Nitrosamines: the beginning of the end?
Dave Elder explores evolving concerns surrounding nitrosamine-related impurities while calling for continued collaboration to harmonise regulatory approaches.
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Dave Elder explores evolving concerns surrounding nitrosamine-related impurities while calling for continued collaboration to harmonise regulatory approaches.
Following Novo Nordisk’s announcement that its Wegovy injection for obesity demonstrated a 20 percent reduction in major adverse cardiovascular outcomes, the pharma giant has launched the semaglutide treatment in the UK.
Part of the £650 million ‘Life Sci for Growth’ funding package announced in May 2023, £5.5 million is set to deliver a new UK Medicines Manufacturing Skills Centre of Excellence to boost the skills of talent in the life sciences sector.
Researchers have described how a process analytical technologies (PAT) fluorescent dye (FD)-based microfluidic sensor facilitated immediate feedback and control of process parameters for continuous downstream processing.
Recommendation of Elfabrio® (pegunigalsidase alfa) means patients with Fabry disease in England will be able to access a new treatment option.
In Amgen’s consent order with the US Federal Trade Commission (FTC) addressing the intended acquisition of Horizon Therapeutics, once finalised, some requirements will be effective for 15 years.
EPR Issue 4 includes articles on fridge-free vaccines, dry powder drug delivery, Annex 1, contamination control strategy and more.
Roche has provided the first evidence that its oral anaplastic lymphoma kinase (ALK) inhibitor for non-small cell lung cancer (NSCLC) could be key in treating the early-stage disease.
As the pharmaceutical industry awaits the first regulatory approval of an mRNA-based oncology therapy, research predicts BioNTech will lead the market by 2029, which by then, is anticipated to value $2 billion.
Targeted radiotheranostics are on the path to becoming integral to cancer diagnosis and treatment. Their success, however, depends on patient benefit and the ability to meet commercial demands for broader indications. Aside from the therapeutic or diagnostic efficacy, decisions on suitable radionuclide properties and owning the supply chain will be…
IMA Pharma showcases its extensive, all-in-one vaccine production solutions, including the design and development of complete aseptic lines and secondary packaging, all facilitated by the latest advanced technologies.
Pfizer and BioNTech’s adapted Omicron XBB.1.5 COVID-19 vaccine has been recommended for two additional indications in the EU.
A Novartis’ Phase I/II study for sickle cell disease trialling the gene therapy OTQ92 is the first treatment to target a new genetic area and use cryopreserved stem cells, according to new paper published in NEMJ.
Key recommendations highlighted in a recent report by the Access to Medicine Foundation offer pharmaceutical manufacturers ways to effectively manage the release of antibiotic waste into the environment, and thus contribute to the reduction of antimicrobial resistance (AMR).
Advanced analytical technologies in quality control (QC) processes in cell and gene therapy manufacturing is anticipated to help deliver a 24.6 percent market CAGR between 2023 and 2031.