All Pharmacovigilance and safety oversight articles – Page 19
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NewsVaccine demonstrates benefit in delaying cancer relapse
Data from the Phase I trial showed that the cancer vaccine offered an 86 percent reduction in the risk of relapse or death in pancreatic and colorectal cancers.
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NewsNew collaboration could transform neonatal therapy
With no currently approved medicines for the prevention of bronchopulmonary dysplasia (BPD) in extremely pre-term infants, a new pharmaceutical collaboration could produce the first major therapeutic breakthrough for this patient group in decades.
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NewsPositive data from schizophrenia clinical trials revealed
Newron Pharmaceuticals and Lyndra Therapeutics’ have announced positive data from key clinical trials in schizophrenia and schizoaffective disorder.
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NewsCollaboration to develop novel AI-designed oncology therapy
Stemline Therapeutics is set to pay Insilico Medicine an initial $12 million for its novel AI-designed KAT6 inhibitor as a potential breast cancer treatment.
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NewsPreventative approach could reduce immunotherapy side effects
Research suggests that giving prophylactic treatment prior to immunotherapy could eliminate the need for the latter to be administered in hospitals.
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NewsNovel drug delivery method shows promise in Alzheimer's
Ultrasound combined with a biologic treatment has demonstrated the ability to safely reduce brain amyloid plaques in the brains of Alzheimer’s patients, a first-in-human study shows.
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ArticleDeveloping micro QC for ATMPs
In this Q&A, Natalie Saunders, Interim Head of Quality Control at CGT Catapult, delves into the advancements and challenges in microbiological QC for cell and gene therapies. She discusses rapid sterility testing methods, regulatory frameworks, and the impact of automation and digitalisation on quality control.
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NewsMHRA authorisation is first endocrine therapy innovation in decades
A new breast cancer treatment that reduced the risk of progression or death by 45 percent compared to standard of care in a Phase III trial, has been authorised by the UK Medicines & Healthcare products Regulatory Agency (MHRA).
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ArticleLeveraging innate cell engagers for lymphoma treatment
In this interview, Andreas Harstrick, CMO of Affimed discusses the evolution of the lymphoma treatment landscape and the promise of innate cell engagers for treating cancer.
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NewsBMS strikes $14bn deal for Karuna Therapeutics
The deal includes Karuna Therapeutics' potential first-in-class antipsychotic, xanomeline-trospium, for patients with schizophrenia and other conditions.
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NewsSanofi stops development of lung cancer drug
Sanofi is discontinuing development of tusamitamab ravtansine for certain types of non-small cell lung cancer after a Phase III clinical trial did not meet its endpoint.
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NewsNICE recommends combination therapy for prostate cancer
Lynparza (olaparib), which is being co-developed by AstraZeneca and MSD, showed clinically meaningful benefit when used with abiraterone and prednisone or prednisolone to treat hormone-relapsed metastatic prostate cancer.
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NewsFDA grants priority review to omalizumab for food allergies
If approved, monoclonal antibody omalizumab would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure.
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ArticleBioburden and sterility testing: how to conserve gene therapy product
Here, Kathy Zagaroli, Senior Director of Quality Control at Kiniksa Pharmaceuticals, and Tom Bujold, Senior Director of Quality Control at REGENXBIO, discuss the challenges of bioburden and sterility testing for gene therapies and why industry must come together to drive increased harmonisation.
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ArticleYear in review: EPR’s top stories of 2023
EPR wraps up the year with a selection of top stories from 2023, highlighting key trends and topics such as environmental monitoring (EM), quality (QA/QC), manufacturing, regulation and clinical development.
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NewsCHMP issues positive option for first gene-editing medicine
If approved, Vertex’s Casgevy (exagamglogene autotemcel) would be the first gene-editing medicine authorised in the European Union.
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NewsAstellas secures EC approval for VMS treatment, fezolinetant
Approval of fezolinetant gives patients in Europe a new nonhormonal treatment option to control hot flashes or night sweats associated with menopause.
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ArticleUnderstanding the evidence used in drug product withdrawals
Samantha Lane, Head of Research for the Centre of Pharmacovigilance Sciences at the Drug Safety Research Unit discusses drug product withdrawals and the regulatory shift to a greater reliance on epidemiological and observational research as evidence for these decisions within Europe.
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NewsEC approves treatment for rare haematological disorder
The European Commission has approved Europe's first treatment for adults with indolent systemic mastocytosis, a rare haematological disorder.
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ArticleNK cell immunotherapy: what’s next in clinical development?
In this interview, Innate Pharma’s Yannis Morel, Executive Vice President of product portfolio strategy and business development, delves into the unique advantages of using multi-specific antibodies capable of engaging NK cells against tumours for oncology indications, and shares key data from the company’s ongoing and recent clinical trials.