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Gene Therapy and Pharmacokinetics

Camargo

How and When to Incorporate PK Design into Your Gene Therapy Development Plan. Gene therapy, which was in its infancy around 30 years ago, is now becoming a more prominent treatment method in many therapeutic areas, from personalized therapy to mass vaccinations against COVID-19. Gene Therapy Definition.

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AstraZeneca broadens coronavirus vaccine manufacturing deal with Catalent

Bio Pharma Dive

Catalent, which is already helping the British pharma make its vaccine, will now add key services from a Maryland gene therapy plant.

Vaccine 273
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5 FDA decisions to watch in the second quarter

Bio Pharma Dive

By the end of June, the agency could clear a gene therapy for Duchenne muscular dystrophy and two vaccines for RSV, as well as issue a precedent-setting decision on a closely watched ALS drug.

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US FDA makes EUA changes to Pfizer-BioNTech and Moderna Covid-19 vaccines

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has made changes to the emergency use authorisations (EUAs) of the Pfizer -BioNTech and Moderna bivalent mRNA Covid-19 vaccines. The latest amendment aims to simplify the vaccination schedule for most people. The changes mean that the current bivalent vaccines for the original and Omicron BA.4/BA.5

Vaccine 334
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5 questions facing the FDA in 2021

Bio Pharma Dive

A new commissioner, high-stakes coronavirus vaccine reviews and a rising gene therapy workload will test the agency this year.

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US FDA grants Fast Track status for Pfizer-BioNTech’s combination vaccine

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted Fast Track designation for Pfizer and BioNTech’s messenger ribonucleic acid (mRNA)-based combination vaccine candidate against Covid-19 and influenza. The vaccine is intended to prevent two respiratory ailments through a single injection. 5 Omicron sublineages spike proteins.

Vaccine 289
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5 FDA decisions to watch in the third quarter

Bio Pharma Dive

Between July and September, the regulator could approve a first-of-its-kind autoimmune drug and two gene therapies as well as decide how COVID-19 vaccines should be updated.