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mRNA vaccine candidates for HIV enter Phase I trial
Will mRNA vaccines one day protect against HIV? Three investigational mRNA vaccines, all designed to combat HIV, have entered Phase I testing.
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Biologics
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Could AAT be the answer to COVID-19 ARDS?
Clinical study finds alpha-1 antitryspin (AAT) reduces pro-inflammatory IL-6 and therefore may benefit COVID-19 patients with Acute Respiratory Distress Syndrome (ARDS).
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, March 2022
EMA’s pharmacovigilance committee recommends product information updates for two COVID-19 vaccines - Janssen COVID-19 Vaccine and Moderna’s Spikevax.
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New agreement makes “Africa’s own COVID-19 vaccine” a reality
Under a new agreement with J&J, Aspen SA Operations will be able to manufacture and make available Aspen-branded COVID-19 vaccines in Africa.
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Trodelvy® improves breast cancer progression-free survival, finds study
Trodelvy® (sacituzumab govitecan-hziy) was found to significantly reduce the risk of disease progression or death in certain breast cancer patients.
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Chikungunya vaccine candidate safe and immunogenic in Phase III
Valneva’s single-shot chikungunya vaccine candidate, VLA1553, offered a very high level of seroprotection in all adults, including the elderly.
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PRIME scheme benefits drug development, finds EMA report
The report outlines the positive impact the EMA’s PRIority Medicines (PRIME) scheme has had on drug development for unmet medical need over the last five years.
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Nirsevimab first potential immunisation to protect against RSV in infants
Nirsevimab has the potential to offer RSV protection for all infants, with a single dose showing 74.5 percent efficacy in the Melody Phase III trial.
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Clostridioides difficile vaccine shows promise in Phase III trial
Pfizer’s investigational C. difficile vaccine was shown to reduce the duration and severity of disease, but not prevent primary C. difficile infection.
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FDA approves Carvykti for patients with multiple myeloma
US FDA approval based on 98 percent response rate in multiple myeloma patients treated once with Carvykti (ciltacabtagene autoleucel, cilta-cel).
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USP calls for industry input in developing mRNA quality guidelines
USP is developing mRNA quality guidelines to support the development of innovative medicines and vaccines.
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EMA’s human medicines committee (CHMP) Feb meeting highlights
Highlights of the February 2022 meeting of EMA’s human medicines committee (CHMP) include the recommendation of 13 medicines for approval, along with updates to other drugs and COVID-19 vaccines.
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Lilly to create $700mn Institute for Genetic Medicine
Investing $700mn to establish a new site, Eli Lilly plans to fuel the development of genetic medicines through the company’s new Institute for Genetic Medicine.
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β-thalassemia patients achieve transfusion independence with gene therapy
Over 90 percent of β-thalassemia patients treated with Betibeglogene autotemcel (beti-cel) achieved transfusion independence lasting over a year.
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Challenges in downstream purification of advanced therapies
John Liddell, Chief Technologist at the Centre for Process Innovation (CPI), writes about the challenges associated with gene therapy products, which constitute a major portion of the overall cell and gene therapy market.
