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This Founder Could­n't Find His Own Clin­i­cal Tri­al. Now He's En­rolling Hun­dreds of Pa­tients for Phar­ma's Biggest Names
top stories
1.
in focus
Exclusive: UC Berkeley startup bets on jumping genes for GLP-1 gene therapy
2. Is the CDC's anti-vax era coming to an end? Unpacking MAHA with Why Should I Trust You?
3.
news briefing
Avalyn plots $182M IPO; WHO prequalifies Novartis' malaria drug
4. Sanofi’s tolebrutinib gets CHMP backing for certain MS patients despite FDA rejection
5. Daiichi Sankyo postpones annual results, stock dips
6.
peer review
Pfizer’s strategy chief Andrew Baum steps down; Helus Pharma swaps out CEO after two months
7. Substance use disorder biotech Tempero to close after earlier 'serious' safety event
8. Updated: Regeneron snags hearing loss gene therapy approval, closes US pricing deal
9.
in focus
Novartis built a big business around delivering radioactive cancer treatments. Can a generic compete?
10. The Godmother of Silicon Valley is helping launch an AI healthcare residency program
more stories
 
Karen Weintraub
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Ryan Cross has a fascinating look at a new approach to treating obesity — using jumping genes as a therapy to get the body to make its own GLP-1. The approach has the potential to be permanent but reversible, and would allow repeat dosing to help keep weight off with minimal side effects. So far, it’s still being tested in animals.

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Karen Weintraub
Deputy Editor, Endpoints News
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Endpoints In Focus
1
by Ryan Cross

The new gen­er­a­tion of weight loss med­i­cines does an un­prece­dent­ed job of keep­ing off the pounds — if peo­ple stay on the drugs. Yet nu­mer­ous stud­ies sug­gest most of those who start tak­ing GLP-1 drugs quit the med­i­cines with­in a year.

One start­up has a bold so­lu­tion to the prob­lem. Ad­di­tion Ther­a­peu­tics is work­ing on a ge­net­ic med­i­cine that would turn a pa­tient’s liv­er cells in­to lit­tle fac­to­ries to per­ma­nent­ly pump out their own weight loss drugs, the start­up told End­points News in an ex­clu­sive in­ter­view.

It’s a dar­ing first ap­pli­ca­tion of the com­pa­ny’s nov­el tech­nol­o­gy, which is based on mol­e­c­u­lar ma­chines known as retro­trans­posons, al­so called jump­ing genes. Ad­di­tion is at­tempt­ing to tame these nor­mal­ly wily beasts and coax them to plop a ther­a­peu­tic code — such as the in­struc­tions for a GLP-1 drug — in­to safe spots in the genome.

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2
by Drew Armstrong

MA­HA’s sway over HHS could face a fresh test now that Pres­i­dent Trump has a new pick for CDC di­rec­tor: Er­i­ca Schwartz, a for­mer deputy sur­geon gen­er­al.

The po­si­tion has been emp­ty since Au­gust, when Su­san Monarez was oust­ed af­ter clash­es with HHS Sec­re­tary Robert F. Kennedy Jr. Like Monarez, Schwartz is a more tra­di­tion­al pub­lic health choice, with a track record of sup­port­ing vac­ci­na­tion. But a cru­cial ques­tion will be just how much in­de­pen­dence she has from Kennedy's in­flu­ence and agen­da on im­mu­niza­tion.

To­day on Post-Hoc Live at 11 a.m. ET, we’ve got a crossover episode! We'll be joined by Why Should I Trust You? host Brin­da Ad­hikari, whose show takes a look at the MA­HA move­ment and chang­ing trust in pub­lic health. Ad­hikari will be chat­ting with me and End­points’ MA­HA ex­pert Max Bay­er to talk about how Schwartz could sta­bi­lize a tur­bu­lent CDC and what the pick says about MA­HA's stand­ing in Trump­world.

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News Briefing: Quick hits from the biopharma web
3
by ENDPOINTS

Ava­lyn Phar­ma plots $182M IPO: The biotech, which is mak­ing in­haled ver­sions of ap­proved pul­monary fi­bro­sis med­i­cines, an­tic­i­pates about $182 mil­lion in net pro­ceeds if it prices its ini­tial pub­lic of­fer­ing at the mid­point of the range that it is mar­ket­ing to in­vestors. The biotech is seek­ing to sell 11.8 mil­lion shares AVLN be­tween $16 and $18 apiece. The Nas­daq float would come short­ly af­ter Kail­era Ther­a­peu­tics’ record-break­ing IPO last week. — Kyle LaHu­cik

No­var­tis wins WHO pre­qual­i­fi­ca­tion for new­born malar­ia drug: The Swiss drug­mak­er’s Coartem Ba­by will be added to the WHO's list of pre­qual­i­fied prod­ucts, which UN agen­cies and oth­er pub­lic-sec­tor pro­cur­ers use to guide fund­ing and pur­chas­ing de­ci­sions. Coartem Ba­by was ap­proved by the Swiss med­i­cines reg­u­la­tor last year. No­var­tis is pro­vid­ing the treat­ment on a large­ly not-for-prof­it ba­sis in coun­tries where malar­ia is en­dem­ic. — Ay­isha Shar­ma

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