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Review: Good identification practices for organic extractables and leachables via mass spectrometry
The function of a pharmaceutical drug product or a medical device is to provide the patient with a desired therapeutic benefit.
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Therapeutics
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MHRA approves Epidyolex® (cannabidiol) for TSC seizure treatment
GW Pharmaceuticals received approval for Epidyolex®(cannabidiol) for the treatment of seizures linked to tuberous sclerosis complex (TSC) in the UK.
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Dissolvable microneedle patch may be the answer to baldness
A newly developed investigational microneedle patch caused mice to regrow hair faster than minoxidil, a leading alopecia treatment.
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Monoclonal antibody prevents malaria in small NIH trial
One dose of a monoclonal antibody developed at the US National Institutes of Health (NIH) prevented malaria for up to nine months.
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BMS initiates Tomorrow’s Innovators scheme to promote diversity in biopharma
Bristol Myers Squibb (BMS)’s Tomorrow’s Innovators programme will promote the recruitment of Black talent into the biopharma industry.
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Cell and gene therapy manufacturing services market to value $13.8 billion by 2026
The global cell and gene therapy manufacturing services market is expected to grow at a CAGR of 12.4 percent in the next five years.
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Parkinson’s disease market sales to reach $11.5 billion in 2029
The Parkinson’s disease market is set to triple in sales by 2029 driven by novel biologics and delivery systems, reports GlobalData.
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Enhertu improves survival in Phase III breast cancer trial
Enhertu (trastuzumab deruxtecan) significantly improved survival in the DESTINY-Breast03 Phase III head-to-head trial against trastuzumab emtansine.
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FDA releases guidance for near infrared (NIR) analytical procedures
New final guidance will aid drug developers in developing, validating, applying and submitting near infrared (NIR) spectroscopy-based analytical procedures.
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Cell line development services market to value $2.4 billion by 2030
New report suggests the cell line development services market will witness a 14.3 percent CAGR between 2021 and 2030.
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Forxiga approved in EU for chronic kidney disease treatment
Forxiga’s approval, based on unprecedented Phase III data, is the most significant advancement in chronic kidney disease (CKD) treatment in over 20 years.
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Libtayo® with chemotherapy trial stopped early due to success
Phase III trial of Libtayo® (cemiplimab) combined with chemotherapy stops early due to significant improvement in overall survival in lung cancer patients.
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Collaboration and integration to progress clinical research
Here, Lucinda Cash-Gibson and Francesco Patalano discuss why the pharmaceutical industry is collaborating to develop protocols for patient-centric integrated platform trials and what the clinical research industry may look like in future.
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Global API CDMO market to value almost $140bn by 2028
Market research suggests the Asia Pacific region could soon overtake Europe and North America in the active pharmaceutical ingredient (API) contract development and manufacturing organisation (CDMO) market.
