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Arikayce could become Insmed’s second blockbuster Read in browser
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23 March, 2026
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top stories
1. Novartis to invest $480M in China following AstraZeneca and Lilly pledges
2. FDA posts photos of Indian drugmaking facility cited in warning letter
3. Arikayce could become Insmed’s second blockbuster following late-stage win in lung infection
4. Lack of cases hampers Pfizer’s Phase 3 Lyme disease vaccine trial
5. Apogee’s Phase 2 data show its eczema drug could have the convenience edge over Dupixent, Ebglyss
6. WuXi AppTec’s bet on the US pays off as revenues dip elsewhere
7. Aurinia's CEO and C-suite are out as investor Kevin Tang consolidates control
more stories
 
Alexis Kramer
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The US government will get to say its piece when the Supreme Court hears arguments in a closely-watched ‘skinny label’ case. The high court on Monday granted the US solicitor general’s request to participate in the April 29 oral argument. The case is between Hikma and Amarin, but DOJ attorneys fear that a decision in Amarin’s favor could undermine a pathway commonly used to bring generic drugs to market.

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Alexis Kramer
Editor, Endpoints News
1
by Anna Brown

No­var­tis is the lat­est drug­mak­er to in­vest in its Chi­nese foot­print, with a pledge of more than 3.3 bil­lion yuan ($480 mil­lion) to bol­ster two man­u­fac­tur­ing and R&D sites.

The com­pa­ny will pour 1.5 bil­lion yuan ($218 mil­lion) in­to ex­pand­ing its tablets and cap­sules site in the Chang­ping dis­trict of Bei­jing, ac­cord­ing to a Sun­day re­lease in Chi­nese. Around 1.8 bil­lion yuan ($262 mil­lion) will go to launch­ing the "sec­ond phase" of the drug­mak­er’s Chi­na head­quar­ters and R&D fa­cil­i­ty in Shang­hai. It was­n't clear what that phase en­tailed, and No­var­tis did­n't im­me­di­ate­ly com­ment be­fore pub­li­ca­tion.

No­var­tis joins the ranks of As­traZeneca and Eli Lil­ly, which have al­so made re­cent in­vest­ments in Chi­na. The pledges come at a time when West­ern drug­mak­ers are look­ing to tap in­to Chi­na's ear­ly-stage re­search.

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2
by Zachary Brennan

In a rare move, the FDA last week post­ed pho­tographs of di­lap­i­dat­ed build­ings as part of a warn­ing let­ter for a Daman, In­dia-based drug man­u­fac­tur­ing fa­cil­i­ty.

The pho­tographs are the lat­est sign that FDA Com­mis­sion­er Mar­ty Makary is tak­ing a tougher stance on for­eign drug man­u­fac­tur­ers.

Fol­low­ing a five-day unan­nounced in­spec­tion last Ju­ly, the FDA warn­ing let­ter is­sued to Pat­cos Cos­met­ics de­scribes "in­san­i­tary con­di­tions," par­tic­u­lar­ly in the sinks in the pro­duc­tion area that Pat­cos used "as a source of wa­ter for clean­ing pro­duc­tion equip­ment." The com­pa­ny's web­site says that it man­u­fac­tures oral care and aerosols on a con­tract ba­sis.

The agency pub­lished the fol­low­ing pho­to of the sinks as part of the let­ter:

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Drug Discovery Day 2026
AI has gone from buzzword to pipeline strategy — but are the results a mixed bag? We're talking to the researchers in the thick of it about what's moving the needle, what's stalling out and what comes next. Join us for a free virtual program, then continue the conversation at an in-person-only fireside and happy hour in Boston. Choose your pass.
3
by Elizabeth Cairns

In­s­med's Phase 3 tri­al win for Arikayce in a par­tic­u­lar kind of lung in­fec­tion sets up the drug to ex­pand in­to the front-line set­ting — pos­si­bly giv­ing the biotech a sec­ond pro­ject­ed block­buster.

The com­pa­ny said that Arikayce was bet­ter than place­bo at both im­prov­ing symp­toms and re­duc­ing bac­te­r­i­al lev­els when giv­en on top of es­tab­lished an­tibac­te­ri­als in pa­tients with a new case of My­cobac­teri­um avi­um com­plex (MAC) lung in­fec­tion who had not re­ceived pri­or an­tibi­otics.

In­smed need­ed a hit in the study: its shares IN­SM are down more than 20% across 2026 so far.

Sub­jects in the Phase 3b EN­CORE tri­al who re­ceived In­smed’s drug for a year had a 17.8-point im­prove­ment on a score de­signed to mea­sure res­pi­ra­to­ry symp­toms, which was ad­min­is­tered a month af­ter treat­ment end­ed. Those in the place­bo group im­proved by 14.7 points, a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence.

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4
by Max Bayer

Pfiz­er's fi­nal-stage tri­al of its long-await­ed Ly­me dis­ease vac­cine missed its pri­ma­ry end­point, but the drug­mak­er said it still plans to try to take the ex­per­i­men­tal shot to reg­u­la­tors for ap­proval.

The com­pa­ny said there had been too few Ly­me cas­es to get a firm re­sult in the tri­al of the vac­cine, known as LB6V.

That re­sult­ed in a con­fi­dence in­ter­val on one of the pre-spec­i­fied analy­sis for which the low­est end was be­low 20%, miss­ing the Phase 3 study’s pri­ma­ry end­point. Con­fi­dence in­ter­vals with wide ranges sug­gest too lit­tle da­ta for analy­sis, and Pfiz­er cit­ed “few­er than an­tic­i­pat­ed Ly­me dis­ease cas­es” in its an­nounce­ment of the re­sults.

A spokesper­son for Pfiz­er did not say how many cas­es were ac­crued in each arm of the tri­al, say­ing more da­ta will be re­leased lat­er.

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5
by Ayisha Sharma

Apogee Ther­a­peu­tics said its mod­er­ate-to-se­vere eczema can­di­date could of­fer much more con­ve­nient dos­ing over stan­dard treat­ments based on its lat­est mid-stage re­sults.

Mon­day’s Phase 2 main­te­nance