Small molecule treatment reduces risk of death by half in NSCLC
Astrazeneca’s small molecule tyrosine kinase inhibitor reduced the risk of death by 51 percent in non-small cell lung cancer (NSCLC), a major Phase III study has shown.
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New AMR certification launched for antibiotic manufacturers
Following publication of the Antibiotic Manufacturing Standard in 2022 to help overcome AMR, antibiotic manufacturers can now verify their actions through a new certification.
Study identifies key contamination source during ATMP manufacture
Researchers say they are the first to demonstrate contamination of over 40 percent of lipoaspirate samples for adipose tissue-derived stem cell (ADSC)-based advanced therapy medicinal product (ATMP) manufacture.
Analysis reports nitrosamine prevalence in small molecule drugs
Data from a paper on small molecule drugs has indicated nitrosamines in pharmaceuticals is likely more prevalent than originally expected.
Nivolumab plus chemo provides one-year PFS in 94 percent lymphoma patients
A PD-1 checkpoint inhibitor plus chemotherapy is expected to become new standard of care for advanced Hodgkin lymphoma, based on Phase III trial data.
Novel PAT system could enable adaptive process control
A paper has demonstrated a novel refractometry-based process analytical technology (PAT) system has potential for enabling adaptive process control in CGT manufacturing.
Sandoz to move headquarters to Basel, Switzerland
As Sandoz prepares to become standalone company, the generic and biosimilar firm has declared it will base itself in Basel, facilitating closer collaboration.
New UK drug delivery centre to support RNA therapeutic development
To develop new lipid nanoparticle formulations for RNA therapeutic delivery technologies, CPI and partners are working to establish a new UK Intracellular Drug Delivery Centre.
NICE recommends oral migraine treatment for first time
An oral small molecule CGRP antagonist has been recommended for episodic migraines in National Institute for Health and Care Excellence (NICE) final draft guidance.
Microfluidic device detects bacteria concentration from small sample volumes
A novel ultrasonic nanosieve enabled concentration of bacteria into a 1µL highly concentrated solution suitable for plate counting and PCR, according to research.
CRISPR-based microbial gene therapy delivers promise
A microbial gene therapy can “eliminate antibiotic-resistant E. coli strains in the gut”, according to first-in-human study interim results.
Big Pharma inventory management trends revealed
Rapid growth of Big Pharma manufacturer inventories fail to prevent medicine shortages, a 2022 report has highlighted.
European Commission approves haematology biosimilar
A marketing authorisation for a biosimilar to eculizumab has been granted by the European Commission for paroxysmal nocturnal haemoglobinuria.
Automation to guide technology shift in aseptic environments
Referencing Annex 1–2022, a paper has described how automation will be implemented in aseptic environments in view of regulatory requirements.
CHMP meeting highlights – May 2023
The Committee for Medicinal Products for Human Use (CHMP) recommended two new medicines for approval in its May meeting, including a neurosteroid for epileptic seizures.
