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Allucent to expedite Covid-19 booster vaccines development

Pharmaceutical Business Review

These candidates are being developed to offer better protection, extend the duration in preventing illness and transmission, as compared to the current vaccine technologies. As part of the contract, Allucent will initiate a Phase IIb clinical trial of 10,000 participants under BARDA’s Clinical Studies Network.

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COVID-19 has propelled the regulatory industry years ahead

pharmaphorum

The development of COVID-19 vaccines required levels of cooperation and pioneering science comparable to the Apollo space programme. Within 12 months of the outbreak, vaccines were being deployed to prevent severe infections, hospitalisation, and death. billion people have been fully vaccinated. COVID-19 vaccine tracker.

Vaccines 143
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2022 in review: Drug development milestones for tropical diseases

Pharmaceutical Technology

Novel therapeutics and vaccines for malaria. This year saw great progress towards making new therapeutics for malaria available sooner rather than later, says Karen Barnes, PhD, professor at the University of Cape Town’s Division of Clinical Pharmacology. Pyramax was codeveloped by MMV and the South Korean company Shin Poong.

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The ‘failure’ of clinical trials in the search for COVID-19 treatments

pharmaphorum

The picture is hardly more promising for vaccines: the number of approaches, difficulty in finding patients in which to carry out pivotal trials, irrelevant choice of endpoints … the outlook is far from promising. The M&S approach should be integrative, from the molecular level to the clinical and population outcomes.

Vaccines 105
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AdComms – Is FDA Getting Less Advice?

Eye on FDA

FDA has had its reputation tested not only by that decision but by the events of the past few years that called into question a possible politicization of the process and all of the misinformation around COVID-19 and vaccinations. The most active of these committees with vacancies this year has been the Oncologic Drugs Advisory Committee.

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Lipid Nanoparticles Immunogenicity & Toxicity | December 6-8, 2022

pharmaphorum

Following the success of LNP-mRNA vaccines, we have seen an influx of novel types of lipids based nanocarriers over the last 12 months, progress has been made to minimize immuno-toxicity challenges – from maximizing therapeutic window to fine-tuning the immune response. .

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FDA Advisory Committee Review of 2021

Eye on FDA

Of note, this tally does not include meetings of the Vaccines and Related Biologic Products Advisory Committee held to consider a recommendation for COVID-19 vaccines, but includes only drugs and biologics. FDA Adcomms have been declining in number even as the agency approves more drugs.