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Details:
The drug Olumiant (baricitinib) has received restricted emergency use approval from the Central Drugs Standard Control Organization (CDSCO), for use in combination with remdesivir for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults.
Lead Product(s): Baricitinib,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Olumiant
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 11, 2021
Details:
The launch is part of the licensing agreement with Gilead Sciences, that grants Dr. Reddy’s the right to register, manufacture and sell Remdesivir (Redyx), a potential treatment for Covid-19, in 127 countries including India.
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Redyx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Gilead Sciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 09, 2020
Details:
Dr. Reddy’s will receive technology transfer from Gilead for manufacturing of this Remdesivir. Dr. Reddy’s would need to do the manufacturing scale up and obtain regulatory approval for marketing of this drug in respective countries.
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Gilead Sciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement June 13, 2020
Details:
RHB-107 (Upamostat) is a serine protease inhibitor small molecule drug candidate, which is currently being evaluated in combination with remdesivir for the treatment of Ebola.
Lead Product(s): Upamostat,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-107
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 20, 2023
Details:
Veklury (remdesivir) is an adenosine nucleotide prodrug, it inhibits SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), which is investigated for the treatment of COVID-19 in people With Hepatic Impairment.
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury
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 September 19, 2023
Details:
Veklury (remdesivir) is an adenosine nucleotide prodrug, it inhibits SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), which is essential for viral replication.
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury
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 24, 2023
Details:
Veklury (remdesivir) is an adenosine nucleotide prodrug, it inhibits SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), which is essential for viral replication.
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury
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 14, 2023
Details:
Veklury (remdesivir) is an adenosine nucleotide prodrug, it inhibits SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), which is essential for viral replication.
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 25, 2023
Details:
Veklury (remdesivir) is an adenosine nucleotide prodrug, it inhibits SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), which is essential for viral replication.
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2023
Details:
Veklury (remdesivir) is an adenosine nucleotide prodrug, it inhibits SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), which is essential for viral replication.
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury
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 21, 2023
Details:
Veklury (remdesivir) directly inhibits viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase. Of the 53 pediatric patients enrolled in the CARAVAN study, no new safety signals were apparent for patients treated with Veklury.
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2022
Details:
Veklury (remdesivir) use in treatment of COVID-19 is driven by final results of SOLIDARITY study, which showed a significant 17% lower relative risk of death or progression to needing ventilation in patients requiring supplemental oxygen at baseline, compared to soc.
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2022
Details:
To minimize potential toxicity a relatively low oral dose of 5 mg/kg/day for a duration of 5 days was selected to be administered to patients randomized into the CSA (cyclosporine) arm.
Lead Product(s): Cyclosporine,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: CsA
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 08, 2022
Details:
Veklury (remdesivir) is a nucleotide analog for the treatment of COVID-19 in adults and adolescents with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of treatment).
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury
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 22, 2022
Details:
The agreement covers purchases of Veklury (remdesivir) over the next twelve months and has the option to be extended for an additional six months. It follows the expiration of the original JPA agreement, the first for a COVID-19 therapeutic, signed in October 2020.
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: European Commission
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 19, 2022
Details:
Humaneered (lenzilumab) is a first-in class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF), as a treatment for cytokine storm associated with CD19- targeted CAR-T cell therapies.
Lead Product(s): Lenzilumab,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Humaneered
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 12, 2022
Details:
Under the agreement, PCI will purchase Humaneered (lenzilumab), for resale and distribution in the event a Conditional Marketing Authorization is received in the UK for use in patients hospitalized with COVID-19.
Lead Product(s): Lenzilumab,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Humaneered
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: PCI Pharma Services
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 16, 2022
Details:
Treatment with Orencia (abatacept) versus placebo displayed a strong but not statistically significant improvement in the primary endpoint of time to recovery as measured by day of hospital discharge.
Lead Product(s): Abatacept,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Orencia
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2022
Details:
The primary endpoint (90 day 6-category ordinal score) was not supportive (OR 1.10; 0.79 – 1.54; p=0.56), and 90-day mortality secondary endpoint was also not supportive with 37% mortality in Zyesami (aviptadil) group vs 36% in the placebo group; HR 1.04 (0.77-1.41); p=0.79.
Lead Product(s): Aviptadil Acetate,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: National Institutes of Health
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 25, 2022
Details:
OLUMIANT (baricitinib) is the first and only JAK inhibitor FDA-approved for the treatment of COVID-19 in certain hospitalized adults requiring various degrees of oxygen support.
