New in­fla­tion-linked drug re­bates go in­to ef­fect on Sat­ur­day

Be­gin­ning to­mor­row, bio­phar­ma com­pa­nies can be charged re­bates for any new drug price in­creas­es ris­ing faster than the rate of in­fla­tion.

The new re­bates are part of the new­ly signed In­fla­tion Re­duc­tion Act, which in­tro­duces this new re­quire­ment that man­u­fac­tur­ers pay re­bates to Medicare for Part D drugs whose price in­creas­es ex­ceed in­fla­tion, and in Jan­u­ary 2023, the same will oc­cur with Part B drugs.

The re­bate sys­tem “was de­signed to re­duce the fre­quen­cy and size of drug price in­creas­es,” HHS says. The IRA al­so in­cludes a pro­vi­sion that al­lows CMS to ne­go­ti­ate and/or cap the prices of 10 of the most ex­pen­sive drugs.

While those ne­go­ti­a­tions will be lim­it­ed, the re­bates paid by the in­dus­try may be sig­nif­i­cant. HHS re­leased a new re­port on Fri­day out­lin­ing what the IRA could do as more than 1,200 drug price in­creas­es from Ju­ly 2021 to Ju­ly 2022 ex­ceed­ed the in­fla­tion rate of 8.5% for that time pe­ri­od. The re­port notes:

Most price in­creas­es oc­cur at the be­gin­ning of Jan­u­ary, with more than 3000 drugs ex­pe­ri­enc­ing a price in­crease in 2022, up from 2650 in 2016. The num­ber of Ju­ly price in­creas­es trend­ed down­ward from 613 ND­Cs in 2016 to 203 in 2021, but in Ju­ly of 2022, the num­ber of in­creas­es rose to a lev­el sim­i­lar to that ob­served in 2016, with 601 in­creas­es.

HHS on Fri­day al­so re­leased an­oth­er re­port that “found a steady in­crease in pre­scrip­tion drug spend­ing from $520 bil­lion in 2016 to $603 bil­lion in 2021. This in­crease was dri­ven by in­creas­es in spend­ing per pre­scrip­tion, and less so by in­creas­es in the num­ber of pre­scrip­tions.”

And while the in­fla­tion-linked re­bates will hit all phar­ma com­pa­nies, HHS notes that drug spend­ing “is heav­i­ly dri­ven by a rel­a­tive­ly small num­ber of high-cost prod­ucts. The cost of spe­cial­ty drugs has con­tin­ued to grow, to­tal­ing $301 bil­lion in 2021, an in­crease of 43% since 2016.”

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

Pro­tect­ing its megablock­buster, Janssen chal­lenges Am­gen's Ste­lara biosim­i­lar ahead of planned 2023 launch

Johnson & Johnson unit Janssen on Wednesday sued Amgen over the company’s proposed biosimilar to its megablockbuster Stelara (ustekinumab), after Amgen said it was ready to launch next May or as soon as the FDA signs off on it.

If Amgen carries through with that plan, Janssen told the Delaware district court that the Thousand Oaks, CA-based company will infringe on at least two Janssen patents.

Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.