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Recon: Pfizer, BioNTech submit BLA for COVID vaccine; MHRA approves first drug under Project Orbis

The Pharma Data

Catalent snaps up Promethera’s cell therapy subsidiary, complete with a Belgian plant to help scale plasmid DNA efforts ( Endpoints ). Goldman Sachs jumps aboard Bain-backed 503(b) compounding pharmacy with a $275M debt loan to supply hospitals ( Endpoints ). . Pharma & Biotech.

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TOP 5 WAYS INTEGRATED DRUG DEVELOPMENT SOLUTIONS SAVE YOU TIME AND MONEY

Alta Sciences

and Canadian CPUs with compounding pharmacies, that are integrated with our bioanalytical labs and manufacturing and analytical campus. Altasciences has U.S. In fact, one of our bioanalytical laboratories is located within a few minutes' drive of our Montréal CPU, contributing to speedy data acquisition.

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Article FDA Thank You In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties

Agency IQ

Requirements for 503A pharmacies have since been updated, most notably under the Drug Quality and Security Act ( DQSA ) of 2013, which established new requirements for 503A pharmacies as well as a new category of compounding pharmacies, known as outsourcing facilities (503B pharmacies). suppositories).

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Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

We have tried to sort guidance documents by topic area.

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