All Pharmacovigilance and safety oversight articles – Page 12
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ArticleProdrugs: seeking perfection in an imperfect world
Balancing safety, efficacy and cost in drug development is challenging. Prodrugs offer potential solutions, but also introduce additional complexities, as Dave Elder explains.
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ArticleQA/QC Microbiology In-Depth Focus 2024
This in-depth focus features articles on single temperature incubation, endotoxin standards and aseptic connections in pharmaceutical manufacturing.
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ArticleEuropean Pharmaceutical Review Issue 3 2024
European Pharmaceutical Review Issue 3 includes articles on microbiology, downstream bioprocessing and drug development. Register your details now to download this exclusive content.
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ArticleDrug 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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NewsNew 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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NewsGilead 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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ArticleBig potential for small molecule drugs in cancer treatment
With recent recommendation of Takeda’s fruquintinib by the European Medicines Agency (EMA), EPR spoke to Dr Sebastian Stintzing, Professor of Medicine, Head of the Department of Hematology, Oncology, and Tumor Immunology (CCM) of The Charité University Hospital in Berlin and investigator on the FRESCO-2 trial, to find out more about ...
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NewsNon-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.
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NewsHaemophilia 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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ArticleModifier 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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NewsAnalysis of chiral compounds using supercritical fluid chromatography
Sub/supercritical fluid chromatography is becoming a “dominant” technique for enantiomeric separation, especially purification, the researchers explained.
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NewsFive-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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NewsGLP-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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NewsFirst-in-class telomerase inhibitor approved for blood cancer
The FDA’s regulatory approval of the telomerase inhibitor is welcome, considering the high unmet need for many lower-risk myelodysplastic syndromes (LR-MDS) patients, according to Geron.
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NewsCombination 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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ArticleAdvancing 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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NewsBiologic 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.
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NewsAstraZeneca immunotherapy could boost lung cancer survival
Over half of patients were alive three years post-treatment with the monoclonal antibody (mAb) in AstraZeneca’s Phase III trial, data shows.
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NewsOligonucleotide ALS therapy approved in EU
The European Commission (EC) has granted Biogen its third rare disease treatment approval in the European Union.
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ArticlePioneering AAV gene therapy for Krabbe disease
Dr Maria Escolar, Chief Medical Officer, Forge Biologics, explores the advantages of the company’s novel AAV gene therapy for Krabbe disease, which could help to overcome some of the immune and safety challenges the gene therapy sector is facing.