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FDA Grants Orphan Drug Designation to NS-089/NCNP-02 for the Treatment of Duchenne Muscular Dystrophy
NS-089/NCNP-02 previously received Rare Pediatric Disease Designation from the FDA in June 2023 and Breakthrough Therapy Designation in July 2023
FDA approves Iveric Bio’s Izervay for geographic atrophy treatment
The FDA granted approval based on the results of the GATHER1 and GATHER2 Phase 3 clinical trials in which Izervay met the primary endpoint and reduced the rate of GA growth
GSK’s Arexvy gets Health Canada approval for LRTD in older adults
The approval was based on the overall Phase 3 trial in which Arexvy showed a high vaccine efficacy of 82.6% for LRTD prevention and 94.6% efficacy in those with underlying medical conditions
Lilly’s Retevmo meets primary endpoint in Phase 3 NSCLC study
In the trial, the RET kinase inhibitor showed a clinically meaningful and statistically significant improvement in progression-free survival as per a pre-specified interim efficacy analysis carried out by IDMC
ACCORD and HIPRA Enter into Exclusive Distribution Agreement to Commercialise HIPRA’s COVID-19 vaccine in UK
BIMERVAX: A booster dose of bivalent recombinant protein vaccine provides immunisation in people over 16 years of age
Saudi Fund for Development Signs a USD $75m Loan Agreement in Saint Lucia to Reconstruct and Rehabilitate St. Jude Hospital
SFD’s development loan will help to provide an integrated medical facility offering secondary medical care to Saint Lucia’s population, with a capacity of approximately 100 beds
Merck’s Ervebo Ebola vaccine gets FDA expanded approval for young children
ERVEBO is a live recombinant viral vaccine that includes a vesicular stomatitis virus backbone deleted for the VSV envelope glycoprotein and replaced with the envelope glycoprotein of the Zaire ebolavirus
Bavarian Nordic secures $120m US BARDA contract for vaccine production
The bulk product, worth $96m, will be made and invoiced in 2023, but it will only partially replenish the inventory that was utilised to manufacture vaccinations in response to the mpox outbreak in 2022
Cognizant, Google Cloud to develop healthcare large language model solutions
The programme, which combines Google Cloud’s Vertex AI platform with Cognizant’s AI domain expertise and healthcare industry knowledge, processes and experience, will initially focus on transforming administrative processes
FDA approves Lonsurf/ bevacizumab combination for mCRC treatment
The approval is based on the results of the Phase 3 SUNLIGHT trial in which the combination of Lonsurf and bevacizumab significantly and clinically meaningfully improved OS and PFS in mCRC patients