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Lilly resumes its fight to call retatrutide a biologic Read in browser
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13 February, 2026
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1. Pentagon does quick about-face after adding WuXi AppTec to Chinese military list
2. Lilly appeals ruling over retatrutide classification in case that could impact compounders
3. Lilly stockpiles $1.5B worth of weight loss pill ahead of US approval
4. Gilead gets cancer drug from China-based Genhouse for $80M upfront
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Paul Hudson couldn’t quite get Sanofi over the hump; PROTAC developer Arvinas appoints CEO
6. PTC Therapeutics withdraws US filing for troubled Duchenne treatment
7. Updated: Ultragenyx to lay off about 130 employees, resubmit rare disease application again
8. Lundbeck's migraine prevention drug succeeds in Phase 2, advancing new therapy class
9. Moderna is noncommittal on 2028 break-even guidance, with flu shot future in flux
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Alexis Kramer
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HHS Secretary Robert F. Kennedy Jr. is shaking up his senior leadership staff with the removal of Peter Thiel ally Jim O’Neill as both CDC acting director and deputy HHS Secretary, according to the Washington Post. RFK also promoted MFN dealmaker and Medicare chief Chris Klomp to oversee all operations of HHS. FDA deputy commissioner Grace Graham also was named senior counselor for the FDA, according to Kennedy.

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Alexis Kramer
Editor, Endpoints News
1
by Jared Whitlock

The Pen­ta­gon on Fri­day briefly added WuXi AppTec to a list of com­pa­nies that aid the Chi­nese mil­i­tary be­fore with­draw­ing the fil­ing with no ex­pla­na­tion.

If the list is re­post­ed as is, the des­ig­na­tion would height­en scruti­ny of the biotech sup­pli­er and make it a tar­get of the re­cent­ly passed Biose­cure Act that re­stricts fed­er­al con­tracts with bio­phar­ma sup­pli­ers that are deemed for­eign ad­ver­saries. Biose­cure de­fers to the Pen­tagon's 1260H list of Chi­nese mil­i­tary com­pa­nies.

The ul­ti­mate de­ci­sion may have far-reach­ing con­se­quences. The Shang­hai-based com­pa­ny start­ed out decades ago of­fer­ing on­ly lab ser­vices be­fore ex­pand­ing in­to drug dis­cov­ery, de­vel­op­ment and man­u­fac­tur­ing. WuXi con­trols a large share of the con­tract re­search mar­ket and has said it works with the 20 largest phar­ma­ceu­ti­cals.

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2
by Alexis Kramer

Eli Lil­ly is chal­leng­ing a de­ci­sion over how the FDA clas­si­fied its ex­per­i­men­tal, next-gen obe­si­ty shot, in a case that could af­fect the abil­i­ty of com­pounders to ri­val it.

On Thurs­day, Lil­ly filed a no­tice to ap­peal a Sep­tem­ber dis­trict court de­ci­sion that said the FDA didn’t vi­o­late the law when it de­cid­ed to clas­si­fy re­ta­tru­tide as a drug in­stead of a bi­o­log­ic. Lil­ly is bring­ing the case to the US Court of Ap­peals for the Sev­enth Cir­cuit.

How a prod­uct is clas­si­fied de­ter­mines what mar­ket­ing rules it’s sub­ject to, the po­ten­tial length of ex­clu­siv­i­ty and whether the prod­uct can legal­ly be com­pound­ed. An ap­peals court rul­ing could have a sig­nif­i­cant im­pact on the ex­tent to which Lil­ly might face cheap­er, com­pound­ed com­peti­tors once re­ta­tru­tide hits the mar­ket. Bi­o­log­i­cal prod­ucts are not el­i­gi­ble for com­pound­ing, ac­cord­ing to the FDA.

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3
by Anna Brown

Eli Lil­ly is con­tin­u­ing to stock­pile its obe­si­ty pill or­for­glipron months ahead of its ex­pect­ed US launch.

In a Thurs­day SEC fil­ing, the drug­mak­er said it has $1.5 bil­lion in “pre-launch in­ven­to­ries” as of Dec. 31, “pri­mar­i­ly re­lat­ed” to or­for­glipron.

Last Feb­ru­ary, Lil­ly said it had al­ready stock­piled $548 mil­lion worth of the oral GLP-1 can­di­date, ready to be dis­trib­uted as soon as the drug gains reg­u­la­to­ry ap­proval. Or­for­glipron is ex­pect­ed to be ap­proved by the FDA in April.

The In­di­anapo­lis-based com­pa­ny is ready­ing its sup­ply while ri­val No­vo Nordisk has an ear­ly lead in the oral GLP-1 space. No­vo launched its We­govy pill last month, with pre­scrip­tion rates quick­ly ramp­ing up. No­vo said this week that it plans to ex­pand a fac­to­ry in Ire­land to make its drug.

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4
by Kyle LaHucik

Gilead is buy­ing the glob­al rights to an oral can­cer drug from Gen­house Bio, a Chi­na-based biotech that filed for an IPO on the Hong Kong Stock Ex­change last month.

The Cal­i­for­nia drug­mak­er is dish­ing out $80 mil­lion up­front for GH31, a MAT2A-tar­get­ed syn­thet­ic lethal­i­ty drug for se­lect sol­id tu­mors. MAT2A plays a role in meta­bol­ic reg­u­la­tion and can be over­ex­pressed in can­cer cells.

Gen­house could get up to $1.45 bil­lion in biobucks, the com­pa­ny an­nounced Fri­day on WeChat. A Gilead spokesper­son con­firmed the deal terms to End­points News.

The deal gives Gilead ac­cess to an­oth­er oral can­cer treat­ment, af­ter it inked pacts with Kymera and Re­pare in re­cent months. Much of the biotech's on­col­o­gy fo­cus in re­cent years, though, has been in cell ther­a­py, an­ti­body-drug con­ju­gates and oth­er an­ti­body-based med­i­cines.