult in in­creased spend­ing for health care over­all.”

Three drug­mak­ers con­trol the more than $20 bil­lion in­sulin mar­ket — Eli Lil­ly, No­vo Nordisk, and Sanofi — as the cur­rent price of in­sulin in the US is more than 10 times that of 33 oth­er com­pa­ra­ble coun­tries, even as the net price of in­sulin has de­clined in re­cent years.

Both Lil­ly and Sanofi pre­vi­ous­ly told End­points News that they sup­port the Sen­ate bill. And Sanofi re­cent­ly an­nounced it would match the $35 per month cap for some of its in­sulins.

Mean­while, in March, the US House of Rep­re­sen­ta­tives passed (by a vote of 232-193) gen­er­al­ly the same month­ly in­sulin cap along par­ty lines. But the CBO has since said that the Sen­ate bill would cost the fed­er­al gov­ern­ment $23 bil­lion over the next decade, which came to about dou­ble what the House ver­sion would cost.

While both the Sen­ate and the House bills ef­fec­tive­ly cut what many of those who re­ly on in­sulin to stay alive will pay at the phar­ma­cy counter, nei­ther one hits the prices set by the phar­ma man­u­fac­tur­ers, nor does it help those who are unin­sured.

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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.”

Anna Protopapas, Mersana CEO

In $1.36B biobuck deal with GSK, Mer­sana touts 'biggest pre­clin­i­cal ADC deal ever'

Days after Enhertu reeled in another FDA nod, with the first-ever green light for HER2-low breast cancer, another antibody drug conjugate biotech claims it has secured the largest preclinical ADC pact to date for a single asset.

AstraZeneca and Daiichi Sankyo made waves with their nearly $7 billion collaboration back in spring 2019, but at that point, Enhertu was already nearing the FDA’s doors with clinical data. The latest ADC tie-up to enter the biopharma fray centers around a preclinical asset, Mersana Therapeutics’ XMT-2056.

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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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.

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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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.