President Biden in the South Court Auditorium on the White House complex (Susan Walsh/AP Images)

White House kills off ma­jor drug pric­ing re­forms as De­moc­rats fail to co­a­lesce around Medicare ne­go­ti­a­tion plan

Just be­fore de­part­ing for Eu­rope this af­ter­noon, Pres­i­dent Joe Biden made clear that ma­jor drug pric­ing re­forms are un­like­ly to cross the fin­ish line in the fi­nal $1.75 tril­lion so­cial spend­ing bill from De­moc­rats.

The an­nounce­ment is a ma­jor step back for Biden, who in Au­gust pledged that the gov­ern­ment would save hun­dreds of bil­lions from Medicare ne­go­ti­a­tions, and De­moc­rats in gen­er­al, who have tried to open up ne­go­ti­a­tions for years to no avail.

Biden on Thurs­day re­leased a frame­work to help con­gres­sion­al ne­go­tia­tors fig­ure out the fi­nal de­tails of the bill, but no­tice­ably ab­sent was any men­tion of al­low­ing Medicare to ne­go­ti­ate drug prices, which in­dus­try had fought tooth and nail to de­feat as pay-for for the Build Back Bet­ter Act.

“At the end of the day, there are not yet enough votes to get some­thing across the line that will de­liv­er what the Amer­i­can peo­ple need and ex­pect on pre­scrip­tion drugs,” a White House of­fi­cial said on a call with re­porters Thurs­day morn­ing.

Alex Law­son, ex­ec­u­tive di­rec­tor of the non­prof­it So­cial Se­cu­ri­ty Works who’s been work­ing on the ne­go­ti­a­tions, con­firmed to End­points News that Medicare ne­go­ti­a­tions are of­fi­cial­ly dead.

What the Biden frame­work does still in­clude is a re­peal of a Trump-era re­bate rule, which it ex­pects will save about $145 bil­lion as it would’ve in­creased se­niors’ drug pre­mi­ums. But the Biden ad­min­is­tra­tion could’ve re­pealed that rule with­out the help of Con­gress, and $145 bil­lion is a far cry from the CBO’s pre­vi­ous es­ti­mate that Medicare drug price ne­go­ti­a­tions would’ve saved $450 bil­lion over 10 years, based on its analy­sis of a pri­or drug pric­ing bill from House Speak­er Nan­cy Pelosi.

So who’s to blame for drop­ping the ball on ma­jor drug pric­ing re­forms? Swarms of phar­ma­ceu­ti­cal in­dus­try lob­by­ists are the big win­ners. And a hand­ful of Sen­ate De­moc­rats, like New Jer­sey Sen. Bob Menen­dez, have been re­luc­tant to come on board with Medicare ne­go­ti­a­tions as the in­dus­try has made clear that it could come at the cost of new drugs.

Sean Dick­son, drug pric­ing ex­pert at West Health, told End­points he’s still wait­ing to hear more de­tails on the penal­ties that may oc­cur when drug prices in­crease faster than the rate of in­fla­tion. Sen. Ron Wyden (D-OR), who’s spear­head­ing the drug pric­ing part of the ne­go­ti­a­tions, pre­vi­ous­ly said he se­cured agree­ment with the par­lia­men­tar­i­an on the in­clu­sion of the penal­ties.

“I’ll note that ab­sent re­forms that re­duce drug prices, 1.1M se­niors are ex­pect­ed to die pre­ma­ture­ly due to cost-re­lat­ed non-ad­her­ence over the next 10 years,” Dick­son said.

David Mitchell, a can­cer pa­tient and founder of Pa­tients For Af­ford­able Drugs Now, said in a state­ment in re­sponse to Biden’s frame­work: “The lack of pro­vi­sions to low­er drug prices in the Build Back Bet­ter frame­work is a huge fail­ure that will harm mil­lions of Amer­i­cans who are count­ing on De­moc­rats and the pres­i­dent to de­liv­er on their promis­es and pro­vide des­per­ate­ly need­ed re­lief.”

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

What's fair? New ICER re­port shows pay­ers gen­er­al­ly en­sur­ing fair ac­cess to drugs

The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.

While noting the lack of transparency hindered the report’s results, ICER said that the “great majority” of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines “fair access.”

With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

GSK 'Target the Future' Ad Campaign

Glax­o­SmithK­line's friend­ly ‘shark tank’ crowd­sources ideas for mul­ti­ple myelo­ma, kicks off big­ger push

GlaxoSmithKline is inviting everyone to its friendly shark tank. Its “Think Tank” challenge launching today aims to gather the best pitches for ideas in multiple myeloma with a final pitch-off “Shark Tank” TV show-style finish next year.

The innovation contest kicks off GSK’s bigger “Target the Future” unbranded campaign to advance innovation and awareness in multiple myeloma.

“We have a good sense of where the unmet need lies and what tools may be welcomed by this community, and we’ll continue to do that as part of this program, but the ‘Think Tank’ kickoff is to bring new ideas to the table — things that come from a more grassroots perspective than a large pharma perspective,” Christine Roth, senior VP and global head of oncology at GSK, said.

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Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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