Mike Bloomberg (AP IMAGES)

Mike Bloomberg joins a grow­ing cho­rus of De­mo­c­ra­t­ic pres­i­den­tial can­di­dates threat­en­ing to go af­ter drug patents

As the may­or of New York City, Mike Bloomberg had a few mod­est ideas about low­er­ing pre­scrip­tion drug prices in the Big Ap­ple that gained lit­tle trac­tion. Now on the cam­paign trail on a faint hope of clinch­ing the De­mo­c­ra­t­ic pres­i­den­tial nom­i­na­tion, the bil­lion­aire has some big­ger plans — in­clud­ing one that would al­ter the patent sys­tem cen­tral to the bio­phar­ma busi­ness.

In a bare­bones drug pric­ing plan post­ed on Mon­day, Bloomberg came out blast­ing Pres­i­dent Don­ald Trump for fail­ing to de­liv­er his promise to low­er drug prices, and then mak­ing mis­lead­ing claims about them. The price of over 3,000 drugs still in­creased at a rate five times high­er than in­fla­tion in the first six months of 2019, he wrote.

So how will he fix it? Bloomberg lists a few wide­ly dis­cussed pol­i­cy pro­pos­als, in­clud­ing au­tho­riz­ing Medicare to ne­go­ti­ate drug prices (a key goal of Nan­cy Pelosi’s re­cent­ly passed House bill), al­low­ing Amer­i­cans to buy med­i­cine from oth­er coun­tries (some­thing the HHS has re­leased a plan on), and cap­ping out-of-pock­et costs for Medicare ben­e­fi­cia­ries.

He al­so pledged to elim­i­nate “pay­offs” — pre­sum­ably the arrange­ment com­mon­ly known as re­bates — from drug­mak­ers to phar­ma­cy ben­e­fit man­agers. The White House had set out to do the same but changed course to kill re­bate re­form back in Ju­ly.

But Bloomberg’s most eye-catch­ing pro­pos­al is this: “Bring gener­ic drugs to the mar­ket faster by lim­it­ing brand-name drug mak­ers to one patent that lasts 20 years.”

Ac­cel­er­at­ing the speed of gener­ics ap­proval had been a key goal for for­mer FDA Com­mis­sion­er Scott Got­tlieb, who called out brand­ed drug­mak­ers for “shenani­gans” to de­lay gener­ic drug com­pe­ti­tion. Dur­ing his tenure, Got­tlieb al­so im­ple­ment­ed new poli­cies aimed at bar­ring phar­ma from ex­ploit­ing REMS re­quire­ments for their ben­e­fit.

But chang­ing patent and IP laws could be a dras­tic ex­pan­sion of that ef­fort. Ab­b­Vie has re­port­ed­ly se­cured more than 100 patents to pro­tect Hu­mi­ra, the best-sell­ing drug on the plan­et and a multi­bil­lion-dol­lar fran­chise.

While the 20-year term is in line with cur­rent lim­its, Bloomberg al­so didn’t spec­i­fy if his so­lu­tion would al­low for patent ex­ten­sions (max­i­mum 5 years) un­der the Hatch-Wax­man Act.

The oth­er part of Bloomberg’s re­form would have drug com­pa­nies pay roy­al­ties to the NIH if they use NIH IP and turn it in­to a com­mer­cial prod­uct — which can be con­tro­ver­sial as il­lus­trat­ed in Gilead’s re­cent dis­putes with the HHS over HIV patents. Bloomberg stopped short of spelling out the con­se­quences for any phar­ma play­ers who don’t com­ply with his poli­cies. Sen­a­tors Eliz­a­beth War­ren and Bernie Sanders — who are polling ahead of Bloomberg — have both sug­gest­ed that they would seize or break drug patents over what they view as egre­gious pric­ing.

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.

Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.

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.