FDA approval could shape liver disease treatment landscape
A novel liver therapy authorised under US Food and Drug Administration (FDA) Accelerated Approval, is a potential game-changer in the NASH treatment space.
List view / Grid view
News
Innovative method could offer cost-effective sterilisation approach
The new sterilisation method could provide an affordable, rapid approach for preparing microbiological culture media, research suggests.
Boehringer collaboration could advance first-in-class schizophrenia treatments
A new global collaboration and exclusive option-to-license agreement between Boehringer Ingelheim and Sosei Group Corporation includes a novel precision treatment for schizophrenia.
Manufacturing facility expansion to advance next-gen vaccine
The first South Korean vaccine manufacturing facility to achieve EU-GMP certification from the European Medicines Agency (EMA) is being expanded to support global supply of a pneumococcal conjugate vaccine.
Rapid pseudomonas aeruginosa detection method developed
Research suggests the rapid detection method “will enable the timely implementation of microbiological monitoring strategies for large batches of medications”.
J&J reveal long-term data for novel oral peptide
The new data suggests the IL-23 receptor antagonist peptide has potential to address the high unmet need of a durable and convenient oral option in moderate-to-severe plaque psoriasis.
FDA warning letters highlight data integrity issues
Recent FDA Warning Letters have identified three manufacturers whose facilities held data integrity violations related to microbiology and environmental monitoring.
Inlet air conveyor optimisation in a continuous tablet coater
An inlet conveyor with a linear diffuser inside a continuous tablet coater offers better air flow distribution for tablet drying, research by IMA Pharma suggests.
Manufacturer retracts acquisition deal due to “data integrity issues”
According to Olympus Corporation, concerns about the non-vascular metallic stents were found post-closing following the agreed acquisition of Taewoong Medical Co., Ltd.
Preventing fungal contamination in pharmaceuticals
While fungal contamination detection in pharmaceutical manufacturing remains a challenge, preventive practices and policies must be followed, research states.
Semaglutide could provide novel dual benefit in diabetes and kidney disease
The new data suggests Novo Nordisk’s small molecule treatment semaglutide could become the first GLP-1 treatment option for patients with type 2 diabetes and chronic kidney disease (CKD).
The role of GAMP 5, data integrity and QbD in pharmaceutical quality assurance
By ensuring accurate and reliable data in drug development, data integrity supports regulatory compliance and drug safety, a paper explains.
Employing MALDI-TOF MS for microbial identification in sterile drug manufacturing
A study investigating microbial risks of the entire manufacturing process has identified MALDI-TOF MS as a promising first-line tool for pharmaceutical environmental monitoring.
UK manufacturing and R&D to benefit from new £360m investment
A joint government and industry investment of £92 million intended to expand UK medicine manufacturing facilities, form part of a new £360 million funding package from the UK government.
New radiopharmaceutical laboratory opens in Germany
Ariceum Therapeutics’ new Berlin-based laboratory gives the company internal capability to progress the development of its lead radiopharmaceutical candidates.
