Sen. Joe Manchin on Sun­day de­railed Pres­i­dent Biden’s tril­lion-dol­lar spend­ing pack­age, ef­fec­tive­ly halt­ing the De­moc­rats’ best chance yet to al­low Medicare to ne­go­ti­ate drug prices, among a bevy of oth­er health-re­lat­ed pro­vi­sions tacked on­to the Build Back Bet­ter Act.

White House press sec­re­tary Jen Psa­ki, stunned by Manchin’s an­nounce­ment on Fox News, said in a state­ment: “Sen­a­tor Manchin claims that this change of po­si­tion is re­lat­ed to in­fla­tion, but the think tank he of­ten cites on Build Back Bet­ter — the Penn Whar­ton Bud­get In­sti­tute — is­sued a re­port less than 48 hours ago that not­ed the Build Back Bet­ter Act will have vir­tu­al­ly no im­pact on in­fla­tion in the short term, and, in the long run, the poli­cies it in­cludes will ease in­fla­tion­ary pres­sures.”

While the drug pric­ing pro­vi­sions in the bill may not have been the cause for the West Vir­ginia De­mo­c­rat’s de­ci­sion to rebel against his Dem peers, the an­nounce­ment puts in lim­bo not on­ly Medicare ne­go­ti­a­tions, but a cap on in­sulin costs at $35 per month, a cap on se­niors’ out-of-pock­et drug spend­ing at $2,000 per year, and oth­er pro­vi­sions like boost­ing Oba­macare sub­si­dies and clos­ing the Med­ic­aid gap in 12 states.

Sen­ate Ma­jor­i­ty Leader Chuck Schumer (D-NY) said Mon­day he would still hold a floor vote on the BB­BA ear­ly next year, but it’s un­like­ly to hit the 51 votes nec­es­sary for pas­sage with­out Manchin or any Re­pub­li­can sup­port.

And if De­moc­rats at­tempt to go the piece­meal route and push the drug pric­ing pro­vi­sions as a stand­alone bill, they’d like­ly need 60 votes to get there, mean­ing 10 Re­pub­li­cans would have to join them.

Sen. Ron Wyden (D-OR) on Sun­day quick­ly cob­bled to­geth­er a new frame­work for the BB­BA, in­clud­ing the drug pric­ing pro­vi­sions, hop­ing Manchin might be will­ing to budge. But Manchin, whose daugh­ter is the for­mer CEO of the gener­ics firm My­lan and who op­pos­es Biden’s nom­i­na­tion of Rob Califf as FDA com­mis­sion­er, didn’t of­fer any im­me­di­ate thoughts on the plan.

“Drug com­pa­nies have been mug­ging Amer­i­cans at the phar­ma­cy win­dow for too long, and there may not be an­oth­er op­por­tu­ni­ty any­time soon for De­moc­rats to put a stop to it. Fifty mil­lion se­niors in Medicare have a lot of bar­gain­ing pow­er, and it’s long past due to put it to use,” Wyden wrote.

For many strug­gling to af­ford their pre­scrip­tion drugs and in­sulin, time is of the essence.

Mindy Salan­go, a type 1 di­a­bet­ic from Mor­gan­town, WV, said in a state­ment, “With­out Build Back Bet­ter, di­a­bet­ics could still be forced to pay hun­dreds of dol­lars on in­sulin in­stead of just $35 per month. In the great­est coun­try in the world, we are not meant to beg and de­pend on the kind­ness of strangers in or­der to ob­tain in­sulin. This is ‘sur­vival of the rich­est’ and it must stop.”

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.