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.

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.

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:

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 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.

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.