The first-in-human trial initiated last year in healthy adults studied single and multiple doses of NaQuinate. The primary objective was to assess the safety, tolerability and pharmacokinetics. ”We The post Haoma Medica completes first-in-human trial for NaQuinate appeared first on Pharmaceutical Business review.
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With this validation, the application is complete, and the EMA will now begin the review procedure. Tepotinib is a highly selective oral MET inhibitor that is administered once The post EMA validates application for Tepotinib for treatment of advanced NSCLC with METex14 skipping alterations appeared first on Pharmaceutical Business review.
In 2019, Astellas and FibroGen have also received Japanese approval for roxadustat for the treatment of adult patients with anaemia of CKD on dialysis. FibroGen now secures a The post Astellas gets Japanese approval for Evrenzo to treat anaemia of CKD in adult patients not on dialysis appeared first on Pharmaceutical Business review.
In a communication received on November 24, 2020, the FDA reiterated that an inspection of the company’s manufacturing facility is required as part of the BLA approval process. The post FDA defers approval of DaxibotulinumtoxinA for Injection in glabellar lines due to Covid-19 related travel restrictions appeared first on Pharmaceutical Business review.
The global Phase II clinical trial is a randomised, double-blind, placebo-controlled and parallel-group trial designed to evaluate the efficacy and safety of CT-P59 in combination with standard of The post Celltrion completes enrolment for global phase II clinical trial with Covid-19 treatment candidate appeared first on Pharmaceutical Business review.
As per terms of the proposed deal, the EC can increase their purchase of Covid-19 vaccine from 80 million doses to a total of up to 160 million The post EC approves Moderna’s purchase agreement for mRNA Covid-19 vaccine appeared first on Pharmaceutical Business review.
The regulator has approved the company’s supplemental new drug application (sNDA) for Xofluza for the prevention of influenza in people aged 12 years and older following contact with The post FDA approves Roche’s Xofluza to prevent influenza following contact with infected person appeared first on Pharmaceutical Business review.
If successful, this pharmacologic approach could substantially change the treatment paradigm for OSA patients. “There is a clear unmet need for an approach that addresses the underlying cause The post Apnimed doses first patient in phase 2 trial of AD109 in obstructive sleep apnea appeared first on Pharmaceutical Business review.
Health Canada has provided a ‘No Objection Letter (NOL)’ for Appili’s proposed study; the U.S. FDA accepted a submission of a protocol amendment to conduct the trial in The post Health Canada clears Appili Therapeutics for new phase 3 trial to assess Avigan to prevent Covid-19 appeared first on Pharmaceutical Business review.
City of Hope will assess the investigational vaccine, dubbed COH04S1, in healthy volunteers aged between 18 and 55 who have not had Covid-19. The investigational vaccine is being The post City of Hope begins phase 1 clinical trial of Covid-19 vaccine candidate appeared first on Pharmaceutical Business review.
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