Sen. Joe Manchin (D-WV) at the Capitol on Friday, Dec. 17 (J. Scott Applewhite/AP Images)

Joe Manchin quash­es any im­me­di­ate hopes for ma­jor drug pric­ing re­forms

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.”

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

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 re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

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.”

FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

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.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

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.

Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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