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FDA asks Novavax for post-marketing data of its Covid vaccine, delaying approval Read in browser
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1. Large vaccine makers stand by their investments despite US headwinds
2. Top pharma companies increased lobbying spend in first quarter of 2025
3. FDA asks Novavax for post-marketing data of its Covid vaccine, delaying approval
4. AstraZeneca CEO says Europe is 'falling behind' on R&D and manufacturing investments
5. Eli Lilly sues four telehealth companies selling compounded tirzepatide
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Alexis Kramer
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Novavax finally heard back from the FDA on its Covid-19 vaccine. The review deadline came and went several weeks ago, and now Novavax says the agency has asked it to commit to producing post-marketing data. Max Bayer has the details.

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Alexis Kramer
Editor, Endpoints News
1
by Max Bayer

WASH­ING­TON — Rep­re­sen­ta­tives from large vac­cine mak­ers say they are com­mit­ted to their pipelines, de­spite a new wave of scruti­ny in the US that risks di­min­ish­ing a ma­jor mar­ket.

On a pan­el at the World Vac­cine Con­gress this week, ex­ec­u­tives from Mer­ck, Mod­er­na, Pfiz­er, Sanofi and GSK stood by their clin­i­cal-stage ef­forts and said they'll con­tin­ue to in­vest in vac­cines.

“We’re in this for the long game,” Sal­ly Moss­man, Sanofi's VP and head of re­search port­fo­lio strat­e­gy, said Tues­day. “We be­lieve in vac­cines, and the val­ue of vac­cines and what they bring to pub­lic health."

Ale­jan­dra Gurt­man, Pfiz­er’s se­nior vice pres­i­dent of vac­cines clin­i­cal re­search and de­vel­op­ment, said “we will al­ways stand be­hind the sci­ence and what has tak­en us here.”

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2
by Zachary Brennan

Pfiz­er, No­var­tis, Am­gen, Eli Lil­ly and John­son & John­son were the top con­gres­sion­al lob­by­ing spenders among the ma­jor bio­phar­ma com­pa­nies, as the in­dus­try faces a tu­mul­tuous en­vi­ron­ment in which the Trump ad­min­is­tra­tion has made huge changes to trade, reg­u­la­to­ry and sci­ence pol­i­cy.

Phar­ma tar­iffs, PBM re­forms, the In­fla­tion Re­duc­tion Act, restor­ing the or­phan drug tax cred­it and on­shoring phar­ma­ceu­ti­cals were all cit­ed as is­sues by phar­ma com­pa­nies in the lat­est round of quar­ter­ly lob­by­ing dis­clo­sures by Con­gress.

In­di­anapo­lis-based Lil­ly, for ex­am­ple, spent $3.4 mil­lion on lob­by­ing in the first quar­ter of this year — rough­ly dou­ble its spend­ing from the first quar­ter of 2024. The com­pa­ny said its lob­by­ing was fo­cused on tar­iffs, IP pro­tec­tion, and trade-re­lat­ed talks with Chi­na, the EU, In­dia and oth­ers.

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3
by Max Bayer

The FDA has asked No­vavax to com­mit to pro­duc­ing post-mar­ket­ing da­ta of its Covid vac­cine, the clear­est ex­am­ple yet that the goal­posts have changed for vac­cine mak­ers un­der HHS Sec­re­tary Robert F. Kennedy Jr.’s lead­er­ship.

The com­pa­ny said in a Wednes­day state­ment that it “re­cent­ly re­ceived for­mal com­mu­ni­ca­tion from the FDA in the form of an in­for­ma­tion re­quest for a post mar­ket­ing com­mit­ment (PMC) to gen­er­ate ad­di­tion­al clin­i­cal da­ta.”

“We look for­ward to en­gag­ing with the FDA ex­pe­di­tious­ly to ad­dress the PMC re­quest and move to ap­proval as soon as pos­si­ble,” the com­pa­ny said.

HHS spokesper­son An­drew Nixon said in a state­ment that "HHS re­mains com­mit­ted to our promise: en­sur­ing prod­ucts are safe for the Amer­i­can peo­ple and ground­ed in gold-stan­dard sci­ence."

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AstraZeneca CEO Pascal Soriot in London in 2023 (Justin Tallis/Press Association via AP Images)
4
by Nicole DeFeudis

As­traZeneca CEO Pas­cal So­ri­ot called on Eu­rope to step up in­vest­ments and “pro­tect its health sov­er­eign­ty" as it falls be­hind the US on spend­ing.

His com­ments echo calls from oth­er phar­ma CEOs who are say­ing that Eu­rope needs to bet­ter in­cen­tivize in­no­va­tion. Mul­ti­ple drug com­pa­nies have made re­cent multi­bil­lion-dol­lar com­mit­ments to boost their ca­pa­bil­i­ties in the US.

“The world or­der is shift­ing right now and Eu­rope needs to in­vest more in what re­al­ly mat­ters to it," So­ri­ot said in a state­ment sent to End­points News on Wednes­day. “Eu­rope spends a sub­stan­tial­ly low­er share of GDP on in­no­v­a­tive med­i­cines than the US and, as a re­sult, is falling be­hind in at­tract­ing R&D and man­u­fac­tur­ing in­vest­ments, putting its abil­i­ty to pro­tect the health of its own peo­ple at risk."

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5
by Shelby Livingston

Just a few weeks af­ter Eli Lil­ly sued two large com­pound­ing phar­ma­cies, the phar­ma gi­ant on Wednes­day filed law­suits against four tele­health com­pa­nies over their sale of com­pound­ed ver­sions of the GLP-1 obe­si­ty drug tirzepatide.

In four sep­a­rate com­plaints, Lil­ly al­leged that the tele­health com­pa­nies de­ceive cus­tomers and make false claims about their com­pound­ed tirzepatide drugs, in­clud­ing that the med­ica­tions are safe and ef­fec­tive and per­son&