All Pharmacovigilance and safety oversight articles – Page 13
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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.
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NewsLBP-immunotherapy could benefit oncology patients
New data for a microbiome-based therapeutic together with an immune checkpoint inhibitor has shown “encouraging clinical benefits” in advanced cancers.
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NewsTwo novel biosimilars approved in EU and US
The first omalizumab biosimilar in allergic diseases is approved by the European Commission and the US Food and Drug Administration (FDA) has authorised the fifty third biosimilar in the US.
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NewsLignin-based drug delivery system may improve chemotherapeutics
A sustainable drug delivery method based on the biopolymer lignin could offer applications in anti-cancer therapies, research suggests.
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NewsImproving stem cell transplantation success in high-risk blood cancers
The new medicine is expected to enable over 99 percent of people from a wide range of racial/ethnic groups to find a donor, research says.
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NewsNew Phase III data for hidradenitis suppurativa biologic released
The IL-17A and IL–17F inhibitor demonstrated positive efficacy and safety in adults with moderate-to-severe hidradenitis suppurativa, new data shows.
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NewsInnovative analytical method for quality control of nanomedicines
The research on nanomedicines investigated the intrinsic radiothermal emission of nanodrugs using a novel method.
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NewsSanofi releases new data for innovative oral asthma treatment
New findings from a Sanofi trial highlight promise for the potential first advanced oral treatment for moderate-to-severe asthma.
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NewsEuropean Commission grants first-of-a-kind biosimilar approval
The approval means Sandoz’s Wyost® and Jubbonti® are the first biosimilars of denosumab authorised in Europe.
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ArticleICH Q14 – latest guideline on analytical procedure development
Here, Dave Elder delves into the newly issued ICH Q14 guidance on analytical procedure development, discussing its impact during commercial phases as well as clinical development.
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NewsMSD collaboration to drive development of solid tumour combination therapy
The EGFR immune engager in combination with pembrolizumab is expected to be administered to the first patients in late 2024.
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NewsNovel biologic could offer ulcerative colitis symptomatic remission
Johnson & Johnson’s selective IL-23 inhibitor demonstrated clinically meaningful improvements compared to placebo in ulcerative colitis, new study data shows.
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NewsUK clinical trial regulation may support haemophilia treatment access
The new Notification scheme by the MHRA helps to reduce the time it takes for the lowest-risk clinical trials to commence, while maintaining patient safety.
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NewsEMA recommends suspension of hydroxyprogesterone caproate medicines
The recommendation comes after studies raised possible safety concern and found 17-OHPC is not effective in preventing premature birth.
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NewsEnsuring sterility of a novel anti-VEGF bispecific antibody
Safety of the compounded biologic was confirmed following 28-day storage in two different polypropylene syringe types, research shows.