article
Nitrosamines analysis with LC/MS-MS
This ebook provides a comprehensive overview of nitrosamine analysis for the pharmaceutical industry.
List view / Grid view
Regs & Legs
news
FDA approves first cell-based gene therapies for sickle cell disease
The US FDA has approved Vertex’s Casgevy and bluebird bio’s Lyfgenia, for one-time treatment of sickle cell disease in patients 12 years and older.
news
GSK immuno-oncology treatment achieves novel EU approval
The EC’s approval of the immuno-oncology treatment “will define a new standard of care for certain patients with advanced or recurrent endometrial cancer in the EU,” says principal investigator of the RUBY trial.
news
MHRA authorises Mounjaro for weight management
The UK MHRA has authorised Eli Lilly's Mounjaro (tirzepatide) for weight loss and weight management in adults.
news
AbbVie to buy neuroscience specialist Cerevel Therapeutics for $8.7bn
AbbVie plans to acquire neuroscience specialist Cerevel Therapeutics for $45 per share, or around $8.7 billion.
news
Antibody-immunotherapy combination shows promise in lung cancer
A study evaluating the combination of a PD1 inhibitor with dupilumab enabled one out of six lung cancer patients to achieve a near-complete clinical response two months post-treatment, a paper states.
news
Novartis secures first-of-a-kind haematology approval
A novel Factor B inhibitor of the immune system's complement pathway has been approved for paroxysmal nocturnal haemoglobinuria (PNH).
whitepaper
Under the microscope: Scientifically sustainable endotoxin testing with Endosafe® Trillium™ recombinant cascade reagent (rCR)
Interested in scientifically sustainable endotoxin testing? Discover more about Endosafe® Trillium™ recombinant cascade reagent (rCR)
podcasts
EPR Podcast Episode 21 – Biosimilars – Salim Benkhalifa, Celltrion Healthcare France
In this podcast, Dr Salim Benkhalifa, Medical Affairs Lead, Celltrion Healthcare France reflects on biosimilars development.
news
Novel generalised myasthenia gravis treatment approved
A subcutaneous C5 complement inhibitor has been authorised by the European Commission (EC) as a treatment for generalised myasthenia gravis in Europe.
news
Survey reports on falsification of medical devices
1 December 2023 | By
Falsification of medical devices exists in Council of Europe member states, but there are few investigations and prosecutions, a new survey finds.
whitepaper
Application note: Equivalency of PCR-based rapid sterility testing and the compendial culture method
Sterility testing is a critical component of release testing for any cell therapy product since microbial contamination of cell therapy products can potentially kill recipients.
whitepaper
Whitepaper: The value and benefits of rapid mold detection in the pharmaceutical industry
Address the importance of accurate microbial identifications and proper contamination control for effective mold remediation.
news
First pill for desmoid tumours approved
Approval of the first treatment option for desmoid tumours beyond surgery and radiation has been granted by the US Food and Drug Administration (FDA).
whitepaper
Application note: Role of in-house isolates in pharmaceutical quality control
This application note addresses the need to evaluate key sources of contamination to maintain an optimum level of pharmaceutical quality control.
