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Regulators recommend remote inspections for use post-pandemic
A review of remote regulatory inspections has recommended that they be used in conjunction with on-site visits to enable GxP oversight post-pandemic.
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Clinical Development
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EMA initiates rolling review of Valneva’s COVID-19 vaccine (VLA2001)
The European Medicines Agency (EMA)'s human medicines agency (CHMP) begins a rolling review of Valneva's COVID-19 vaccine VLA2001 following positive preliminary results.
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Drug repurposing pilot to support not-for-profit organisations and academia
The European Medicines Agency (EMA)'s pilot project will support not-for-profit organisations and academia in gathering evidence for the use of a drug in a new indication.
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Stelara® shows promise to treat gut diseases in new analyses
Two new analyses displayed positive data supporting Stelara for the treatment of Crohn's disease and ulcerative colitis.
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CHMP initiates rolling review of molnupiravir for COVID-19
The European Medicines Agency's human medicines committee (CHMP) begins its rolling review of the investigational oral antiviral molnupiravir.
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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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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.
