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IV suramin may be a promising autism treatment, shows Phase II study
PaxMedica's intravenous (IV) suramin known as PAX-101 had mixed results in Phase II study, but shows potential to reduce autism symptoms.
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FDA joins Bespoke Gene Therapy Consortium (BGTC) for rare diseases
The consortium also consists of 10 pharmaceutical companies and five organisations to accelerate gene therapies to treat rare diseases.
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Continuous biomanufacturing – where are we now?
The biopharmaceutical industry is driven by the need to increase production and reduce costs, while maintaining product quality – and has increasingly been focused on intensification of processes to accomplish this goal. In this article, European Pharmaceutical Review’s Hannah Balfour summarises the potential benefits of implementing continuous bioprocessing and manufacturing…
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Serial radiation therapy an effective alternative for kidney cancer
The single-arm study showed that radiation therapy is an effective noninvasive alternative treatment for renal cell carcinoma (RCC).
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Stelara® shows promise to treat gut diseases in new analyses
Two new analyses displayed positive data supporting Stelara for the treatment of Crohn's disease and ulcerative colitis.
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Towards a solution for the access challenges faced by combination treatments
In this article, Takeda UK present their Value Attribution and Voluntary Arbitration Frameworks, a potential solution for the combination treatment challenge.
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SEC-MS: a “powerful tool” for ADC analysis, find researchers
Research shows size exclusion chromatography (SEC) with mass spectrometry (MS) enables the simple, quick and reliable analysis of antibody-drug conjugates (ADCs).
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Co-creating solutions that advance global health innovation – IFPMA’s role
The COVID-19 pandemic has altered and continues to shape our lives. Here, Thomas B Cueni, Director General of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), gives insight into how the pandemic gave impetus to the organisation’s manifesto to innovate and save lives.
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NICE does not recommend tucatinib in new draft guidance
The UK regulator concluded that breast cancer patients taking tucatinib live longer, but it is unclear how long for and whether it is cost effective.
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Model accurately predicts cyclodextrin formulation stability
The model determines cyclodextrin complex stability constants as a function of pH and temperature, helping to optimise formulations using cyclodextrin.
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CHMP initiates rolling review of molnupiravir for COVID-19
The European Medicines Agency's human medicines committee (CHMP) begins its rolling review of the investigational oral antiviral molnupiravir.
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Manufacturing, Packaging & Logistics In-Depth Focus 2021
In this in-depth focus experts describe the development of an effervescent multivitamin formulation stable enough for direct compression tableting and how packaging could benefit big pharma.
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Second Phase III study supports Dupixent® for eosinophilic oesophagitis
Dupixent® reduced eosinophilic oesophagitis symptoms by 64 percent compared to placebo and met primary endpoints in second Phase III study.
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Formulation, Development & Delivery In-Depth Focus 2021
Discover how to plan for post‑market clinical follow-up compliance under the new EU Medical Device Regulation (MDR), and formulate live biotherapeutic products to enhance their effects in this in-depth focus.
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Opdivo® approved in Europe to treat a range of cancers
Opdivo® (nivolumab) has been approved by the European Commission for gastric, gastroesophageal junction (GEJ), or oesophageal adenocarcinoma.
