Full data set for new buffer stock blending system freely available
NIIMBL and BioPhorum reveal open-access design models for a new buffer stock blending system that could help reduce bottlenecks in biomanufacturing plants.
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First oral combined estetrol contraceptive available in UK
The first oral contraceptive tablet using a combination of estetrol (E4) and drospirenone (DRSP) is available in the UK.
Lilly will acquire Akouos to accelerate hearing loss therapies
Eli Lilly and Company’s $610 million acquisition of Akouos will fast-track gene therapies that restore, improve and preserve hearing for patients worldwide.
$38 million will fund rare disease research over four-year period
Research for rare diseases including ALS will be supported over the next four years by $38 million in FDA funding.
Evaluating benefits of outsourcing biopharma R&D
Near-term gains from outsourcing biopharma R&D activities can be offset by slower innovation in the long run, according to a recent paper.
EC approves CAR T-Cell therapy for B-cell lymphoma
Yescarta approved by EC for the treatment of large B-Cell lypmphoma and high grade B-cell lymphoma.
£12 million given to Sheffield Biomedical Research Centre
The UK’s Sheffield Biomedical Research Centre has been awarded £12 million to help accelerate R&D of vaccines and treat conditions like HIV.
HPAPI contract manufacturing to value $14.6 billion by 2030
Rising demand for cancer drugs, combined with high in-house manufacturing costs is driving growth in the high-potency API outsourcing market.
CHMP recommends dengue vaccine for children
Takeda’s novel dengue vaccine has received positive opinion from the EMA’s human medicines committee (CHMP), demonstrating the vaccine is safe for patients from four years old.
Sanofi to sell Japanese manufacturing plant
Sanofi’s Japan-based manufacturing site near Tokyo will be sold to a European contract development and manufacturing organisation.
CHMP recommends Pluvicto® for treating advanced prostate cancer
CHMP issues positive opinion on Pluvicto®, paving the way for it to become the first European-approved radioligand therapy for metastatic prostate cancer patients.
Enterin and Parkinson’s UK to partner on dementia study
A new Phase II trial will study the drug ENT-01 for Parkinson’s Disease (PD)-associated dementia at sites in the UK and US.
RemeGen receives ODD for myasthenia gravis treatment
The FDA has granted ODD to Telitacicept, produced by RemeGen, for the treatment of myasthenia gravis.
Biosimilar competition saves US healthcare $21 billion
The US biosimilars market experienced dramatic growth in 2022, particularly for therapies helping to treat oncological and inflammatory conditions, Amgen suggested in a recent report.
Astellas reports effectiveness of potential treatment for VMS
Results from a clinical study by Astellas have demonstrated the effectiveness of fezolinetant as a treatment for menopause-associated VMS.
