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First patients dosed with Fasenra in three dermatology trials
With the addition of the new dermatology trials, Fasenra is now being evaluated in nine different indications associated with eosinophilic immune dysfunction.
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Biologics
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FDA halts COVID-19 vaccine production at Emergent facility
The FDA has requested Emergent’s Bayview plant be closed and vaccine production halted while the agency investigates potential good manufacturing practice (GMP) violations.
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Stem cell transplantation may be able to prevent major cause of death in preterm infants
Transplanting stem cells directly into the trachea of preterm infants with bronchopulmonary dysplasia was found to be safe and of some benefit in the most vulnerable group.
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EMA confirms Janssen COVID-19 Vaccine benefits outweigh clotting risks
The EMA’s drug safety committee has concluded that the Janssen COVID-19 Vaccine is safe for continued use, so Johnson & Johnson will resume shipments to the EU.
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Antibody-drug conjugates: challenges, solutions and future potential
The ability to precisely direct powerful therapeutics not only makes treatments more effective, but also prevents debilitating side effects. Here, Dave Elder and Stacey Treichler highlight the great potential of antibody-drug conjugates (ADCs) for improved treatment of oncology indications and beyond.
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Plasma-derived therapies require a mastery of advanced bioproduction techniques
Plasma-derived therapies and medicines provide life-changing treatments for patients around the world who suffer from serious, and often rare, diseases that affect the immune system or result from non-functioning proteins in blood plasma. Carole Resman, Executive Vice President Production at LFB, describes the complex and highly regulated manufacturing process of…
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Under the microscope: The challenge of quality control for adenovirus and RNA-based vaccines
Claudia Benati, Senior Scientific Director at Eurofins BioPharma Product Testing (Eurofins BPT) and Qualified person for Advanced Therapies (ATMPs), and Dr Anke McCartney, Global Key Account Manager, Eurofins BPT, discuss the challenges faced by the pharmaceutical industry in the field of analytical testing of COVID-19 vaccines in these unprecedented times…
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Formulation, Development & Delivery In-Depth Focus 2021
In this in-depth focus, experts discuss why nanoparticles are a promising alternative for delivering inflammatory bowel disease therapies and highlight the potential of antibody-drug conjugates to advance oncology treatment.
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Bioprocessing & Bioproduction In-Depth Focus 2021
Featured in this in-depth focus, articles exploring why cleanroom infrastructure must transform to meet the needs of the cell and gene therapy industry and discussing a novel platform for discovering and developing genetically-targeted therapies for autoimmune diseases.
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Manufacturing, Packaging & Logistics In-Depth Focus 2021
Download this in-depth focus to learn about how the logistics industry rose to the challenge of the COVID-19 vaccine rollout and the complexities of the production process for plasma derived therapies.
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How to overcome barriers in the adoption of microbiome-based therapies
This article from the global consulting firm Charles River Associates (CRA) describes how manufacturers must address and overcome three key barriers hindering progress in the microbiome sector and the optimal strategies needed to demonstrate the value of microbiome-based therapies in successful commercialisation.
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Pharmaceutical sterility testing market to value over $1000 million by 2027
Reports suggest the global sterility testing market will grow because of the expansion of pharma and biopharma, increasing R&D activities and the launch of new products.
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Novel blindness gene therapy shows promise in first-in-human trial
The lowest dose of the gene therapy was shown to be safe and somewhat improved vision in the first three patients treated in the trial.
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FDA revokes bamlanivimab Emergency Use Authorization
The Emergency Use Authorization (EUA) was revoked after data suggested that, in the US, the prevalence of variants likely to be resistant to the monoclonal antibody bamlanivimab alone is increasing.
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INO-4800 COVID-19 vaccine provides cross-reactive immune responses against variants
Antibodies induced by the investigational DNA vaccine candidate, INO-4800, were found to be able to neutralise three SARS-CoV-2 emerging variants of concern.
