Dem­s' $100B deal re­duced fur­ther: Medicare drug price ne­go­ti­a­tions pushed to 13 years for bi­o­log­ics

House De­moc­rats are on the cusp of pass­ing two ma­jor pieces of Biden’s agen­da Fri­day, but Medicare drug price ne­go­ti­a­tions — once the cen­ter­piece of the Build Back Bet­ter Act’s rev­enue stream — has been rel­e­gat­ed to on­ly about $100 bil­lion in sav­ings over the next decade. That num­ber fell low­er yes­ter­day.

Scott Pe­ters

Over­all, the com­pro­mise end­ed up win­ning over both De­mo­c­rat sen­a­tors re­ceiv­ing PhRMA cash, like Kyrsten Sine­ma and Bob Menen­dez, and more lib­er­al sen­a­tors, like Eliz­a­beth War­ren. But on the House side, the bat­tle con­tin­ued up un­til yes­ter­day evening.

PhRMA al­ly Rep. Scott Pe­ters (D-CA) wran­gled an­oth­er year of ex­clu­siv­i­ty for bi­o­log­ics be­fore Medicare will be able to ne­go­ti­ate prices, mean­ing ne­go­ti­a­tions will now be­gin af­ter 13 years (in­stead of 12 in the orig­i­nal text). Pe­ters’ of­fice did not con­firm the change, but a source work­ing on the ne­go­ti­a­tions con­firmed that it’s 13 years now for bi­o­log­ics.

While one year may seem slight, the move could sub­tract bil­lions in sav­ings from the deal. And such a shift would like­ly be mu­sic to the ears of Mer­ck and Bris­tol My­ers Squibb.

Mer­ck’s Keytru­da and Bris­tol My­ers Squibb’s Op­di­vo, both check­point in­hibitors and two of the biggest block­buster bi­o­log­ic can­cer drugs in the world, would now each get an ex­tra year of ne­go­ti­a­tion-free sales. Medicare Part B spent more than $4 bil­lion on the drugs com­bined in 2019, which un­der the new deal wouldn’t see ne­go­ti­a­tions from Medicare un­til 2027, as they were first FDA ap­proved in 2014.

Ac­cord­ing to the Trea­sury de­part­ment, the drug pric­ing pro­vi­sions will save about $100 bil­lion over 10 years, al­though the CBO has yet to score the fi­nal text of the bill. By com­par­i­son, the CBO scored House Speak­er Nan­cy Pelosi’s drug pric­ing bill, which passed the House twice but nev­er mus­tered any­thing in the Sen­ate, as re­duc­ing fed­er­al spend­ing by $456 bil­lion over 10 years.

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.

Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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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.

J&J and Sanofi's mul­ti­ple myelo­ma tit-for-tat con­tin­ues, as sub­cu­ta­neous Darza­lex wins com­bo ap­proval

J&J and Sanofi have gone back and forth in their multiple myeloma tug-of-war. Earlier this year, Sanofi notched an approval of Sarclisa in combination with Amgen’s Kyprolis to try to outflank the big conglomerate, but J&J is clapping back.

Wednesday afternoon, Amgen announced that the subcutaneous version of J&J’s blockbuster Darzalex is also now approved as a combo with Kyprolis and dexamethasone. The green light came through for adults with relapsed or refractory multiple myeloma who had progressed on one to three earlier lines of therapy.

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.