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FDA awards 11 grants for rare disease treatment developments
The FDA has awarded 11 grants equating to about $25 million of funding to clinical trials for the development of rare disease treatments.
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Clinical Development
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EFPIA calls for harmonisation of GMO procedures in investigational drugs
The European Federation of Pharmaceutical Industries will implement a new regulation to co-ordinate genetically modified organism procedures.
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Manganese a promising new catalyst for drug synthesis
Researchers have found that manganese can simplify the process of synthesising fluoroketones for drug design and manufacture.
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Indian active pharmaceutical ingredients market to grow by 12.24 percent
The Indian active pharmaceutical ingredients (APIs) market stood at $11.8 billion in 2021 and continues to grow, says market report.
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Radionuclide therapy a promising option to treat HER2 breast cancer
The radionuclide treatment combines radioactive iodine therapy with single-domain antibodies to target the HER2 antigen.
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AstraZeneca to collaborate with VaxEquity on RNA therapeutics
AstraZeneca will partner with VaxEquity for the discovery and development of a self-amplifying RNA (saRNA) therapeutics platform.
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Immuno-bridging studies are sufficient for authorising new COVID-19 vaccines, say regulators
The Access Consortium, comprising regulators from the UK, Australia, Canada, Singapore and Switzerland, announce that immuno-bridging studies can be used to support COVID-19 vaccine authorisation.
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Neoadjuvant atezolizumab combination meets safety criteria in pleural mesothelioma
Neoadjuvant cisplatin and pemetrexed in combination with atezolizumab met safety criteria in resectable pleural mesothelioma clinical study.
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Imfinzi™ and tremelimumab combo improves NSCLC outcomes
Imfinizi™ and tremelimumab in combination with chemotherapy improved non-small lung cancer (NSCLC) survival by 23 percent in a Phase III study.
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Lumakras™ (sotorasib) helps control brain metastases
Amgen’s Lumakras™, a KRAS inhibitor, was found to improve the stability of brain metastases in a Phase II study.
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Embedding inclusion in pharmaceutical design
In this article, Included’s Raafi-Karim Alidina explores biases in product design, outlining how they impact pharmaceuticals as well as technologies, and practical steps to enhance diversity and ensure inclusion.
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Roche to acquire TIB Molbiol Group to expand PCR-test portfolio
Roche signs a definitive share purchase agreement with TIB Molbiol Group to expand PCR-test portfolio against infectious diseases.
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Moderna and ILCM to develop Crigler-Najjar syndrome therapeutic
Moderna and the Institute for Life Changing Medicines (ILCM) are collaborating to develop an mRNA therapeutic for Crigler-Najjar syndrome.
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Phase III clinical trial for respiratory syncytial virus (RSV) vaccine begins
Pfizer’s RENOIR Phase III trial will evaluate the efficacy, immunogenicity and safety of their respiratory syncytial virus (RSV) vaccine.
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Fostamatinib reduces COVID-19 risks by 50 percent in Phase II study
Fostamatinib significantly reduced serious adverse effects and risk of death in hospitalised COVID-19 patients, shows Phase II study.