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17 December, 2025
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1. Several companies expected to announce ‘most favored nation’ deals Friday at White House, sources say
2. Weakened Biosecure Act poised to become law after Senate passage
3. RFK Jr. adds conditions to newborn screening list, but future path unclear
4. GSK formally submits new leucovorin indication to FDA for developmental disorder
5. CDC drops longtime hepatitis B vaccination advice for newborns
6. European Commission unveils EU Biotech Act as it lags behind other countries 
7. Novo Nordisk hit with FDA warning letter over acquired Catalent factory
8. Hansa’s enzyme therapy flunks Phase 3 trial in rare kidney disease
9. Padcev-Keytruda combination notches another bladder cancer win
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Alexis Kramer
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GSK told us today that it has formally applied to update its label for leucovorin, per the FDA’s request. The agency asked GSK in September to add a new indication for cerebral folate deficiency, a developmental disorder that’s been linked to autism. But it still isn’t clear what data the FDA was relying on. The request has also raised several other questions, including who will supply the drug.

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Alexis Kramer
Editor, Endpoints News
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by Drew Armstrong, Max Bayer

The White House is prepar­ing to un­veil sev­er­al new deals with large drug­mak­ers on Fri­day as part of the ad­min­is­tra­tion’s “most fa­vored na­tion” pric­ing push, ac­cord­ing to sources fa­mil­iar with the plans.

The an­nounce­ment is like­ly to mim­ic oth­er re­cent most fa­vored na­tion un­veil­ings, with com­pa­ny CEOs and Pres­i­dent Don­ald Trump in the Oval Of­fice, said the sources, all of whom spoke on con­di­tion of anonymi­ty be­cause the an­nounce­ment isn’t yet pub­lic.

The ad­min­is­tra­tion has been work­ing to fi­nal­ize the deals, un­der which drug­mak­ers have agreed to cash-pay prices for some drugs, and to give the gov­ern­ment dis­counts on oth­ers in Medicare or Med­ic­aid. So far, Pfiz­er, As­traZeneca, Eli Lil­ly, No­vo Nordisk and EMD Serono have made deals.

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by Jared Whitlock

The Biose­cure Act is slat­ed to be­come law af­ter the Sen­ate on Wednes­day passed a de­fense bill that in­cludes the mea­sure.

It's a de­vel­op­ment that once would have sent pan­ic through drug­mak­er board­rooms. But the leg­is­la­tion has since been weak­ened. Biose­cure would re­strict fed­er­al con­tracts with bio­phar­ma sup­pli­ers deemed for­eign ad­ver­saries, though un­like ear­li­er drafts, it stops short of nam­ing the ubiq­ui­tous con­trac­tors WuXi AppTec and WuXi Bi­o­log­ics.

Sens. Bill Hager­ty (R-TN) and Gary Pe­ters (D-MI) re­vived the leg­is­la­tion this sum­mer fol­low­ing in­flu­en­tial op­po­si­tion.

Last year, Rep. Jim Mc­Gov­ern (D-MA) and Sen. Rand Paul (R-KY) killed Biose­cure by ar­gu­ing it lacks due process for the WuXi en­ti­ties. That led to a com­pro­mise ver­sion that no longer names spe­cif­ic com­pa­nies. In­stead, the lat­est it­er­a­tion im­pos­es re­stric­tions on com­pa­nies that are on fed­er­al watch­lists. The Sen­ate vot­ed in Oc­to­ber to at­tach this new ver­sion to the an­nu­al de­fense pol­i­cy bill.

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A nurse puts a blood sample from a newborn onto a file card for a rare disease screening (Arno Burgi/picture-alliance/dpa/AP Images)
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by Jared Whitlock

HHS Sec­re­tary Robert F. Kennedy Jr. added two con­di­tions to a fed­er­al new­born screen­ing list, re­viv­ing ef­forts that had been stalled un­der the Trump ad­min­is­tra­tion — though the process for adding more dis­eases is still un­cer­tain.

Dur­ing an HHS event on Tues­day, Kennedy said metachro­mat­ic leukody­s­tro­phy (MLD) and Duchenne mus­cu­lar dy­s­tro­phy will be placed on the fed­er­al gov­ern­ment’s Rec­om­mend­ed Uni­form Screen­ing Pan­el. Drug­mak­ers and pa­tient ad­vo­cates wel­comed the de­ci­sion, af­ter warn­ing that de­lays could im­per­il ac­cess to crit­i­cal ther­a­pies.

In April, an ex­ec­u­tive or­der signed by Pres­i­dent Don­ald Trump to elim­i­nate “un­nec­es­sary” fed­er­al func­tions shut down the Ad­vi­so­ry Com­mit­tee on Her­i­ta­ble Dis­or­ders in New­borns and Chil­dren. The com­mit­tee rec­om­mends dis­eases to screen for at birth, though states typ­i­cal­ly adopt the rec­om­men­da­tions whole­sale over time.

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Emma Walmsley, GSK CEO (courtesy Financial Times)
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by Max Bayer