Guidance recommending BMS cardiac myosin inhibitor published
NICE’s final guidance recommending Bristol Myers Squibb’s first-in-class obstructive hypertrophic cardiomyopathy (oHCM) drug on the NHS, is now published.
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Raman spectroscopy market expected to value $875m by 2028
A report has shown that growing demand for accurate identification of pharmaceutical raw materials is anticipated to boost the global Raman spectroscopy market.
Semaglutide weight loss injection launched in UK
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.
New medicines manufacturing centre to enhance UK talent
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.
Miniaturised PAT tool demonstrates real-time aggregation measurement
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.
NICE recommends new Fabry disease treatment
Recommendation of Elfabrio® (pegunigalsidase alfa) means patients with Fabry disease in England will be able to access a new treatment option.
FTC order could ease biopharma competition
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.
Trial-first for Roche lung cancer ALK inhibitor
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.
$2 billion mRNA-based oncology therapy market anticipated by 2029
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.
IMA: the all-in-one solutions provider for complete vaccines lines
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.
CHMP recommends updated Omicron vaccine
Pfizer and BioNTech’s adapted Omicron XBB.1.5 COVID-19 vaccine has been recommended for two additional indications in the EU.
Stem cell therapy delivers potential for sickle cell disease
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.
CGT manufacturing QC market to value $2.8b by 2031
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.
Guidance for medicine packaging under Windsor Framework
The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance to support implementation of new requirements for medicine packaging in 2025 under the Windsor Framework.
European regulatory perspective on nitrosamine mitigation strategies
With nitrite concentration in excipients being a key risk factor in nitrosamine drug substance related impurities (NDSRI) formation, there is opportunity to implement corrective and preventative actions (CAPAs), EMA experts say.
