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  • in Health care

    Akums gets CDSCO Panel nod for Phase III CT of FDC Moxifloxacin, Nepafenac ophthalmic solution

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    New Delhi: The drug major Akum Pharmaceutical has got the green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the Phase III clinical trial study of the fixed-dose combination of Moxifloxacin plus Nepafenac ophthalmic solution. This came after the firm presented the revised Phase III […] More

  • in Health care

    Revise Phase III CT protocol: CDSCO Panel Tells Dr Reddy’s over Tegoprazan

    Revise Phase III CT protocol: CDSCO Panel Tells Dr Reddy's over Tegoprazan

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    New Delhi: In response to the proposal to conduct a Phase III clinical trial presented by the drug major Reddy’s Laboratories, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the firm to revise the protocol of Phase III clinical trial of the drug Tegoprazan with respect to the […] More

  • in Health care

    CDSCO panel approves Reliance Life Science’s Phase III CT Protocol for Tocilizumab

    CDSCO panel approves Reliance Life Science's Phase III CT Protocol for Tocilizumab

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    New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved Reliance Life Science’s Phase III clinical trial protocol of immunosuppressive Tocilizumab with some changes in exclusion criteria. This came after the firm presented the proposal to conduct a Phase III clinical trial titled “A prospective, multicenter, randomized, […] More

  • in Health care

    Conduct PK study for repeated dose and Phase III CT : CDSCO Panel tells Sun Pharma on Psoriatic drug combination

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    New Delhi: Rejecting the drug major Sun Pharma’s proposal for a Phase III clinical trial study waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined that the firm should conduct the pharmacokinetic (PK) study for repeated dose and the Phase III clinical trial of the fixed-dose combination […] More

  • in Health care

    Novartis gets CDSCO panel nod for Phase III CT of anticancer drug Ianalumab

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    New Delhi: In a significant development, pharmaceutical major Novartis has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III clinical trial of anticancer drug Ianalumab (VAY736). However, this approval is subject to the condition that the applicant submit safety data on […] More

  • in Health care

    GSK declares positive pivotal phase III data for 5-in-1 Meningococcal ABCWY vaccine

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    London: GSK plc has announced positive headline results from the phase III trial (NCT04502693) evaluating the safety, tolerability, and immunogenicity of its MenABCWY combination vaccine candidate, administered as two doses given six months apart in healthy individuals aged 10-25 years. GSK’s MenABCWY vaccine candidate combines the antigenic components of its licensed meningococcal vaccines, Bexsero (MenB) […] More