HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

Five Pfiz­er drugs among first 27 now sub­ject to Medicare in­fla­tion re­bates, HHS says

The De­part­ment of Health and Hu­man Ser­vices (HHS) on Wednes­day un­veiled the first set of 27 Part B pre­scrip­tion drugs, in­clud­ing five from Pfiz­er, that will be sub­ject to Medicare in­fla­tion re­bates be­cause their prices rose faster than the rate of in­fla­tion.

Se­niors re­ceiv­ing the physi­cian-ad­min­is­tered drugs be­gin­ning in April will have low­er coin­sur­ance for these drugs (list­ed be­low) and HHS said they may see their out-of-pock­et costs for these drugs de­crease by as much as $390 per av­er­age dose.

“In ad­di­tion to mak­ing drug com­pa­nies pay Medicare back for in­creas­ing their prices faster than in­fla­tion, this pro­vi­sion of the In­fla­tion Re­duc­tion Act dis­cour­ages oth­er com­pa­nies from do­ing the same, with the goal of rein­ing in ex­ces­sive drug price hikes year-over-year,” the White House and CMS said in a fact sheet re­leased this morn­ing (in ad­di­tion to the ini­tial guid­ance de­tail­ing the re­quire­ments and pro­ce­dures for the Medicare Pre­scrip­tion Drug In­fla­tion Re­bate Pro­gram here).

Mov­ing for­ward, CMS said, ben­e­fi­cia­ry coin­sur­ance will be based on the in­fla­tion-ad­just­ed pay­ment amount for the fol­low­ing drugs:

Usu­al sus­pects like Ab­b­Vie’s Hu­mi­ra will be sub­ject to biosim­i­lar com­pe­ti­tion be­gin­ning this year so the price in­creas­es will like­ly come down. But for oth­er drugs with­out com­peti­tors, the price in­creas­es con­tin­ue apace, such as with Gilead sub­sidiary Kite Phar­ma’s CAR-T can­cer ther­a­py Yescar­ta.

The five Pfiz­er drugs in­clude old­er drugs like the blood thin­ner Frag­min (dal­teparin), which first won FDA ap­proval in 1994; Atgam, which is for al­lo­graft re­jec­tion in re­nal trans­plant pa­tients; and the chemo Nipent (pen­to­statin), as well as an­tibac­te­r­i­al drugs, Bi­cillin L-A and Bi­cillin C-R.

But CMS doesn’t in­tend to send the first in­voic­es to drug com­pa­nies for the 2023 and 2024 re­bates un­til 2025.

In ad­di­tion to this list, the White House al­so put out a re­port Wednes­day ex­plain­ing how se­niors will see more than $230 mil­lion in sav­ings this year when the more than 3.4 mil­lion peo­ple with Medicare be­gin to pay no out-of-pock­et costs for rec­om­mend­ed vac­cines.

“The re­port al­so shows that in some cas­es, some peo­ple paid near­ly $200 for the shin­gles vac­cine by it­self.  Again, not any­more,” said HHS Sec­re­tary Xavier Be­cer­ra on yes­ter­day af­ter­noon’s press call.

Medicare ben­e­fi­cia­ries in the Dako­tas, Mon­tana and Wyoming will see the biggest sav­ings from the IRA-re­lat­ed change re­lat­ed to no OOP costs for rec­om­mend­ed vac­cines, HHS said.

Ed­i­tor’s note: Ar­ti­cle up­dat­ed with a quote from HHS Sec­re­tary Be­cer­ra and links to the HHS and CMS re­ports and doc­u­ments.

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.”

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.

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.

J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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