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Included in the revised ISO 10993-17 guideline are requirements for toxicological risk assessment of medical device constituents, such as extractables and leachables (E&L).
To ensure timely market entry of generics and biosimilars in the EU, the Supplementary Protection Certificate (SPC) Manufacturing Waiver must be clearer, asserts Medicines for Europe.
Approval of the first treatment for patients one year old and over with eosinophilic esophagitis (EoE) was based on trial data showing a greater proportion of children given Dupixent achieved histological remission compared to placebo.
UK scientists have unlocked the potential of bioengineering vaccine adjuvants, based on a study of the molecule QS-21.
Following her leading contribution in key manufacturing and quality projects in Ireland and the US, Eli Lilly and Company’s Executive Vice President (EVP) of Global Quality is set to retire after nearly 35 years of service.
In draft guidance on quality considerations for topical ophthalmic drug products, the US Food and Drug Administration (FDA) provided recommendations for E&L testing.
Phase III data for Janssen’s innovative IL-23 inhibitor has revealed that the biologic is effective for adults with moderate to severe plaque psoriasis (PsO) across all skin tones.
Uncover the pivotal role of isolator technology in enhancing safety and productivity in the pharmaceutical and chemical industries.
Under its newly agreed acquisition, Sanofi is to acquire Inhibrx, Inc., adding INBRX-101 to its portfolio, a therapy that could improve the treatment options available for alpha-1 antitrypsin deficiency (AATD).
EPR's inaugural Pharma Horizons report explores the latest advances in artificial intelligence (AI) and machine learning (ML) for drug development, pharmaceutical manufacturing and quality control.
Aptamers offer a “cutting-edge approach” for identifying gram-negative bacterial pathogens, a paper suggests.
23 January 2024 | By Particle Measuring Systems
Watch this webinar as GMP expert Mark Hallworth discusses the difference between cleanroom classification and monitoring of the new ISO 14644 Technical Report 21 focuses in section 4.0 and 5.2.
An effective analytical framework for a broad spectrum of monoclonal antibodies (mAbs) and complex mAb biotherapeutics has been developed, according to a recent study.
The rising demand for biopharmaceuticals and a greater focus on cross-contamination are two of the biggest factors expected to impact the extractable and leachable (E&L) testing services market between 2023 and 2030, research predicts.
The first BRCA-targeted treatment has been recommended for advanced breast or metastatic breast cancer by the National Institute for Health and Care Excellence (NICE).
