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EMA COVID-19 treatment evaluations update
The EMA has begun a rolling review of Celltrion’s regdanvimab (CT-P59) antibody for COVID-19 and assessing new data on Veklury (remdesivir).
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Therapeutics
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Novel anti-psychotic shows promise in Phase II schizophrenia trial
KarXT significantly reduced both positive and negative of symptoms of schizophrenia without the common problematic side effects of current antipsychotic therapies.
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Partnership to develop a microneedle patch for delivering psychedelic pharmaceuticals
The Terasaki Institute is partnering with PharmaTher to adapt a microneedle drug delivery patch for the micro-dosing of psychedelics.
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EMA’s transformative treatments of 2020
In this article, we summarise the trial findings for the European Medicines Agency’s 13 most transformative therapies of 2020.
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Upadacitinib meets all endpoints in Phase III ulcerative colitis trial
In the trial, 74 percent of participants responded to upadacitinib and 33 percent of patients achieved clinical remission.
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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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Scientists repair spinal cord injuries using patients’ stem cells
In a Phase II trial, all 13 patients who received an intravenous infusion of their own mesenchymal stem cells had improvements in neurological function six months later.
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Gates Foundation to fund Novartis’ development of a sickle cell disease gene therapy
The Gates Foundation will fund Novartis’ discovery and development of a gene therapy for sickle cell disease that is accessible for low- and middle-income countries.
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IMU-838 shows some clinical benefit in moderate COVID-19 patients
The oral treatment slightly shortened time to clinical improvement and recovery in a Phase II trial, with greatest benefits in high-risk and elderly COVID-19 patients.
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Marketing of Zynteglo suspended as precaution due to potential cancer risk
bluebird bio has chosen to suspend sales of Zynteglo while they investigate whether safety concerns identified with a related investigational gene therapy may apply to the licenced medicine.
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The current and future landscape of HIV treatments and vaccines
Dr Caroline Forkin from ICON discusses the current status of HIV treatments and potential for researchers to develop a vaccine.
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Biosimilar uptake: a clinician’s perspective
To ensure that clinicians buy into biosimilars, it is important that they understand how products are analysed and compared to the originator molecules. Dr Fraser Cummings and Jonathan Sweeting discussed this issue at a recent virtual roundtable event, where they highlighted the complexities of biosimilar development pathways and approval processes. Here, Nikki Withers shares the…
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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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Sourcing of active pharmaceutical ingredients
Considerations when sourcing active pharmaceutical ingredients (APIs) can often be condensed to ones of economy and purity. Here, Dave Elder highlights the importance of defining those attributes that impact final product quality to ensure pharma companies find the best ingredient suppliers.
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Chemspec Europe 2021 postponed
The 35th International Exhibition for Fine and Speciality Chemicals will now take place as live and digital hybrid event from 29 to 30 September 2021.
