Re­pub­li­cans un­veil a drug price bill to ri­val the De­moc­rats — promis­ing low­er prices and more cures

Nan­cy Pelosi un­veiled the De­moc­rats’  drug pric­ing bill back in Sep­tem­ber and brought the fight straight to the in­dus­try with a pro­pos­al to em­pow­er the US gov­ern­ment to ne­go­ti­ate prices for se­lect drugs. Re­pub­li­cans, who de­cried the bill reeks of heavy-hand­ed gov­ern­ment in­ter­ven­tion which will sti­fle in­no­va­tion, now have a coun­ter­pro­pos­al they claim will re­sult in cheap­er drugs and in­cen­tivize R&D — fur­ther cloud­ing the prospects of a bi­par­ti­san com­pro­mise that could land on Don­ald Trump’s desk.

“On­ly one of these bills has the po­ten­tial to be­come law. While Speak­er Pelosi’s par­ti­san plan is dead on ar­rival in the Sen­ate and won’t be signed by Pres­i­dent Trump, H.R. 19 could be on Pres­i­dent Trump’s desk to­day,” said Re­pub­li­can Whip Steve Scalise in a state­ment on Mon­day. And in an ac­knowl­edg­ment that the Re­pub­li­can ef­fort would need Pelosi’s sign-off to reach a vote — a high­ly un­like­ly event — Scalise con­tin­ued, “Speak­er Pelosi must come to her sens­es. I am call­ing on her to bring H.R. 19 to the House floor for a vote this week. Amer­i­cans need a bi­par­ti­san so­lu­tion to pre­scrip­tion drug prices, not an­oth­er doomed pro­pos­al from the De­moc­rats.”

Re­pub­li­cans and De­moc­rats both ar­gue drug prices in the Unit­ed States are too high — the in­dus­try holds the crown for the least fa­vored sec­tor by Amer­i­cans, falling be­hind the fed­er­al gov­ern­ment it­self — but so far no­body can agree on just how to make the US health care sys­tem great again.

The 350-page Re­pub­li­can bill, HR19, pro­pos­es cre­at­ing the role of a ‘chief phar­ma­ceu­ti­cal ne­go­tia­tor’ at the Of­fice of the Unit­ed States Trade Rep­re­sen­ta­tive to ad­vo­cate on be­half of Amer­i­can pa­tients in trade agree­ments with re­spect to pre­scrip­tion drug prices.

In ad­di­tion, the bill seeks to lim­it an­nu­al out-of-pock­et costs for Medicare ben­e­fi­cia­ries at $3,100; caps the cost of in­sulin for se­niors in the Medicare Part D pro­gram; re­quires in­sur­ance com­pa­nies to make in­for­ma­tion about drug prices trans­par­ent at doc­tor’s of­fices so pa­tients are ap­prised of the po­ten­tial costs be­fore a pre­scrip­tion is writ­ten; and ‘stream­lines’ the reg­u­la­tion of over-the-counter prod­ucts.

Some of the pro­pos­als in HR19 al­so mir­ror poli­cies ad­vo­cat­ed by bi­par­ti­san leg­is­la­tion cur­rent­ly un­der con­sid­er­a­tion in the Sen­ate, in­clud­ing the CRE­ATES act which is de­signed to en­sure gener­ic drug­mak­ers can ac­cess brand­ed drugs to de­vel­op copy­cats, and pro­hibits “pay-for-de­lay” deals, where man­u­fac­tur­ers of brand­ed drugs main­tain their mo­nop­o­lies by of­fer­ing gener­ic com­pa­nies re­wards for de­lay­ing the launch of knock­off prod­ucts. 

