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UK gives drugmakers third extension to opt out of medicine rebate scheme Read in browser
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1. Law to end government shutdown also seeks to accelerate prescription-to-OTC drug switches
2. Pfizer closes up to $10B deal for obesity biotech Metsera
3. UK gives drugmakers third extension to opt out of medicine rebate scheme
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Alexis Kramer
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Novartis and three other drugmakers will be in court on Monday to fight for their proposed 340B rebate models. The oral argument was scheduled before HHS approved applications from eight drugmakers to participate in a 340B rebate model pilot program (Novartis’ plan has not yet been approved). Stay tuned to see how the pilot program might impact the lawsuits.

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Alexis Kramer
Editor, Endpoints News
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by Zachary Brennan

Pres­i­dent Don­ald Trump on Wednes­day evening signed in­to law a short-term gov­ern­ment fund­ing deal to end the longest shut­down in gov­ern­ment his­to­ry, which al­so in­cludes sev­er­al pro­vi­sions for the FDA.

The new law sets up an­oth­er round of user-fee fund­ing for over-the-counter drugs at the FDA through Oc­to­ber 2030, and it al­so calls on the FDA to im­prove the process for com­pa­nies look­ing to switch a pre­scrip­tion drug to a non­pre­scrip­tion, or OTC, drug.

The broad­er fund­ing agree­ment in the law, how­ev­er, on­ly lasts un­til Jan. 30, set­ting up the pos­si­bil­i­ty of an­oth­er show­down that could again dis­rupt many gov­ern­ment op­er­a­tions.

Un­der the new OTC pro­vi­sion, com­pa­nies seek­ing an OTC switch can sub­mit a writ­ten re­quest for a meet­ing with the FDA to talk through how to ad­dress po­ten­tial risks, and what ev­i­dence and stud­ies might be need­ed.

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Pfizer CEO Albert Bourla (Stefan Wermuth/Bloomberg via Getty Images)
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by Alexis Kramer

Pfiz­er said Thurs­day it has com­plet­ed its up to $10 bil­lion ac­qui­si­tion of obe­si­ty biotech Met­sera.

It sig­nals the of­fi­cial end to a high-stakes, heat­ed bid­ding war be­tween Pfiz­er and No­vo Nordisk that got both the courts and the Fed­er­al Trade Com­mis­sion in­volved. Met­sera ul­ti­mate­ly ac­cept­ed Pfiz­er’s of­fer late last Fri­day, af­ter the FTC warned the biotech that No­vo’s bid was risky un­der US an­titrust law.

The deal gives Pfiz­er a fresh op­por­tu­ni­ty in the obe­si­ty space af­ter its pre­vi­ous at­tempts to en­ter the mar­ket end­ed in fail­ure.

“By ac­quir­ing Met­sera, we are di­rect­ing our re­sources to­ward one of the most im­pact­ful and high-growth ther­a­peu­tic ar­eas and po­si­tion­ing our­selves to de­fine it,” Pfiz­er CEO Al­bert Bourla said in a Thurs­day state­ment.

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by Alexis Kramer

The UK has again ex­tend­ed the dead­line for phar­ma com­pa­nies to de­cide whether to ex­it the coun­try’s drug re­bate scheme.

The UK gov­ern­ment and the As­so­ci­a­tion of the British Phar­ma­ceu­ti­cal In­dus­try agreed to a new dead­line of Dec. 16 for drug­mak­ers to leave the UK’s Vol­un­tary Scheme for Brand­ed Med­i­cines Pric­ing and Ac­cess, the trade group said in a Thurs­day state­ment. The pre­vi­ous dead­line was Nov. 14, af­ter get­ting pushed back twice al­ready.

VPAG is the per­cent­age of sales a com­pa­ny pays back to the UK’s Na­tion­al Health Ser­vice. Drug­mak­ers have been lob­by­ing for the gov­ern­ment to low­er its VPAG rate, but the near­ly 23% rate re­mains un­changed af­ter drug pric­ing deal talks col­lapsed in Au­gust. Since then, phar­ma com­pa­nies have been re­think­ing in­vest­ments in the UK over con­cerns that the gov­ern­ment isn’t do­ing enough to pro­mote the sec­tor.

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