Sandoz granted novel biosimilars approval
The approval authorises the interchangeability of denosumab biosimilars in the US to treat primary and secondary bone loss.
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Medical device manufacturers must remain “vigilant” to ensure data integrity of premarket submissions
With the integrity of a greater number of third-party-generated data called into question, the US Food and Drug Administration (FDA) is unable to rely on the data to grant marketing authorisation, the agency asserts.
New BeiGene Head of Europe, Global Clinical Operations appointed
Bringing over two decades of experience in oncology clinical development, the biotech’s new hire will work to advocate for innovation and patient-centric clinical development for the company’s European initiatives.
New data revealed for Novartis SMA gene therapy
Novartis has revealed new data for its one-time gene therapy for spinal muscular atrophy (SMA) in older children.
New antibody drug formulation wins novel MHRA approval
A new formulation of an antibody drug has been authorised via a process from the Medicines and Healthcare products Regulatory Agency (MHRA) that enables “considerably shorter” approval timelines.
Joint investment to accelerate UK sustainable biomanufacturing
One project supported through £11.5 million investment will focus on biocatalytic nitro-reductions in scalable continuous flow reactors, using paracetamol as a case study.
NICE recommends first licenced treatment for AL amyloidosis
Having been available in Scotland and Northern Ireland since 2022, NICE’s positive opinion of the combination treatment means it is now accessible on the NHS.
Implications of AI regulation for data integrity
According to research, organisations should invest in training for those working with artificial intelligence (AI) to support data integrity assurance in AI applications.
MHRA Chief Executive to step down
During Dame June Raine’s five-year tenure as Chief Executive, MHRA delivered regulation facilitating key innovations in gene therapy and the world’s first COVID vaccine.
Amgen opens its most advanced manufacturing facility to date
The biomanufacturing facility has been designed to help Amgen meet its target of carbon neutrality in all its operations by 2027, according to the company.
Boehringer reveals major data from liver disease trial
Data suggests Boehringer Ingelheim’s novel glucagon/GLP-1 receptor dual agonist could become a best-in-class liver disease treatment for metabolic dysfunction-associated steatohepatitis (MASH).
CHMP meeting highlights: February 2024
Ten new medicines, including a new oligonucleotide therapy for ALS, were recommended for approval at the Committee for Medicinal Products for Human Use (CHMP)’s recent meeting.
AbbVie announces its new CEO
During his tenure as AbbVie’s CEO, Richard Gonzalez successfully navigated the end of exclusivity for the biologic Humira in the US.
Analysis reveals “superior efficacy” of long-acting injectable HIV treatment
The Cabenuva (cabotegravir + rilpivirine) injectable regime could benefit individuals with HIV who have challenges adhering to treatment, Phase III interim analysis suggests.
Innovation to drive advanced drug delivery market
The advanced drug delivery market is anticipated witness a compound annual growth rate (CAGR) of 4.6 percent by 2033, according to a report.
