President Joe Biden at the State of the Union address with Vice President Kamala Harris and House Speaker Kevin McCarthy (Patrick Semansky/AP Images)

The drug pric­ing pres­i­dent: Biden warns of ve­to for any IRA re­peal at­tempts

Pres­i­dent Joe Biden made clear in his “fin­ish the job” State of the Union ad­dress last night that one of those jobs to be fin­ished is in­sulin prices.

Biden’s push again to tack­le in­sulin prices, af­ter Re­pub­li­cans re­buffed the idea last sum­mer and just af­ter Biden won Medicare drug price ne­go­ti­a­tions/caps via the In­fla­tion Re­duc­tion Act, shows how heav­i­ly he’s lean­ing in­to this work.

“You know, we pay more for pre­scrip­tion drugs than any ma­jor coun­try on Earth,” he said last night, pledg­ing ac­tion.

We capped the cost of in­sulin at $35 a month for se­niors on Medicare. But there are mil­lions of oth­er Amer­i­cans who are not on Medicare, in­clud­ing 200,000 young peo­ple with Type I di­a­betes who need in­sulin to save their lives. Let’s fin­ish the job this time.  Let’s cap the cost of in­sulin at $35 a month for every Amer­i­can who needs it.

The call to cap out-of-pock­et costs for in­sulin at $35 per month is not new, and even some of the biggest in­sulin mak­ers like Eli Lil­ly and Sanofi are back­ing the mea­sure.

In June, Sanofi al­so cut the month­ly price of its in­sulins for unin­sured Amer­i­cans to $35, down from $99 pre­vi­ous­ly.

Biden al­so played up the IRA’s oth­er new cap — on out-of-pock­et drug costs for se­niors on Medicare, which is now set at a max­i­mum of $2,000 per year. He al­so touched on how if drug prices now rise faster than in­fla­tion, “drug com­pa­nies will have to pay Medicare back the dif­fer­ence. And we’re fi­nal­ly giv­ing Medicare the pow­er to ne­go­ti­ate drug prices. Bring­ing down pre­scrip­tion drug costs doesn’t just save se­niors mon­ey.”

De­tails on both the re­bates and ne­go­ti­a­tions still need to be ironed out at CMS in the com­ing months, but Biden not­ed that some mem­bers (it passed on a strict­ly par­ti­san vote) are threat­en­ing to re­peal the IRA, to which Biden promised a swift ve­to.

“Make no mis­take, if you try to do any­thing to raise the cost of pre­scrip­tion drugs, I will ve­to it,” he said.

Over­all, the speech con­tin­ued his pub­lic push against phar­ma.

From mid-Au­gust through ear­ly No­vem­ber, Biden was not ex­act­ly shy about how hap­py he was to have de­feat­ed Big Phar­ma with the pas­sage of the IRA and the sub­se­quent Medicare drug price ne­go­ti­a­tions that will kick off in 2026.

Biden’s ral­ly­ing cry around beat­ing Big Phar­ma has been the high­light of stump speech­es.

“We beat Phar­ma this year,” Biden said at a La­bor Day cel­e­bra­tion in Mil­wau­kee on Sept. 5. “We beat Phar­ma this year, and it mat­tered. We’re go­ing to change peo­ple’s lives. (Ap­plause.) We fi­nal­ly beat Phar­ma.”

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Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

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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Man­u­fac­tur­ing roundup: Catal­ent to pro­duce low-cost ver­sion of nalox­one; CSL opens R&D site

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.

As­pen looks to re­bound in pro­duc­tion and rev­enue af­ter Covid-19

Last year, South African-based vaccine manufacturer Aspen Pharmacare was facing reports that it had not received a single order for its manufactured Covid-19 shots and that manufacturing lines were sitting idle. But now the vaccine producer is looking to turn things around.

Aspen’s disclosure of its financial results in March unveiled that manufacturing revenue had decreased by 12% to R 603 million ($33.8 million), which Lorraine Hill, Aspen Group’s COO, said is attributable to lower Covid vaccine sales.

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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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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Ribbon cutting ceremony for Thermo Fisher's new cell therapy manufacturing site in San Francisco

Ther­mo Fish­er moves on cam­pus with new cell man­u­fac­tur­ing site in San Fran­cis­co

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

Sulagna Bhattacharya, Nanoscope Therapeutics CEO

Nanoscope’s eye dis­ease gene ther­a­py shows mixed re­sults in PhII

Dallas-based biotech Nanoscope Therapeutics unveiled Phase II results on its gene therapy for a rare eye disease Thursday morning.

In the RESTORE trial, 18 patients with retinitis pigmentosa got a gene therapy called MCO-010 while nine got placebo. On a vision test called the MLYMT, the treatment group had a one-point greater change over one year in their score compared to the placebo group, the primary endpoint of the study. However, the 95% confidence interval was 0.0 to 3.0, meaning the result was not statistically significant. The p-value was not provided.