The De­moc­rats’ drug pric­ing bill — HR 3, which is set to face a vote this week — could com­pel man­u­fac­tur­ers to com­ply with the prices set by the HHS, or face grave penal­ties and teth­ers the price of the some of the na­tion’s most ex­pen­sive drugs to an in­ter­na­tion­al price in­dex. Un­sur­pris­ing­ly, the bill — which promis­es to cut fed­er­al spend­ing by $345 bil­lion be­tween 2023 and 2029 — elicit­ed the ire of the in­dus­try that has so far thrived by tak­ing a lais­sez-faire ap­proach to pric­ing. Var­i­ous analy­ses have sug­gest­ed the bill, which is un­like­ly to be signed in­to law, could re­sult in be­tween 8 to 100 few­er drugs from reach­ing the mar­ket over the next decade.

A raft of Re­pub­li­can law­mak­ers is­sued state­ments sup­port­ing HR19 on Mon­day, sug­gest­ing not on­ly is HR19 su­pe­ri­or to HR3, but is far more like­ly to be signed in­to law.

“This (bill) con­tains mea­sures with bi­par­ti­san sup­port in the House and Sen­ate, can be­come law, and de­serves a vote. Mean­while, Speak­er Pelosi’s par­ti­san drug pric­ing scheme is not on­ly bad pol­i­cy, it’s nev­er go­ing to be­come law,” said the ar­chi­tects of HR19, Kevin Brady, the se­nior Re­pub­li­can on the pow­er­ful Ways and Means Com­mit­tee, along with Greg Walden (R-OR) and Vir­ginia Foxx (R-NC).

That may well be the case — the White House last week is­sued a scathing re­view of HR3, ac­cus­ing the Pelosi bill of fa­vor­ing short-term sav­ings over the “long-term cost of Amer­i­can pa­tients los­ing ac­cess to new life­sav­ing treat­ments.” But with De­moc­rats firm­ly in charge of the House of Rep­re­sen­ta­tives, HR19 faces a sim­i­lar­ly quixot­ic road to Trump’s desk, with ar­ti­cles of im­peach­ment threat­en­ing to over­shad­ow the po­lit­i­cal cal­en­dar.

Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

Am­gen launch­es the first US Hu­mi­ra biosim­i­lar at two dif­fer­ent list prices

The bizarre dynamics of the US prescription drug market were on full display once again this morning as Amgen announced that it would launch the first US biosimilar for Humira, the best-selling drug of all time, at two completely different list prices.

One price for Amgen’s Amjevita (adalimumab-atto) will be 55% below the current Humira list price, which is about $84,000 per year, and another at a list price 5% below the current Humira list price, but presumably (pharma companies don’t disclose rebates) with high rebates to attract PBMs and payers.

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Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

Credit: Shutterstock

New York City in­vests $20M in­to biotech 'in­no­va­tion space' at the Brook­lyn Navy Yard

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Dirk Thye, Quince Therapeutics CEO

Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform.

Less than a year later, Quince is pivoting again.

The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

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Richard Gonzalez, AbbVie CEO (Chris Kleponis/picture-alliance/dpa/AP Images)

Up­dat­ed: $100B+ in sav­ings? Why the in­com­ing Hu­mi­ra biosim­i­lars will take time to catch on

The 20-year reign of AbbVie’s best-selling biologic of all time — the autoimmune disease biologic Humira (adalimumab) that has brought in upwards of $200 billion during its monopoly — is coming to an end tomorrow with the launch of Amgen’s biosimilar Amjevita.

The launch comes more than four years after Europe saw the exact same competition, leading to steep discounts in price, higher uptake, and big cost savings across the board.

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A new Genentech 'MS Visibility' campaign video features Black women living with or connected to MS talking about their experiences. (Genentech)

Roche’s Genen­tech de­buts next it­er­a­tion of MS cam­paign, high­lights ex­pe­ri­ences in Black com­mu­ni­ty

Roche’s Genentech is tackling diversity in multiple sclerosis again, this time with a focus on the Black community. Its “MS Visibility” effort, debuted in 2021, is now adding to the awareness campaign with new work that includes a set of videos featuring discussions among Black women and healthcare professionals.

“They’re incredibly inspiring Black women living with or connected to MS and they’re having just honest conversation about their experience and the unique barriers that their community faces,” said Jennifer Kim, head of neuroimmunology at Genentech marketing.

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