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Details:
Efavirenz/ Emtricitabine/tenofovir disoproxil fumarate) tablets a combination of 2 nucleoside analog HIV-1 reverse transcriptase inhibitors and 1 non-nucleoside HIV-1 reverse transcriptase inhibitor, for the treatment of HIV-1 infection.
Lead Product(s): Efavirenz,Emtricitabine,Tenofovir Disproxil Fumurate
Therapeutic Area: Infections and Infectious Diseases Product Name: Atripla-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2023
Details:
Stride's Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Truvada Tablets, 200 mg/300 mg, of Gilead Sciences.
Lead Product(s): Emtricitabine,Tenofovir Disoproxil Fumarate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 15, 2021
Details:
Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) is a USFDA approved fixed dose combination. It is being evaluated for the treatment of HIV and Hepatitis B.
Lead Product(s): Bictegravir,Emtricitabine,Tenofovir Alafenamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Biktarvy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 06, 2024
Details:
Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) is a USFDA approved fixed dose combination. It got extended approval for the treatment of HIV with suppressed viral loads, pre-existing resistance.
Lead Product(s): Bictegravir,Emtricitabine,Tenofovir Alafenamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Biktarvy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2024
Details:
The partnership aims to accelerate the development of an investigational dispersible pediatric formulation containing Descovy (emtricitabine) and tenofovir alafenamide (F/TAF).
Lead Product(s): Emtricitabine,Tenofovir Alafenamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Descovy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: CHAI
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership July 13, 2023
Details:
Biktarvy is a combination of bictegravir which targets HIV-1 integrase thus inhibiting HIV virus replication, emtricitabine and tenofovir alafenamide which inhibits the activity of the HIV-1 reverse transcriptase resulting in DNA chain termination.
Lead Product(s): Bictegravir,Emtricitabine,Tenofovir Alafenamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Biktarvy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2023
Details:
The combination inhibits HIV-1 replication, in which dolutegravir inhibits HIV integrase and blocks the strand transfer step of retroviral DNA integration where emtricitabine and tenofovir alafenamide inhibits the activity of the HIV-1 reverse transcriptase.
Lead Product(s): Dolutegravir Sodium,Emtricitabine,Tenofovir Alafenamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Dolutegravir/Emtricitabine/Tenofovir Alafenamide-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 31, 2023
Details:
Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available.
Lead Product(s): Bictegravir,Emtricitabine,Tenofovir Alafenamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Biktarvy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 29, 2022
Details:
Biktarvy (bictegravir) is HIV treatment that combines three powerful medicines to form smallest 3-drug, INSTI-based single-tablet regimen available, offering simple once-daily dosing with or without food, with limited drug interaction potential and high barrier to resistance.
Lead Product(s): Bictegravir,Emtricitabine,Tenofovir Alafenamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Biktarvy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 24, 2022
Details:
Data from ALLIANCE trial evaluating Biktarvy (bictegravir) versus dolutegravir 50 mg (DTG) + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, demonstrated the efficacy of both antiretroviral regimens, in adults with HIV/HBV co-infection initiating treatment.
Lead Product(s): Bictegravir,Emtricitabine,Tenofovir Alafenamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Biktarvy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2022
Details:
Five-year cumulative outcomes, Biktarvy (bictegravir, emtricitabine, tenofovir, alafenamide) in treatment-naïve people living with HIV, high barrier to resistance, durability, efficacy, and safety in people with HIV who initiated treatment with single-tablet regimen.
Lead Product(s): Bictegravir,Emtricitabine,Tenofovir Alafenamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Biktarvy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 21, 2022
Details:
Biktarvy is a complete HIV-1 treatment that combines three powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food.
Lead Product(s): Bictegravir,Emtricitabine,Tenofovir Alafenamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Biktarvy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 11, 2022
Details:
Gilead will present the Phase 3 PINETREE data investigating a three-day course of Veklury (remdesivir), which targets viral RNA polymerase, IV treatment for non-hospitalized patients with mild-to-moderate COVID-19 at high risk of disease progression.
