CBO warns of al­most 60 few­er new drugs over three decades with Medicare drug ne­go­ti­a­tions bill

As drug pric­ing leg­is­la­tion be­gins to gain steam on Capi­tol Hill mov­ing in­to the fall, the Con­gres­sion­al Bud­get Of­fice is of­fer­ing an up­dat­ed look at the ef­fects that House Speak­er Nan­cy Pelosi’s drug pric­ing bill, known as HR 3, would have in chill­ing bio­phar­ma R&D over 30 years.

Nan­cy Pelosi

CBO said in a new re­port Thurs­day that its up­dat­ed mod­el used to es­ti­mate the ef­fects of HR 3 would, in part, al­low for wide­spread Medicare ne­go­ti­a­tions on drug prices, lead­ing to a 15% to 25% re­duc­tion in ex­pect­ed re­turns for drugs in the top quin­tile of ex­pect­ed re­turns.

Last Feb­ru­ary, the CBO es­ti­mat­ed that Medicare ne­go­ti­a­tions un­der the same bill would re­duce prices by be­tween 57% and 75%, rel­a­tive to cur­rent prices.

The lat­est es­ti­mates could lead to 2 few­er drugs in the first decade, 23 few­er in the sec­ond decade, and 34 few­er in the third decade, CBO said. While that to­tal of 59 few­er new drugs over three decades would like­ly re­sult in the loss of mean­ing­ful new drugs, the to­tal doesn’t align with in­dus­try lob­by­ing group PhRMA’s es­ti­mate in May that HR 3 could re­duce by 90%+ the num­ber of med­i­cines de­vel­oped by small and emerg­ing biotechs, or 61 few­er drugs over 10 years.

But where­as PhRMA says such a change could threat­en ac­cess to med­i­cines, the CBO stopped short of try­ing to tease out ex­act­ly what the loss of those drugs might mean, par­tic­u­lar­ly as the FDA ap­proves plen­ty of me-too or slight­ly im­proved ver­sions of cur­rent­ly mar­ket­ed drugs each year.

“The il­lus­tra­tive pol­i­cy’s ex­act im­pli­ca­tions for the health of fam­i­lies in the Unit­ed States are un­clear. CBO has es­ti­mat­ed nei­ther which types of drugs may be af­fect­ed nor how the re­duc­tion in the num­ber of new drugs will af­fect health out­comes. In ad­di­tion, the pol­i­cy may lead to low­er prices and in­creased us­age for drugs al­ready on the mar­ket. CBO has not de­ter­mined the over­all ef­fect of the pol­i­cy on health out­comes,” the re­port says.

The re­lease of the re­port al­so comes as it seems un­like­ly that the Sen­ate will take up HR 3 in its en­tire­ty, which passed the House in 2019.

Ron Wyden

Sen­ate fi­nance com­mit­tee chair Ron Wyden (D-OR), who’s craft­ing his own leg­is­la­tion, ear­li­er this sum­mer vowed to in­clude some form of Medicare ne­go­ti­a­tions in the Sen­ate’s pack­age, which like­ly won’t need Re­pub­li­can votes to make it in­to law.

And while the CBO lays out its ex­pect­ed new drug loss­es over three decades, the gov­ern­ment agency al­so made clear how dif­fi­cult it can be to pre­dict what drugs will prove pos­i­tive in mul­ti­ple stages of clin­i­cal tri­als and win ap­proval.

“The ef­fects could be small­er if ex­pen­di­tures in late-phase hu­man tri­als are larg­er, for ex­am­ple. Al­ter­na­tive­ly, the ef­fects could be larg­er if the cost of cap­i­tal is larg­er,” the CBO said.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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President Joe Biden signs the Democrats' landmark climate change and health care bill. From L-R: Sen. Joe Manchin (D-WV), Senate Majority Leader Chuck Schumer (D-NY), House Majority Whip James Clyburn (D-SC), Rep. Frank Pallone (D-NJ) and Rep. Kathy Castor (D-FL). (Susan Walsh/AP Images)

Pres­i­dent Biden signs ma­jor drug pric­ing re­forms in­to law: What's com­ing for bio­phar­ma?

President Joe Biden yesterday afternoon signed into law historic, decades-in-the-making new drug pricing reforms as part of a wider reconciliation bill that will likely take a chunk out of biopharma companies’ profits for some blockbusters just prior to generic or biosimilar competition.

The partisan bill (all Democrats in the House and Senate voted for it, and all Republicans voted against it) includes not only Medicare price negotiations — which won’t kick off until 2026, leaving ample time for a legal challenge — but mandatory inflation-related rebates, and a $2,000 annual cap on what seniors’ pay for their prescription drugs.

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James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

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