FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert
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            Lead Product(s): Favipiravir,Colchicine

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 08, 2020

            Details:

            Study will combine and repurpose antivirals and host-directed therapies and to determine safety & efficacy of a combination of drugs (Favipiravir+Colchicine, Umifenovir+Colchicine and Nafamostat+5-ALA) and a control arm with the standard of care in COVID-19 patients.

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            Lead Product(s): VPM1002

            Therapeutic Area: Infections and Infectious Diseases Product Name: VPM1002

            Highest Development Status: Phase III Product Type: Vaccine

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 18, 2020

            Details:

            SII is currently working on three candidates for COVID-19, including the testing of its recombinant-BCG vaccine in Phase 3 clinical trials at several locations across India.

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            Lead Product(s): Urinastatin

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 09, 2020

            Details:

            The trial will involve approximately 120 patients who have mild to moderate symptoms of acute ARDS. The drug is expected to improve recovery time and also mitigate mortality rates.

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            Lead Product(s): Favipiravir,Umifenovir

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 26, 2020

            Details:

            Early treatment with combination therapy will be evaluated for safety and efficacy as it is emerging as an effective approach in shortening duration of virus shedding, decreasing cytokine response, and facilitating early discharge of patients.

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            Lead Product(s): Nitazoxanide

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 25, 2020

            Details:

            Novalead will study the effectiveness of an anti- parasitic drug in the recovery of moderately ill Covid-19 patients. Novalead is enrolling 100 patients across six centres for the trial which is expected to start in a month’s time.

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            Lead Product(s): NLP21

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 21, 2020

            Details:

            According to the company, NLP21 shows promising ability to act on COVID-19 through multiple relevant targets which enables its not only to prevent virus binding to the human cells but also clear damaged human cells to allow regeneration of healthier cells.

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            Lead Product(s): Mycobacterium w

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Vaccine

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 16, 2020

            Details:

            The trials of the drug Mycobacterium W (Mw) were conducted on COVID-19 patients at AIIMS Bhopal for the last few days. If Mycobacterium W proves effective during the clinical trial, it will be used in the treatment of COVID-19.

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            Lead Product(s): Remdesivir

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Gilead Sciences

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement May 13, 2020

            Details:

            The agreements allow the companies – Cipla, Ferozsons Laboratories, Hetero Labs, Jubilant Lifesciences and Mylan – to manufacture remdesivir for distribution in 127 countries.

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            Lead Product(s): Tocilizumab

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 12, 2020

            Details:

            Tocilizumab has been tested on 6 patients admitted at Seven Hills Hospital and 4 patients in Kasturba Hospital, both COVID-19 centres in Mumbai.

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            Lead Product(s): Secnidazole

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 04, 2020

            Details:

            Phase 3 Study of Single-Dose Solosec® demonstrated a clinically and statistically significant response rate, or microbiological cure, in patients dosed with Solosec® as compared to placebo.