Lead Product(s): Baricitinib,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Olumiant
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 11, 2022
Details:
U.S.FDA expanded approval of COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms with positive results of direct SARS-CoV-2 viral testing, who are Hospitalized, or Not hospitalized.
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 25, 2022
Details:
Approval is supported by Phase 2/3 data demonstrating the safety and tolerability profile and clinical improvement outcome in hospitalized pediatric patients treated with veklury (remdesivir).
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 25, 2022
Details:
New Post-hoc Analysis of Non-Hospitalized COVID-19 Patients in the Phase 3 PINETREE Study Demonstrates Veklury Treatment Initiated Within 5 Days of Symptoms Reduced Risk for Hospitalization by 90%.
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 24, 2022
Details:
Aviptadil is a synthetic form of Human Vasoactive Intestinal Polypeptide and was selected because of the potential to reduce inflammation and stabilize the air sacs of hospitalized because of injury from acute respiratory distress syndrome, which is the major cause of death.
Lead Product(s): Aviptadil Acetate,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: NRx Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2022
Details:
These latest data demonstrate that Veklury was generally well tolerated among pediatric patients hospitalized with COVID-19 with a high proportion of participants showing clinical improvement and recovery.
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 11, 2022
Details:
Veklury is the antiviral standard of care for the treatment of hospitalized patients with COVID-19 and is a recommended treatment for reducing disease progression in non-hospitalized patients at high risk of disease progression.
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury
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:
Approval Based on Phase 3 Data Showing Veklury Significantly Reduced Risk of Hospitalization By 87% Compared with Placebo, for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19.
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury
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 21, 2022
Details:
Topline results from the randomized EMPATHY Part A study in acute COVID-19 ambulatory patients comparing single intravenous doses of MP0420/SKO136 (ensovibep), a DARPin antiviral therapeutic candidate vs. placebo, met the primary endpoint of viral load reduction.
Lead Product(s): Ensovibep,Remdesivir,Sotrovimab
Therapeutic Area: Infections and Infectious Diseases Product Name: MP0420
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Molecular Partners
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 10, 2022
Details:
Study has found that an antiviral drug (Remdesivir) designed to inhibit the ability of the SARS-CoV-2 virus to reproduce itself is effective at preventing severe illness from COVID when given early in the symptom course.
Lead Product(s): Remdesivir
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 December 22, 2021
Details:
Veklury’s (remdesivir) antiviral activity has been tested in vitro against isolates of variants of SARS-CoV-2, including Alpha, Beta, Gamma, Delta, and Epsilon. These laboratory findings suggest that Veklury will continue to be active against the Omicron variant.
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2021
Details:
Laboratory studies using full Omicron pseudovirus confirm MP0420 (ensovibep), maintains ability to neutralize the variant with very high potency, relative to substantial reductions in neutralizing potency across numerous anti-SARS-CoV-2 antibody drugs.
Lead Product(s): Ensovibep,Remdesivir,Sotrovimab
Therapeutic Area: Infections and Infectious Diseases Product Name: MP0420
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 12, 2021
Details:
Humaneered (Lenzilumab), Phase 3 trial demonstrate treatment of hospitalized COVID-19 patients results in a statistically significant 54% relative improvement in survival without the need for invasive mechanical ventilation.
Lead Product(s): Lenzilumab,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Humaneered
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 01, 2021
Details:
In vitro data to-date demonstrate that ensovibep retains potency in inhibiting all known SARS-CoV-2 variants of concern, including the Delta variants. Ensovibep is the lead therapeutic candidate in Molecular Partners’ infectious disease pipeline.
Lead Product(s): Ensovibep,Remdesivir,Sotrovimab
Therapeutic Area: Infections and Infectious Diseases Product Name: MP0420
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2021
Details:
In this well-known assay, NV-CoV-2 was as effective as the neutralizing antibody in reducing the virus infection. This study demonstrates that NV-CoV-2 attacks the SARS-CoV-2 pseudovirion particles and renders them incapable of binding to the ACE2 positive cells.
Lead Product(s): NV-Cov-2,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: NV-Cov-2-R
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 11, 2021
Details:
ACTIV-3b is a randomized, placebo-controlled trial testing ZYESAMI™ and remdesivir (Veklury) -- alone and in combination -- in hospitalized patients with acute respiratory failure due to COVID-19 who require high-flow supplemental oxygen delivered by nasal cannula.
