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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NICE does not recommend tucatinib in new draft guidance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.
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Dupixent® reduces itch by 37 percent in prurigo nodularis patients
Dupixent® is the first biologic to significantly reduce itch and skin lesions in Phase III trial for prurigo nodularis.
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Stabiliser-free PLGA nanoparticle formulation shows promise for drug delivery
Scientists have developed a stabiliser-free, non-toxic poly(lactic-co-glycolic acid) (PLGA) nanoparticle formulation for use in drug and vaccine delivery.
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Tirzepatide maintains AC1 and weight control in type 2 diabetes patients
The highest dose of tirzepatide led to an A1C reduction of 2.58 percent and reduced body weight by 11.7kg in Phase III study.
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European Pharmaceutical Review Issue 5 2021
Articles in this issue discuss the importance of diversity and inclusion in pharma, how packaging can improve big pharma's bottom line and why innovation has been vital to saving lives during the COVID-19 pandemic. Also in this journal, 10 key considerations when creating an ATMP manufacturing facility and how to…
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Interferon treatment reduces leukaemia recurrence by 20 percent
Interferon treatment with a bone marrow transplant bolstered outcomes for patients with advanced, high-risk leukaemia.
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Imfinzi™ improves liver cancer survival in Phase III trial
Imfinzi (durvalumab) demonstrated a meaningful overall survival (OS) benefit versus sorafenib as a first-line treatment for liver cancer.
