All articles by Catherine Eckford (European Pharmaceutical Review) – Page 55
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NewsAI-driven biosimilar manufacturing partnership announced
Artificial intelligence technology will drive manufacture of high-quality biosimilars at scale under a partnership between Sandoz and Just - Evotec Biologics.
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ArticleRecent developments in stem cell therapies
EPR explores recent developments in stem cell therapies across several hard-to-treat diseases and how technology is transforming ATMP manufacture.
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NewsRWE shows efficacy of nirsevimab for infant RSV
New real-world data “adds to the evidence that use of long-acting monoclonal antibody [nirsevimab] may prevent moderate to severe respiratory syncytial virus disease” in infants after single dose.
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NewsCould personalised mRNA vaccine be first for cancer?
Half of pancreatic ductal adenocarcinoma (PDAC) patients given a personalised mRNA neoantigen vaccine experienced delayed recurrence 18 months post-vaccination.
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News$1.7b acquisition to develop rare haematology therapy
When CTI BioPharma is acquired by Swedish Orphan Biovitrum AB (Sobi), the companies intend to advance an oral kinase inhibitor treatment for a rare haematological disease.
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NewsFDA publishes paper on AI/ML in drug development
"rapid growth in the number of submissions that reference artificial intelligence and machine learning” has prompted the US Food and Drug Administration (FDA) to seek feedback on AI/ML in drug development.
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ArticleRealising milestones with gene therapy for SMA
Novartis Gene Therapies' Vice President for Clinical Development & Analytics shares what shaped the success of one of the few commercially-available gene therapies.
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NewsSandoz to boost biosimilar development with manufacturing expansion
€25m funding is intended to unite a cutting-edge biotech lab and analytical expertise at Sandoz's German biosimilar manufacturing site.
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NewsAntibody response varies for Big Pharma COVID vaccines
Pfizer, Moderna and Johnson & Johnson COVID-19 vaccines produced varied neutralising antibody levels when assessed for short- and long-term response, says study.
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NewsCan GLP-1 obesity therapy restore NK cell function?
Irish researchers have shown that GLP-1 treatment can restore natural anti-cancer immunity via NK cells in people with obesity.
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NewsEnzyme replacement therapy approved for Fabry disease
The European Commission (EC) has given approval to the first PEGylated enzyme replacement therapy to treat Fabry disease.
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NewsMIT unlocks real-time powder particle size distribution monitoring
Massachusetts Institute of Technology researchers have developed an algorithm that extracts powder particle size distribution from laser speckle in real-time.
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NewsEMA to review CTIS transparency rules
Public consultation seeks the best methods for balancing transparency with confidentiality in the EU Clinical Trials Information System, says the European Medicines Agency.
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ArticleTransforming oncology with antibody therapeutics
Martin Vogel, Therapeutic Area Lead for Oncology, Janssen EMEA, discusses the potential of bispecific monoclonal antibodies like amivantamab to address unmet needs in advanced non-small cell lung cancer treatment.
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NewsFirst RSV vaccine approved for older adults
The US Food and Drug Administration (FDA) has approved the first-ever vaccine for respiratory syncytial virus (RSV) in adults over 60 years old.
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NewsDigital transformation to drive biomanufacturing market
According to a market report, digital transformation is becoming an essential part of biopharma manufacturing.
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NewsEuropean Commission approves CAR T therapy for lymphoma
CD19-directed CAR T-cell therapy Breyanzi has been approved by the European Commission (EC) based on significant results from a lymphoma Phase III trial.
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NewsNovel device opens blood-brain barrier to deliver chemotherapy
A novel ultrasound technique opened the blood-brain barrier to successfully deliver chemotherapy to glioblastoma patients in a first-in-human trial.
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NewsFDA releases draft guidance for decentralised clinical trials
Recommendations on the conduct of remote clinical trial visits are included in new US Food and Drug Administration (FDA) draft guidance.
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NewsAstellas to accelerate ocular disease treatments with $5.9 billion acquisition
A $5.9 billion acquisition of biotech Iveric Bio by Astellas is set to accelerate development of treatments for blinding retinal diseases.