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Experimental immunotherapy significantly delays onset of type 1 diabetes
If approved for use, teplizumab could be the first drug able to delay the onset or completely prevent type 1 diabetes in at-risk groups.
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US Food and Drug Administration (FDA)
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Merck to manufacture Janssen’s COVID-19 vaccine
Merck has entered into multiple agreements to support the expansion of the supply of COVID-19 medicines and vaccines.
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FDA approves the Janssen COVID-19 Vaccine for emergency use
The FDA has issued an Emergency Use Authorization for the single-dose Janssen COVID-19 Vaccine, making it the third COVID-19 vaccine available for use in the US.
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Tezepelumab significantly reduces exacerbations of severe asthma
In a Phase III trial, tezepelumab was shown to meaningfully reduce annualised asthma exacerbation rates in a range of patients with severe, uncontrolled asthma.
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Novel nanocarrier enables targeted treatment of gliomas in vivo
The new nanoparticle formulation enabled researchers to selectively target glioma cells with Dp44mT, a potent chelator and promising anti-cancer therapeutic, for the first time.
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Leukine® significantly improves lung function in hospitalised COVID-19 patients
In the trial Leukine® (sargramostim, rhuGM-CSF) improved oxygenation in COVID-19 patients with acute respiratory failure by at least a third in over half of those treated.
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Treatment for rare Duchenne muscular dystrophy mutation approved by FDA
The FDA conditionally approved Sarepta’s Amondys 45 (casimersen) after interim Phase III results indicated the treatment is reasonably likely to be of clinical benefit.
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FDA approves more flexible transportation conditions for Pfizer-BioNTech COVID-19 vaccine
Based on new stability data, the US regulator will allow COMIRNATY® to be transported and stored at standard pharmaceutical freezer temperatures for up to two weeks.
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Ide-cel provides lasting remissions in multiply-relapsed myeloma
BMS and bluebird bio have applied to the FDA for approval of ide-cel as a standard therapy for relapsed or refractory multiple myeloma based on positive Phase II trial results.
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FDA grants Priority Review to Pfizer’s tick-borne encephalitis vaccine TicoVac™
If approved, TicoVac would be the first vaccine in the US to help protect adults and children from tick-borne encephalitis.
![Lines of vials labelled 'COVID-19 Vaccines' [Credit: Dimitris Barletis/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Covid-19-vaccines-2-1-300x278.jpg)
![Lines of vials labelled 'COVID-19 Vaccines' [Credit: Dimitris Barletis/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Covid-19-vaccines-2-1-e1614176959561.jpg)
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FDA receives new stability data on Pfizer’s COVID-19 vaccine
New stability data could allow Pfizer and BioNTech’s COMIRNATY® COVID-19 vaccine to be stored at normal refrigerated temperatures for up to two weeks.
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FDA issues new guidance for developers of COVID-19 vaccines, diagnostics and therapeutics
The new recommendations address the evolving landscape of COVID-19 drug development, including the emergence of SARS-CoV-2 variants.
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FDA approves Libtayo® monotherapy for non-small cell lung cancer patients
The approval was based on a Phase III trial in which Libtayo reduced risk of death by 43 percent in non-small cell lung cancer patients with ≥50 percent PD-L1 expression in their tumours.
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Manufacturing of CAR T-cell therapies: an overview
The emergence of CAR T-cell therapies has ignited a revolution in the field of cancer treatments. While existing products show outstanding curative capability, they are hampered by significant clinical and commercial challenges, many of which stem from their manufacturing process. Maciej Nakoniecznik discusses how a combination of biological and technological advances…
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The importance of disaccharide excipients in biologics
Many biologic formulations use a variety of high-purity injectable grade disaccharide excipients to ensure functionality and stability of the final product. In this article, Sunil Kumar Nataraj, Bastiaan Dickhoff and Thontesh GC explore the use of these sugars in the stabilisation of biologics and provide recommendations to manufacturers for enhancing…