Lead Product(s): Aviptadil Acetate,Remdesivir,Dexamethasone
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: National Institutes of Health
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 29, 2021
Details:
NV-CoV-2-R comprised of holding remdesivir inside our polymeric drug candidate NV-CoV-2 by process known as encapsulation. The increased circulating level of intact remdesivir when given as NV-CoV-2-R encapsulated formulation without any increase in toxicity.
Lead Product(s): NV-Cov-2,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: NV-Cov-2-R
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 22, 2021
Details:
ZYESAMI™ (aviptadil) is a proprietary, synthetic version of Vasoactive Intestinal Peptide or VIP, which is made naturally in the human body and appears to have lung-protective, anti-viral and anti-inflammatory effects.
Lead Product(s): Aviptadil Acetate,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 18, 2021
Details:
Within ACTIV-5, lenzilumab is the first and only anti-human GM-CSF treatment to be tested in ACTIV-5 as a concomitant therapy with remdesivir compared with remdesivir alone.
Lead Product(s): Lenzilumab,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Humaneered
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Humanigen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 30, 2021
Details:
Remdesivir, sold under the brand name Veklury, was conditionally authorized in July last year for treating COVID-19 in adults and adolescents over 12 years with pneumonia requiring oxygen support.
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 21, 2021
Details:
Lupin has signed a royalty-free, limited, non-exclusive voluntary licensing agreement with Eli Lilly and Company (Lilly) for manufacturing and selling of Lilly’s drug Baricitinib in India.
Lead Product(s): Baricitinib,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Olumiant
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Lupin Ltd
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 10, 2021
Details:
Sun Pharma has entered into a royalty-free, non-exclusive voluntary licensing agreement with Eli Lilly and Company (“Lilly”) for expanding access to Lilly’s drug, baricitinib in India. Sun Pharma will manufacture and distribute the drug in India.
Lead Product(s): Baricitinib,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Olumiant
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sun Pharmaceutical Industries Limited
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 10, 2021
Details:
Natco Pharma has received Emergency Use approval for Baricitinib tablets, 1mg, 2mg and 4mg strengths from Central Drugs Standard Control Organization (CDSCO) in India. Baricitinib, in combination with Remdesivir, is used for treatment of COVID-19-positive patients.
Lead Product(s): Baricitinib,Remdesivir
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 May 03, 2021
Details:
Four HCV drugs, simeprevir, vaniprevir, paritaprevir, and grazoprevir-- in combination with remdesivir boosted the efficacy of remdesivir by 10-folds, the paper published in a reputed journal "Cell" reported.
Lead Product(s): Simeprevir,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2021
Details:
ACTIV-3b is a placebo trial which is going to study Zyesami – which is a synthetic version of a vasoactive peptide – and remdesivir alone and in combination against a placebo.
Lead Product(s): Aviptadil Acetate,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: National Institutes of Health
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 26, 2021
Details:
The randomized clinical trial is called ACTIV-3 Critical Care. It will begin by testing Zyesami, a formulation of aviptadil acetate, produced by NeuroRx, Wilmington, Delaware, and the antiviral remdesivir, developed by Gilead, Foster City, California.
Lead Product(s): Aviptadil Acetate,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Zyesami
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2021
Details:
Jubilant Pharmova has successfully completed safety and pharmacokinetic/absorption studies in animals and healthy human volunteers in India using a novel oral formulation of remdesivir against the commercially available injectable formulation of remdesivir.
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2021
Details:
The latest development comes after the Data Monitoring Committee recommended concluding the icatibant arm on enrolling 95 patients and the agent meeting the predefined futility criterion.
Lead Product(s): Icatibant Acetate,Dexamethasone,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
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 April 15, 2021
Details:
The trial's goal is to see which of two drug combinations—baricitinib plus remdesivir or dexamethasone plus remdesivir—is more effective at preventing hospitalisation in patients with COVID-19 progressing to mechanical ventilation or death, among other outcomes.
Lead Product(s): Baricitinib,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Olumiant
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 April 15, 2021
Details:
Based on the evolution of the COVID-19 landscape and challenges in enrolling this study, Gilead has decided to discontinue its Phase 3 Veklury® (remdesivir) intravenous (IV) study in high-risk non-hospitalized patients with COVID-19.
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 12, 2021
Details:
Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (hIVIG) clinical trial, also known as INSIGHT-013 did not meet its primary endpoints with statistically significant results.
Lead Product(s): Hyperimmune immunoglobulin,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: hIVIG
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: National Institutes of Health
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 02, 2021