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    Glenmark Gets CDSCO panel nod for Phase IV CT of COPD drug

    New Delhi: Pharmaceutical major, Glenmark has got the green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV clinical trial of the fixed dose combination (FDC) Glycopyrrolate plus Budesonide plus Formoterol Fumarate dihydrate actuation delivers inhalation aerosol. However, this approval is subjected to […] More

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

    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

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    Revise Phase I/II CT protocol: CDSCO panel tells Serum Institute of India on Dengue Tetravalent Vaccine

    Revise Phase I/II CT protocol: CDSCO panel tells Serum Institute of India on Dengue Tetravalent Vaccine

    New Delhi: Regarding the Phase I/II clinical trial of Dengue Tetravalent Vaccine (Live, Attenuated), the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the vaccine major Serum Institute of India to revise the Phase I/II clinical trial protocol. This came after the firm presented its proposal to conduct of […] More

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    J&J Gets CDSCO Panel Nod To Conduct Phase IV CT of Ustekinumab

    J&J Gets CDSCO Panel Nod To Conduct Phase IV CT of Ustekinumab

    New Delhi: In order to evaluate safety of Ustekinumab in Indian subjects with Crohn’s Disease (CD), pharmaceutical major, Johnson & Johnson has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV trial of Ustekinumab Pre-filled syringes 45 mg/0.5 ml, 90 mg/ml […] More

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    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

    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

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    Revise Phase IV CT Protocol: CDSCO panel tells Zydus Lifesciences on Typhoid Vi Conjugate Vaccine with Yellow Fever Vaccine

    Revise Phase IV CT Protocol: CDSCO panel tells Zydus Lifesciences on Typhoid Vi Conjugate Vaccine with Yellow Fever Vaccine

    New Delhi: In response to the drug major Zydus Life Sciences’ proposal to conduct Phase IV clinical for Typhoid Vi Conjugate Vaccine I.P.(TCV) with Yellow Fever Vaccine(YFV), the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the firm to revise the Phase IV clinical trial protocol. This came after […] More

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    Lupin Gets CDSCO Panel Nod for Phase IV CT of pulmonary FDC drug

    Lupin Gets CDSCO Panel Nod for Phase IV CT of pulmonary FDC drug

    New Delhi: Pharmaceutical major, Lupin has got the go ahead from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) to conduct a Phase IV clinical trial of the fixed-dose combination Mometasone furoate plus Glycopyrronium bromide plus Indacaterol acetate Inhalation Powder This came after the firm presented the Phase IV clinical […] More

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    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

    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

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    Priyanka Chopra On Why She Spoke About Being ”Cornered” In Bollywood Years Later: ”Confident Enough To Talk About That Phase”

    Global star Priyanka Chopra does not hold any grudges against people in Bollywood who “cornered” her in the past. Priyanka recently made headlines with her explosive interview against Bollywood. In an international podcast, she opened up about how some people pushed her into a corner, eventually leading to her exit from Bollywood. However, she did […] More

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

    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

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    Syngene Proposal To Conduct Phase I CT of Ferumoxytol Inj rejected by CDSCO panel

    New Delhi: Stating that the proposal submitted by Syngene International could not be considered at present, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has rejected the proposal to conduct the Phase I clinical trial of Ferumoxytol injection. The drug to be used in the proposed trial is not […] More

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