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BioNTech to support trial access for cancer immunotherapies
Signing of a major agreement between BioNTech SE and the UK government for cancer trials means more patients could access personalised immunotherapies.
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Clinical research organisation market anticipated to reach $140bn by 2033
According to a report, growing demand for cost-effective and efficient drug development processes is propelling the global clinical research organisation (CRO) market.
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PDA revises report on glass container manufacturing
Parenteral Drug Association (PDA)'s 2023 technical report on nonconformities in glass containers during pharmaceutical manufacturing represents best practices for identification and classification.
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European Commission extends approval of cystic fibrosis medicine
For the first time, a medicine to treat the most common form of cystic fibrosis has been approved in paediatric patients aged one to under two years old.
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Novel oral therapy shows potential in plaque psoriasis
"Development of a novel oral therapy that specifically targets IL-23R could potentially change the treatment paradigm” in moderate-to-severe plaque psoriasis (PsO), stated a Janssen R&D VP.
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ISO publishes standard on bacterial endotoxin testing
Evaluation of bacterial endotoxin pyrogens is included in the International Organization for Standardization (ISO)’s new standard for microbiological methods.
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Could small molecule medicine treat rare liver disease?
A novel PPAR alpha/delta agonist “could provide an important new therapeutic option for long-term treatment [of primary biliary cholangitis (PBC)].
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FDA releases analysis on drug product quality in 2022
There continues to be a correlation between low site inspection scores and potential drug recalls, states the US Office of Pharmaceutical Quality (OPQ) 2022 annual report.
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Global PAT market expected to exceed $10b in 2032
Digitalisation is a driving factor for the global process analytical technology (PAT) market, according to a report.
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In Depth Focus QA/QC Microbiology/RMM 2023
This in-depth focus explores collaborative efforts to accelerate validation and adoption of rapid microbial methods across the pharmaceutical industry and the power of rapid methods for fungal ID.
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First gene therapy approved for Haemophilia A
The first approved gene therapy for haemophilia A reduced the mean annualised bleeding rate from 5.4 bleeds to 2.6 bleeds per year in a clinical study.
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First cell therapy approved for Type 1 diabetes
US Food and Drug Administration (FDA)-approved allogeneic pancreatic islet cell therapy Lantidra could provide another treatment option for Type 1 diabetes.
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First AI-generated small molecule drug enters Phase II trial
Insilico Medicine’s novel AI-generated small molecule inhibitor drug represents a new milestone in pharmaceutical drug development.
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Eli Lilly ulcerative colitis antibody drug doubles remission rates
Mirikizumab, the first therapeutic antibody tested for blocking interleukin-23 in ulcerative colitis has demonstrated strong efficacy in two Phase III trials.
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Reflecting on five years of quality control for nitrosamine impurities
Since the US Food and Drug Administration (FDA)’s report on a series of nitrosamine-related impurity drug recalls in 2018, pharma has made great strides in its ability to detect and control for these impurities. Dr Mrunal Jaywant, Vice President of R&D at USP India proposed a collaborative, cross-community approach between…