Lead Product(s): Bictegravir,Emtricitabine,Tenofovir Alafenamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Biktarvy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 08, 2022
Details:
ViiV Healthcare, GSK and Shionogi alleged that Gilead’s Biktarvy, a triple combination HIV medicine containing the HIV integrase inhibitor bictegravir, tenofovir alafenamide and emtricitabine, infringed certain of their patents relating to dolutegravir.
Lead Product(s): Bictegravir,Emtricitabine,Tenofovir Alafenamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Biktarvy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Gilead Sciences
Deal Size: Undisclosed Upfront Cash: $1,250.0 million
Deal Type: Licensing Agreement February 01, 2022
Details:
BICSTaR study is designed to evaluate antiviral effectiveness and safety profile of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg ) met specific treatment needs of diverse groups of people, including men and women aging with HIV.
Lead Product(s): Bictegravir,Emtricitabine,Tenofovir Alafenamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Biktarvy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 29, 2021
Details:
Biktarvy is a complete HIV-1 treatment that combines 3 powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available.
Lead Product(s): Bictegravir,Emtricitabine,Tenofovir Alafenamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Biktarvy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2021
Details:
The use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational, and the safety and efficacy of Biktarvy for this use have not been established.
Lead Product(s): Bictegravir,Emtricitabine,Tenofovir Alafenamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Biktarvy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 12, 2021
Details:
Lupin has received approval from the United States Food and Drug Administration (USFDA) to market its Emtricitabine and Tenofovir Disoproxil Fumarate tablets, 200 mg/300 mg. The drugs are indicated in combination with other antiretroviral agents for HIV-1 infection.
Lead Product(s): Emtricitabine,Tenofovir Disoproxil Fumarate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 2021
Details:
More than 98% of treatment-naïve patients achieved and maintained undetectable viral load with Biktarvy through four years in the open-label extension phase of two phase 3 studies.
Lead Product(s): Bictegravir,Emtricitabine,Tenofovir Alafenamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Biktarvy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 06, 2021
Details:
The breakthrough therapy designation is based on efficacy and safety results from HPTN 083, a phase IIb/III clinical trial that compared long-acting, injectable cabotegravir to daily oral emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg for HIV prevention.
Lead Product(s): Cabotegravir,Tenofovir Disoproxil Fumarate,Emtricitabine
Therapeutic Area: Infections and Infectious Diseases Product Name: Vocabria
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2020
Details:
Interim analysis from HPTN 084 study shows long-acting injectable cabotegravir administered every two months is 89% more effective than daily pills in preventing HIV acquisition in women.
Lead Product(s): Cabotegravir,Tenofovir Disoproxil Fumarate,Emtricitabine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Institute of Allergy and Infectious Diseases
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
Details:
Emtricitabine and Tenofovir Disoproxil Fumarate Tablets and Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are both combination treatments available as a single pill with similar safety profiles to their reference products.
Lead Product(s): Emtricitabine,Tenofovir Disoproxil Fumarate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 02, 2020
Details:
Presentations will highlight new switch data for Biktarvy, as well as real-world findings and patient-reported outcomes from a treatment perspective, and new data on Gilead's first-in-class investigational long-acting injectable lenacapavir.
Lead Product(s): Lenacapavir,Emtricitabine,Tenofovir Alafenamide
Therapeutic Area: Infections and Infectious Diseases Product Name: GS-6207
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2020
Details:
China National Medical Products Administration (NMPA) has approved a pre-exposure prophylaxis indication for Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg,FTC/TDF).
Lead Product(s): Emtricitabine,Tenofovir Disoproxil Fumarate
Therapeutic Area: Infections and Infectious Diseases Product Name: Truvada
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2020
Details:
Janssen has no clinical nor pharmacological evidence to support the inclusion of DRV/cobicistat in treatment guidelines for COVID-19.
Lead Product(s): Darunavir,Cobicistat,Emtricitabine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2020
Details:
The trial demonstrating continued non-inferior efficacy and continued favorable changes in key markers of renal and bone safety at Week 96 compared with Truvada for PrEP.
Lead Product(s): Emtricitabine,Tenofovir Alafenamide,Bictegravir
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 10, 2020
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