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New draft guidance promotes diversity in clinical trials
FDA’s new draft guidance follows the new requirement for clinical study sponsors to submit Diversity Action Plans, eg, when submitting their investigational new drug (IND) application.
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Clinical Trials
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Drug approval roundup – May/June 2024
This article highlights some of the key regulatory approvals granted in May and June in the EU and US so far this year, including for oligonucleotide and biologic therapies.
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New multiple sclerosis treatment option granted in EU
The newly authorised formulation of the anti-CD20 therapy provides certain multiple sclerosis patients with another treatment option comparable to intravenous infusion.
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Gilead small molecule demonstrates strong capability for HIV prevention
According to Gilead, the study is the first Phase III HIV prevention trial to demonstrate a zero-infection rate.
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Non-chemotherapy lymphoma treatment may provide durable remission
Fifty four percent of evaluable patients with DLBCL attained a substantial tumour reduction with the five-drug regimen, trial data shows.
webinar
Defining the right digital strategy for oncology: What do you want to measure?
19 June 2024 | By Medable
In this webinar, find out how to optimise oncology clinical trials using digital tools to accelerate decision-making.
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Novel immunotherapy combination approved for endometrial cancer
The new approval of KEYTRUDA (pembrolizumab) combined with chemotherapy is indicated for certain patients with the most common gynaecologic cancer, according to Merck/MSD.
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Haemophilia drug could reduce treated bleeding episodes
Once-weekly or once-monthly dosing of Mim8 provides optionality and flexibility for people living with haemophilia A with or without inhibitors, stated Novo Nordisk’s EVP for Development.
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Modifier gene therapy – clinical development and manufacturing considerations
Expanding on his earlier podcast discussion with EPR, Dr Arun Upadhyay, Chief Scientific Officer and Head of Research & Development at Ocugen, discusses the company’s promising modifier gene therapy candidates for ophthalmic disorders.
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Five-year data from Genentech SMA study released
Spinal muscular atrophy (SMA) patients in the long-term extension Evrysdi study maintained or improved key developmental skills over the five-year period, data shows.
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GLP-1 treatment displays best-in-class potential for MASH
These results from the Phase II trial could lead to clinically meaningful benefits for cardiovascular, renal, and metabolic diseases, Boehringer Ingelheim suggests.
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Regulation and legislation in the era of automation and digitalisation
Experts at IP firm Finnegan discuss if the pharmaceutical industry is ready for the innovation and technologies that digitalisation and automation will bring, and whether these advances are a threat or ally to intellectual property rights in the sector.
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Combination therapy may hold potential for severe viral hepatitis
New findings from a Phase II study suggest the curative potential of a combination treatment for chronic hepatitis delta virus, according to Gilead Sciences.
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Advancing targeted treatments for multiple myeloma
Edmond Chan, Senior Director, EMEA Therapeutic Area Lead, Haemato-Oncology, Johnson & Johnson Innovative Medicines, offers insight into the promising evidence of cell therapies and biologic-based treatments for patients with multiple myeloma.
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Biologic demonstrates durable tumour regression in rectal cancer
The updated, longer-term Phase II trial results suggest that the antibody therapy could offer a novel approach for treating advanced rectal cancer.
