news
WHO issues alert for falsified COVID-19 vaccine
The World Health Organization (WHO) has warned that a falsified COVID-19 vaccine, identified as Pfizer’s BNT162b2, could still be in circulation in the Americas.
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Biologics
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FDA approves Abecma, the first cell-based gene therapy for adults with multiple myeloma
Abecma (idecabtagene vicleucel) was approved for adults with relapsed or refractory myeloma based on its 72 percent overall response rate in a trial.
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EMA approves increased manufacturing capacity for COVID-19 vaccines
The approval of at least one new manufacturing site based in Europe for each of the approved COVID-19 vaccines should increase supply for the EU.
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AstraZeneca confirms COVID-19 vaccine efficacy with primary analysis
Following DSMB concerns about the data released regarding the Phase III US trial, AstraZeneca has now confirmed that its vaccine is 76 percent effective against symptomatic COVID-19.
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EMA accepts regulatory submission for Takeda’s dengue vaccine candidate
The submission is the first in a series that will include dengue-endemic countries, it includes long-term Phase III safety and efficacy data for the TAK-003 vaccine candidate.
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Could viral vector shortages disrupt the COVID-19 vaccine roll-out?
According to GlobalData, AstraZeneca’s and Janssen’s COVID-19 vaccines could be impacted by global viral vector shortages.
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Why real-time environmental monitoring is the most important aspect of the modern pharmaceutical cold chain
Glenn Abood, founder and CEO of rfxcel, explains how real-time environmental monitoring can combat supply chain shortcomings, providing companies with level of data integrity, traceability, transparency and security that is virtually beyond reproach.
news
US finds COVID-19 Vaccine AstraZeneca safe and effective
An analysis of results from 20,000 vaccinnees shows AstraZeneca’s vaccine completely prevents severe or critical COVID-19 and hospitalisation.
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REGEN-COV™ antibody cocktail reduces hospitalisation or death by 70 percent
Phase III data shows treatment with REGEN-COV™ (casirivimab and imdevimab) significantly reduces the risk of high-risk COVID-19 infected outpatients being hospitalised or dying.
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Using albumin could facilitate vaccination by inhalation, finds pre-clinical study
MIT researchers developed and tested in mice intratracheal vaccines to protect against the vaccinia virus and the formation of lung cancer.
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How has COVID-19 impacted the development of cell and gene therapies?
European Pharmaceutical Review’s Hannah Balfour explores the findings of the Cell and Gene Therapy (CGT) Catapult’s 2020 advanced therapy medicinal product trials report and discusses how the European and global CGT markets are expected to perform in coming years.
video
On-demand webinar: Highway to clinic: Formulation strategies for improved bioavailability
With the appropriate formulation strategies, the challenges around poorly soluble compounds can indeed be overcome. Reducing development time and ultimately speeding up the route to market.
webinar
Emerging tools for the analysis of biologics and biosimilars
22 March 2021 | By Bruker Biospin Group
In this virtual roundtable, experts explore the uses of nuclear magnetic resonance (NMR) in the analysis of biologics and biosimilars and discuss how recent advances are changing the game.
whitepaper
Whitepaper: EU GMP Annex – sterile manufacturing
This whitepaper considers the latest EU GMP Annex 1 draft and its impact on the control and release of sterile products.
video
On-demand webinar: Testing disinfectant agents for antimicrobial action on hard surfaces
Disinfectants must be qualified on the surfaces in a pharmacopeial manufacturing environment prior to use in the facility. Building a study with robust parameters and avoiding common pitfalls is critical to avoid negative responses from regulatory agencies.
