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Looking ahead for cell and gene therapy

Drug Discovery World

Emphasis on manufacturing Experts were unanimous in their view of how far the cell & gene therapy (CGT) sector has come and the milestones achieved in both 2023 and early 2024, most referencing the first FDA-approved CRISPR therapeutic and the impact this will have on in-progress CRISPR clinical trials.

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ImmunityBio’s hAd5 T-Cell COVID-19 Vaccine Candidate Shows Complete Protection of Airways in Non-Human Primates

The Pharma Data

–( BUSINESS WIRE )– ImmunityBio , a privately-held immunotherapy company, today announced its COVID-19 vaccine candidate protected nasal and lung airways of non-human primates against coronavirus (SARS-CoV-2) in a challenge study. 11, 2020 02:48 UTC. CULVER CITY, Calif.–(

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FDA Authorizes Phase 1 Trial of ImmunityBio’s Novel COVID-19 Vaccine Candidate hAd5; Dual Construct is Designed to Drive Both T Cell and Antibody Immunity

The Pharma Data

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2).

Vaccine 52
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ChEMBL 34 is out!

The ChEMBL-og

71 out of the 882 newly added EMA drugs are only authorised by EMA, rather than from other regulatory bodies e.g. FDA. If the USAN/INN name assignment is ambiguous, the FDA GSRS preferred name is used. A company research code, or Clinical Trial intervention name, is assigned if no standardised name is available.

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GSK announces FDA approval for Nucala (mepolizumab) for use in adults with chronic rhinosinusitis with nasal polyps

The Pharma Data

Additionally, mepolizumab was the first biologic therapy indicated for adults with eosinophilic granulomatosis with polyangiitis (EGPA) and also the first biologic to be approved for patients aged 12 years and older with hypereosinophilic syndrome (HES). With 41 clinical trials, mepolizumab has been studied in over 4,000 patients.

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Article FDA Thank You FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version

Agency IQ

FDA’s guidance on developing products to prevent or treat Covid-19 Of the five guidance documents that received an extension, one addresses the development of drugs and biological products for Covid-19. It also stated that companies should consider whether an investigational product might interact with an administered vaccine for Covid-19.

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Analysis Life Sciences Thank You The U.S. regulatory landscape for probiotics and other microbiome-based therapies

Agency IQ

So what about all of the “biotic” terms that pop up in the news, on products labels and even in FDA warning letters? Unfortunately, there is no regulatory body that governs the terminology used in this space, although there are definitions that are generally accepted by the scientific community.