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Navigating Regulatory Hurdles in Drug Development

DrugBank

In 2020, the FDA halted Johnson & Johnson’s COVID-19 vaccine production at a contract manufacturing facility after discovering quality control issues. One notable success story is Moderna’s mRNA vaccine development for COVID-19, which benefited from early regulatory engagement and streamlined approval pathways.

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Levers for Biological Progress

Codon

Such models will, in turn, make it much easier to invent the sorts of platform tools that Amodei asserts “drive >50% of progress in biology,” such as CRISPR and mRNA vaccines, because the creation of these tools ultimately derive from a deeper understanding of how cells work. In short, culture is an oft-overlooked bottleneck.

DNA
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Incyte replaces CEO Hoppenot with dealmaker Meury

BioPharma Drive: Drug Pricing

“During Hervé’s tenure, Incyte launched six novel medicines plus two new indications for Jakafi, expanded commercial operations into Europe, Japan and Canada and grew revenues from $355 million dollars in 2013 to $4.2 says US won’t donate to global vaccine effort View all Events 07 JUL Webinar | 10 a.m. billion today.”

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HOOKIPA Announces Positive Phase 2 Interim Safety, Immunogenicity, and Efficacy Data for its Cytomegalovirus Vaccine Candidate HB-101

The Pharma Data

Early interim data show Cytomegalovirus (CMV)-negative kidney transplant recipients vaccinated with three doses of HB-101 had reduced incidence of CMV viremia, reduced antiviral use and no CMV disease. 21 participants were vaccinated with HB-101 and 12 received placebo. NEW YORK and VIENNA, Austria, Nov.

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Article FDA Thank You Vaccines advisory panel endorses move to trivalent formulation for U.S. flu vaccines

Agency IQ

Vaccines advisory panel endorses move to trivalent formulation for U.S. flu vaccines Yesterday, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) weighed in on strains for seasonal influenza vaccines for the Northern hemisphere 2024-2025 season.

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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).

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Spade SB-66

The Pharma Data

Evidence-Based Complementary and Alternative Medicine, 2013. [15] And I can’t wait to hear about the difference Spade SB-66 has made in your life. [14] 14] Ambiye, V. Langade, D., Aptikar, P., Kulkarni, M., & Dongre, A. 15] Dongre, S., Langade, D., & Bhattacharyya, S. BioMed research international, 2015. [16] 16] Choudhary, B.,