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1. Did Pfizer get a good deal with Trump? Wall Street thinks so
2. Trump’s threatened pharma tariffs won’t start Wednesday despite prior warning, White House says
3. CMS spells out new orphan drug protections in IRA negotiation guidance
4. Biogen owes Genentech $88M in 'tail' royalties from Tysabri, court rules
5. Ansa Biotechnologies closes $54.4M Series B to boost US DNA manufacturing 
6. FDA rejects treatment for rare copper deficiency over manufacturing
7. Exclusive: French startup's gene therapy dramatically reduces urinary incontinence in spinal cord injury patients
8. Halozyme to spend $750M upfront to buy Elektrofi, a biologics tech delivery company
9. Takeda stops all work in cell therapy 
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Alexis Kramer
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Earlier today, we unpacked the Trump administration’s first “most favored nation” deal with Pfizer. If you missed our Post-Hoc Live, you can watch a recording on YouTube.

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Alexis Kramer
Editor, Endpoints News
1
by Max Bayer

Of all the ob­sta­cles that the phar­ma­ceu­ti­cal in­dus­try has faced in the first year of Pres­i­dent Don­ald Trump’s sec­ond term, none have struck more fear in ex­ec­u­tives, board rooms and in­vestors than the pres­i­dent’s push to ag­gres­sive­ly cut the price of drugs in the US.

On Tues­day, Trump tout­ed Pfiz­er's wide-rang­ing deal with the gov­ern­ment as a huge win on pric­ing af­ter months of pres­sure and ne­go­ti­a­tion. At the same time, the com­pa­ny ap­pears to have suc­cess­ful­ly met the White House­'s de­mands with­out do­ing too much harm to it­self. And it could pro­vide a road map for oth­er drug­mak­ers, who for years have fought against price con­trols, to make their own deals.

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2
by Anna Brown

The Trump ad­min­is­tra­tion is start­ing to pre­pare tar­iffs on some phar­ma com­pa­nies, but those levies won’t take ef­fect on Wednes­day, a White House of­fi­cial con­firmed to End­points News.

Pres­i­dent Don­ald Trump an­nounced last Thurs­day in a so­cial me­dia post that be­gin­ning Oct. 1, drug­mak­ers that haven’t start­ed con­struc­tion projects in the US will face 100% tar­iffs on their brand­ed med­i­cines.

But the White House of­fi­cial said Wednes­day that the ad­min­is­tra­tion will on­ly “be­gin prepar­ing tar­iffs” on Oct. 1. The tar­iffs will ap­ply to com­pa­nies that aren’t on­shoring their man­u­fac­tur­ing to the US as well as those that don’t par­tic­i­pate in Trump’s most fa­vored na­tion pol­i­cy, ac­cord­ing to the of­fi­cial.

Since Trump’s post last Thurs­day, a hand­ful of drug­mak­ers have start­ed con­struc­tion on US-based projects.

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CMS Administrator Mehmet Oz (Mark Schiefelbein/AP Images)
3
by Nicole DeFeudis

CMS fi­nal­ized guid­ance this week that the agency says will in­crease trans­paren­cy in the third round of Medicare drug price ne­go­ti­a­tions and “pre­serve crit­i­cal in­cen­tives for rare dis­ease re­search.”

The guid­ance sets re­quire­ments for the first cy­cle of ne­go­ti­a­tions to po­ten­tial­ly in­clude drugs payable un­der Medicare Part B. It al­so de­scribes how CMS is ex­pand­ing pro­tec­tions for cer­tain or­phan drugs in ac­cor­dance with Pres­i­dent Don­ald Trump’s re­cent­ly en­act­ed tax and spend­ing pack­age.

Pre­vi­ous­ly, cer­tain or­phan drugs were ex­clud­ed from Medicare ne­go­ti­a­tions if they were ap­proved to treat a sin­gle rare dis­ease or con­di­tion. Now, or­phan drugs may be ex­clud­ed if they are ap­proved for more than one in­di­ca­tion, as long as it’s an­oth­er rare dis­ease or con­di­tion. If a drug is ap­proved for an in­di­ca­tion that is­n't a rare dis­ease or con­di­tion, it will no longer be ex­empt and CMS will de­ter­mine its el­i­gi­bil­i­ty for ne­go­ti­a­tions based on “the date on which the FDA ap­proves" the non-or­phan in­di­ca­tion.

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4
by Zachary Brennan

Bio­gen should pay Genen­tech more than $88 mil­lion in ad­di­tion­al roy­al­ties for us­ing Genen­tech’s patent­ed process to help make the mon­o­clon­al an­ti­body Tysabri, a Cal­i­for­nia fed­er­al jud