Sen. Joe Manchin (D-WV) (Francis Chung/E&E News/Politico via AP Images)

Schumer moves for­ward on Medicare drug price ne­go­ti­a­tions with Manch­in's sup­port — re­ports

Months af­ter Sen. Joe Manchin (D-WV) es­sen­tial­ly squashed De­moc­rats’ hopes of pass­ing the Build Back Bet­ter Act, which in­clud­ed pro­pos­als to low­er drug prices, a sec­ond at­tempt is re­port­ed­ly un­der­way that pass­es muster with all Sen­ate De­moc­rats.

First re­port­ed by Punch­bowl, Sen­ate Ma­jor­i­ty Leader Chuck Schumer (D-NY) is sub­mit­ting a po­ten­tial rec­on­cil­i­a­tion pack­age to the Sen­ate par­lia­men­tar­i­an that in­cludes an agree­ment backed by all 50 Sen­ate De­moc­rats, in­clud­ing Manchin, to al­low Medicare to ne­go­ti­ate pre­scrip­tion drug costs.

The mat­ter is now in the hands of the par­lia­men­tar­i­an, who will be­gin re­view­ing the pro­pos­al to make sure that it falls un­der the Sen­ate’s rules on rec­on­cil­i­a­tion, ac­cord­ing to Punch­bowl.

Ac­cord­ing to a sum­ma­ry of the pro­vi­sions ac­quired by Punch­bowl, the 190-page pro­pos­al in­cludes:

  • al­low­ing Medicare to be­gin ne­go­ti­at­ing on the price of pre­scrip­tion drugs start­ing next year
  • cap­ping a pa­tient’s out-of-pock­et costs at $2,000 per year
  • adding an “in­fla­tion re­bate” to cap price in­creas­es be­yond in­fla­tion
  • ac­cess to free vac­cines for se­niors

“Sen­a­tor Manchin has long ad­vo­cat­ed for pro­pos­als that would low­er pre­scrip­tion drug costs for se­niors and his sup­port for this pro­pos­al has nev­er been in ques­tion,” Manchin spokesper­son Sam Run­y­on told Busi­ness In­sid­er in a state­ment. “He’s glad that all 50 De­moc­rats agree.”

The West Vir­ginia sen­a­tor ef­fec­tive­ly de­railed a tril­lion-dol­lar spend­ing pack­age backed by Pres­i­dent Biden and De­moc­rats last year — si­mul­ta­ne­ous­ly halt­ing a bevy of health­care-re­lat­ed pro­vi­sions in the bill. Be­fore that, De­moc­rats had nev­er been so close to pass­ing ma­jor drug pric­ing re­forms.

In­dus­try group PhRMA has blast­ed the De­moc­rats’ drug pric­ing pro­pos­al, ar­gu­ing months ago that the bill would “throw sand in the gears of med­ical progress.” The group of­fered sim­i­lar crit­i­cism on Wednes­day, with PhRMA’s EVP of pub­lic af­fairs De­bra DeShong say­ing in a state­ment:

The pre­scrip­tion drug bill re­leased to­day went from bad to worse for pa­tients. De­moc­rats weak­ened pro­tec­tions for pa­tient costs in­clud­ed in pre­vi­ous ver­sions, while dou­bling down on sweep­ing gov­ern­ment price-set­ting poli­cies that will threat­en pa­tient ac­cess and fu­ture in­no­va­tions. In fact, they are propos­ing to re­peal a pol­i­cy that would have di­rect­ly low­ered costs at the phar­ma­cy for mil­lions of se­niors in fa­vor of a new price-set­ting scheme. The bill al­so ig­nores the role of mid­dle­men and in­sur­ers in de­ter­min­ing pa­tient out-of-pock­et costs. Un­for­tu­nate­ly, PBMs and in­sur­ers will con­tin­ue to ben­e­fit by shift­ing more of the cost bur­den to pa­tients when it comes to coin­sur­ance and pre­mi­um in­creas­es. Pa­tients de­serve bet­ter.

Uni­ver­si­ty of Chica­go re­searchers re­cent­ly ar­gued that Medicare ne­go­ti­a­tions would lead to a re­duc­tion of $663 bil­lion in R&D spend­ing through 2039, and 135 few­er new drug ap­provals. How­ev­er, the Con­gres­sion­al Bud­get Of­fice sug­gest­ed back in No­vem­ber that Medicare ne­go­ti­a­tions would on­ly re­sult in 10 few­er drugs (out of a cal­cu­lat­ed to­tal of 1,300 drug ap­provals) over 30 years.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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