Infections and Infectious Diseases | Phase III Developments | UNITED KINGDOM

AstraZeneca PLC

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Astrazeneca to Begin Phase 1/2 Clinical Trials of Coronavirus Vaccine in Japan

Lead Product(s): ChAdOx1 nCoV-19

Therapeutic Area: Infections and Infectious Diseases Product Name: AZD1222

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 September 04, 2020

Details:

Trials of the vaccine, known as AZD1222, will be conducted at multiple facilities in Japan, targeting 250 subjects, the company said in a release.

Oxford Biomedica

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Oxford Biomedica Signs Supply Agreement with AstraZeneca to Expand Manufacturing Support of COVID-19 Vaccine Candidate, AZD1222

Lead Product(s): ChAdOx1 nCoV-19

Therapeutic Area: Infections and Infectious Diseases Product Name: AZD1222

Highest Development Status: Phase III Product Type: Vaccine

Partner/Sponsor/Collaborator: AstraZeneca PLC

Deal Size: $64.9 million Upfront Cash: $19.4 million

Deal Type: Agreement September 01, 2020

Details:

Oxford Biomedica has signed an 18 month supply agreement under a three year Master Supply and Development Agreement with AstraZeneca UK Ltd for large-scale commercial manufacture of the adenovirus vector-based COVID-19 vaccine candidate, AZD1222.

AstraZeneca PLC

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AstraZeneca Expands Development of Covid-19 Vaccine Azd1222 Into Us Phase III Clinical Trial Across All Adult Age Groups

Lead Product(s): ChAdOx1 nCoV-19

Therapeutic Area: Infections and Infectious Diseases Product Name: AZD1222

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 August 31, 2020

Details:

The trial is assessing efficacy and safety of the AZD1222 in all participants, and local and systemic reactions and immune responses will be assessed in 3,000 participants.

GlaxoSmithKline

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GlaxoSmithKline Announces First Participant Vaccinated in Phase 3 Clinical Trials of Its 5-in-1, Meningitis Abcwy Vaccine Candidate

Lead Product(s): Men ABCWY vaccine

Therapeutic Area: Infections and Infectious Diseases Product Name: GSK3536819A

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 August 19, 2020

Details:

The Phase 3 study is evaluating the safety, tolerability and immunogenicity of GSK’s MenABCWY vaccine candidate compared to Bexsero and Menveo in adolescents and young adults.

AstraZeneca PLC

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AstraZeneca will Work with Mexico, Argentina on COVID-19 Vaccine

Lead Product(s): ChAdOx1 nCoV-19

Therapeutic Area: Infections and Infectious Diseases Product Name: AZD1222

Highest Development Status: Phase III Product Type: Vaccine

Partner/Sponsor/Collaborator: Mexico Government

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement August 13, 2020

Details:

New agreement "builds on" the drugmaker's earlier deal with Brazil in June to supply around 30 million unfinished doses of the vaccine at a price tag of $127 million, or around $4 per dose.

AstraZeneca PLC

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Brazil's Bolsonaro Orders $360 million to Be Set Aside for AstraZeneca Coronavirus Vaccine

Lead Product(s): ChAdOx1 nCoV-19

Therapeutic Area: Infections and Infectious Diseases Product Name: AZD1222

Highest Development Status: Phase III Product Type: Vaccine

Partner/Sponsor/Collaborator: Brazilian Government

Deal Size: $356.0 million Upfront Cash: Undisclosed

Deal Type: Funding August 11, 2020

Details:

Brazilian Government issued a decree that will set aside 1.9 billion reais ($356 million) in funds to purchase and eventually produce the potential COVID-19 vaccine being developed by AstraZeneca PLC and Oxford University researchers.

Fujifilm Diosynth Biotechnologies

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Fujifilm to Begin Clinical Trials Testing Avigan in COVID-19 Patients in Kuwait

Lead Product(s): Favipiravir

Therapeutic Area: Infections and Infectious Diseases Product Name: Avigan

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Dr. Reddys Laboratories

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 21, 2020

Details:

Avigan (favipiravir) is an antiviral medication largely used to treat influenza in Japan. It was approved in the country in 2014 and became a generic drug in 2019.

Summit Therapeutics

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Summit Announces Publication of Phase 2 Clinical Analyses of Gut Microbiome Health

Lead Product(s): Ridinilazole

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 13, 2020

Details:

The data demonstrated that ridinilazole’s microbiome preservation resulted in a gut environment expected to inhibit the growth of C. difficile. In contrast, vancomycin treatment resulted in a gut environment that may more highly favor the growth of C. difficile.

Immodulon Therapeutics

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Immodulon Announces that IMM-101 will be Evaluated in World-First, Prophylactic Immuneboosting Strategy for COVID-19 in Cancer Patients

Lead Product(s): IMM-101

Therapeutic Area: Infections and Infectious Diseases Product Name: IMM-101

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 July 09, 2020

Details:

Phase 3 study approved by Health Canada seeks to boost cancer patients’ immune systems with IMM-101 to protect against severe COVID-19 and other viral lung infections.

AstraZeneca PLC

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AstraZeneca Tests Diabetes Drug Farxiga for COVID-19

Lead Product(s): Dapagliflozin

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 27, 2020

Details:

The study will test whether its protective effects extend to COVID-19, the disease caused by the new coronavirus that can lead to heart and kidney complications.

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AstraZeneca PLC

Astrazeneca to Begin Phase 1/2 Clinical Trials of Coronavirus Vaccine in Japan

Oxford Biomedica

Oxford Biomedica Signs Supply Agreement with AstraZeneca to Expand Manufacturing Support of COVID-19 Vaccine Candidate, AZD1222

AstraZeneca PLC

AstraZeneca Expands Development of Covid-19 Vaccine Azd1222 Into Us Phase III Clinical Trial Across All Adult Age Groups

GlaxoSmithKline

GlaxoSmithKline Announces First Participant Vaccinated in Phase 3 Clinical Trials of Its 5-in-1, Meningitis Abcwy Vaccine Candidate

AstraZeneca PLC

AstraZeneca will Work with Mexico, Argentina on COVID-19 Vaccine

AstraZeneca PLC

Brazil's Bolsonaro Orders $360 million to Be Set Aside for AstraZeneca Coronavirus Vaccine

Fujifilm Diosynth Biotechnologies

Fujifilm to Begin Clinical Trials Testing Avigan in COVID-19 Patients in Kuwait

Summit Therapeutics

Summit Announces Publication of Phase 2 Clinical Analyses of Gut Microbiome Health

Immodulon Therapeutics

Immodulon Announces that IMM-101 will be Evaluated in World-First, Prophylactic Immuneboosting Strategy for COVID-19 in Cancer Patients

AstraZeneca PLC

AstraZeneca Tests Diabetes Drug Farxiga for COVID-19