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top stories
1. FDA quietly stops releasing CRLs
2. Catalent to divest UK site; Rottendorf, Evonik announce manufacturing builds
3. FDA approvals outrun staff cuts: 23 novel drugs mark the best first half in three years
4. Novartis, Vertex and Ipsen extend pharma's M&A spree after 45 first-half acquisitions
5. Sandoz tests direct-to-consumer sales with Omnitrope, a growth hormone biosimilar
Anna Brown
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We’re closely following WuXi AppTec’s case against the US government over its addition to the Pentagon's 1260H list. The Department of Defense has until Monday to respond to WuXi’s preliminary injunction. Reach out for any tips or leads.

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Anna Brown
Biopharma Breaking News Reporter, Endpoints News
1
by Zachary Brennan

The FDA has paused its pub­lic re­lease of phar­ma re­jec­tion let­ters as the agency seeks to avoid lit­i­ga­tion around re­leas­ing the of­ten sen­si­tive in­for­ma­tion.

The...

Read the full story
2
by Anna Brown

Plus, news about RoslinCT, No­vo Nordisk and more.  

🇬🇧 Catal­ent to sell UK site to Codis: The CD­MO is set to takeCatal­ent’s oral sol­id...

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3
by Zachary Brennan

There's an an­swer emerg­ing on the multi­bil­lion-dol­lar ques­tion of whether the Trump ad­min­is­tra­tion's gut­ting of FDA staff in April 2025 would slow down drug ap­provals...

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Image: Shutterstock
4
by Kyle LaHucik

Bio­phar­ma's M&A en­gine is revved up and shows no signs of cool­ing off.

Four com­pa­nies have an­nounced ac­qui­si­tions in the first six days of Ju­ly...

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5
by Nicole DeFeudis

San­doz un­veiled a di­rect-to-con­sumer plat­form, start­ing off with a sin­gle med­ica­tion for now as the gener­ic drug­mak­er adopts a sys­tem that sev­er­al brand-name man­u­fac­tur­ers are...

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