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Lead Product(s): Dolutegravir
Therapeutic Area: Infections and Infectious Diseases Product Name: Tivicay
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 13, 2021
Details:
The authorisation includes updated dosing recommendations, for Tivicay (dolutegravir) film-coated tablets (10mg, 25mg and 50mg) for children 6 years and older and weighing at least 14kg, bringing these in line with the World Health Organization weight bands.
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Lead Product(s): ChAdOx1 nCoV-19
Therapeutic Area: Infections and Infectious Diseases Product Name: AZD1222
Highest Development Status: Approved Product Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 30, 2020
Details:
So far, some evidence has been assessed on safety and efficacy coming from a pooled analysis of interim clinical data from four ongoing clinical trials in the UK, Brazil and South Africa.
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Lead Product(s): ChAdOx1 nCoV-19
Therapeutic Area: Infections and Infectious Diseases Product Name: AZD1222
Highest Development Status: Approved Product Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 30, 2020
Details:
The authorisation recommends two doses administered in four and 12 weeks interval. This regimen was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose.
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Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Vocabria
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Janssen Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2020
Details:
Marketing Authorisation granted by European Commission for ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) to be used with Janssen’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets).
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Lead Product(s): Tafenoquine Succinate
Therapeutic Area: Infections and Infectious Diseases Product Name: Krintafel
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 2020
Details:
Data from the TEACH study of tafenoquine, an 8-aminoquinoline, for the prevention of relapse of Plasmodium vivax (P. vivax) malaria in children and adolescents showed 95% of the study’s 60 subjects had no recurrence of P. vivax malaria during four months of follow-up.
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Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: COVID-19 Therapeutics Accelerator
Deal Size: $0.5 million Upfront Cash: Undisclosed
Deal Type: Funding November 17, 2020
Details:
This funding supports efforts to combat the COVID-19 pandemic through the rapid process development and manufacturing of remdesivir.
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Lead Product(s): Dolutegravir,Lamivudine
Therapeutic Area: Infections and Infectious Diseases Product Name: Dovato
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 2020
Details:
Dovato allows adults living with HIV to reduce the number of antiretroviral therapies they take each day, while maintaining efficacy and high barrier to resistance comparable to tenofovir-based regimens of at least three drugs.
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Lead Product(s): Fostemsavir,Undisclosed
Therapeutic Area: Infections and Infectious Diseases Product Name: Rukobia
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 02, 2020
Details:
In a phase III study, a majority (60%) of heavily treatment-experienced adults randomized to receive Rukobia with an optimized background therapy achieved and maintained viral suppression through 96 weeks, addressing a critical unmet need.
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Lead Product(s): Cabotegravir,Rilpivirine
Therapeutic Area: Infections and Infectious Diseases Product Name: Cabenuva
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 02, 2020
Details:
Comapany to present the final efficacy analysis from the global HPTN 083 study evaluating cabotegravir for HIV prevention.
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Lead Product(s): Dolutegravir
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
Details:
U.S FDA has approved Tivicay PD (dolutegravir) tablets for oral suspension, which are used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in paediatric patients.
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