Licensing, Pharmacokinetics and Virus

Selva Therapeutics Announces First Dosing in Phase 1 Clinical Study of SLV213, a Potential Oral Treatment for COVID-19

The Pharma Data

NOVEMBER 11, 2020

“As an orally bioavailable small molecule with broad antiviral activity, SLV213 could be a valuable treatment to meet today’s urgent need to fight COVID-19 as well other life-threatening infectious diseases, such as Chagas disease, Ebola virus disease, and Nipah virus infection.”. About Selva Therapeutics.

Treatment

Treatment Small Molecule Virus Pharmacokinetics

AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

The Pharma Data

AUGUST 22, 2021

AZD7442 is a combination of two LAABs – tixagevimab (AZD8895) and cilgavimab (AZD1061) – derived from B-cells donated by convalescent patients after SARS-CoV-2 virus. Under the terms of the licensing agreement with Vanderbilt, AstraZeneca will pay single-digit royalties on future net sales. About AstraZeneca. Yu XQ, et al.

Trials

Trials Vaccine Virus Pharmacokinetics

AbbVie Snatches Up Antibody from Harbour BioMed to Fight COVID-19 and Related Mutations

The Pharma Data

DECEMBER 14, 2020

Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. ” Under the license agreement, the development of ABBV-47D11 will be greatly advanced. Kate Krav-Rude/Shutterstock. before expanding it into Europe.

Licensing

Licensing Licensing Pharmacokinetics Clinical Trials

Codon Digest: Injected Gene Editors

Codon

APRIL 2, 2023

Therapeutic neutralizing monoclonal antibody administration protects against lethal yellow fever virus infection. Read A really simple way to isolate AAVs, which are a type of virus often used to deliver gene therapies into cells. Only about 15% of antibodies actually neutralize the new variants. Ricciardi M.J. Gene Therapy.

DNA

DNA RNA Engineering Licensing

Emergency Use Authorization request to FDA for VIR-7831 for the early treatment of COVID-19

The Pharma Data

MARCH 26, 2021

Data from the registrational COMET-ICE trial also will form the basis for a Biologics License Application (BLA) submission to the FDA. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection. About the Vir and GSK Collaboration.

Treatment

Treatment FDA Vaccine Trials

Molecular Partners Doses First Cohort in Phase 1 Trial of COVID-19 DARPin(R) Therapeutic Candidate MP0420

The Pharma Data

NOVEMBER 22, 2020

MP0420 is subject to an option and license agreement with Novartis AG to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin® program. MP0420 is designed to bind the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein at three distinct locations to prevent viral entry into cells.

Trials

Trials Clinical Trials Licensing Licensing

bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.

The Pharma Data

APRIL 16, 2021

1.429 California strain that currently accounts for 50 percent of the virus in California and over 10 percent across a number of additional states. Due to the rapidly evolving and geographically diverse nature of the SARS-CoV-2 virus, continued scientific innovation remains critical to develop additional treatments. In the U.S.,

Treatment

Treatment Hospitals Long-Term Care Facilities Virus

Advances in the Battle Against Autoimmune Disease

The Pharma Data

DECEMBER 15, 2020

The Phase I/IIa clinical trial is a randomized, double-blind, placebo controlled, single and multiple dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of NMD670 in 79 male and female healthy subjects and patients with myasthenia gravis. The secondary outcome involves pharmacokinetic endpoints.

Disease

Disease Clinical Trials Small Molecule Trials

Bamlanivimab alone with the U.S. government and is focusing on supply of bamlanivimab and etesevimab together

The Pharma Data

APRIL 14, 2021

It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science (IMCAS).

Government

Government Hospitals Long-Term Care Facilities Treatment

Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries | Eli Lilly and Company

The Pharma Data

MAY 4, 2021

About OLUMIANT ® (baricitinib) OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity.

Therapies

Therapies Hospitals Treatment FDA Approval

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

The Pharma Data

JANUARY 26, 2021

BLAZE-4 Additionally, initial results from the ongoing BLAZE-4 trial provide viral load and pharmacodynamic/pharmacokinetic data which demonstrated lower doses, including bamlanivimab 700 mg and etesevimab 1400 mg together, are similar to bamlanivimab 2800 mg and etesevimab 2800 mg together.

Hospitals

Hospitals Treatment Trials Long-Term Care Facilities

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

The Pharma Data

SEPTEMBER 15, 2020

The results demonstrated that Penta immune responses were robust and noninferior to licensed meningococcal vaccines (MenB and MenACWY) in individuals 10-25 years of age, regardless of prior MenACWY exposure. An update on Pfizer’s potential first-in-class maternal vaccine candidate for the prevention of respiratory syncytial virus (RSVpreF).

Vaccine

Vaccine Therapies Trials Clinical Trials

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

The Pharma Data

DECEMBER 5, 2020

Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. These allow for the creation of bispecific antibodies that closely resemble natural human antibodies with no linkers or artificial sequences.

Production

Production Trials Treatment Disease

Building collaborations to fight a pandemic

The Pharma Data

AUGUST 21, 2020

When COVID-19 began to emerge – first in Asia, then in Europe – she could see that its relative ease transmitting from person to person, along with the lack of tests and preventions or treatments for infection, made the virus a credible threat to humanity. What factors do you weigh when deciding whether to join a consortium? Source link.

Virus

Virus Small Molecule Licensing Licensing

Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19

The Pharma Data

JULY 23, 2021

Ronapreve is a combination of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed to block infectivity of SARS-CoV-2, the virus that causes COVID-19. The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process.

Treatment

Treatment Virus Clinical Trials Pharmaceuticals

Global Roundup: EU Approves ViiV’s HIV-1 Drug and More

The Pharma Data

DECEMBER 23, 2020

based Avacta Group entered into a license agreement with Astrea Bioseparations that allows that company to use Avacta’s Affimer platform in affinity purification applications. Peijia received an exclusive license regarding certain proprietary TMVR products currently in development by HighLife.

Licensing

Licensing Licensing Vaccine Trials

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

The Pharma Data

JANUARY 21, 2021

Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. Use in Specific Populations.

FDA Approval

FDA Approval Treatment RNA FDA

EMA issues advice on Lilly’s bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union

The Pharma Data

MARCH 5, 2021

It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science (IMCAS).

Treatment

Treatment Hospitals Long-Term Care Facilities Therapies

Lilly’s bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19

The Pharma Data

MARCH 11, 2021

It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science (IMCAS).

Hospitals

Hospitals Trials Long-Term Care Facilities Treatment

Drug Discovery Digest

Selva Therapeutics Announces First Dosing in Phase 1 Clinical Study of SLV213, a Potential Oral Treatment for COVID-19

AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

AbbVie Snatches Up Antibody from Harbour BioMed to Fight COVID-19 and Related Mutations

Codon Digest: Injected Gene Editors

Emergency Use Authorization request to FDA for VIR-7831 for the early treatment of COVID-19

Molecular Partners Doses First Cohort in Phase 1 Trial of COVID-19 DARPin(R) Therapeutic Candidate MP0420

bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.

Advances in the Battle Against Autoimmune Disease

Bamlanivimab alone with the U.S. government and is focusing on supply of bamlanivimab and etesevimab together

Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries | Eli Lilly and Company

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

Building collaborations to fight a pandemic

Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19

Global Roundup: EU Approves ViiV’s HIV-1 Drug and More

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

EMA issues advice on Lilly’s bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union

Lilly’s bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19

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