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Bavarian Nordic

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Bavarian Nordic Receives European Approval of Extension of Vaccine Label to Include Monkeypox

Details:

IMVANEX® (MVA-BN) is a non-replicating smallpox vaccine, to ensure supply of smallpox vaccine for entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines.

Lead Product(s): MVA-BN

Therapeutic Area: Infections and Infectious Diseases Product Name: Imvanex

Highest Development Status: Approved Product Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 25, 2022

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Bavarian Nordic Receives Positive CHMP Opinion on the Extension of Vaccine Label to Include Monkeypox

Details:

IMVANEX® (MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic) is a non-replicating smallpox vaccine, that is extended to include protecting people from monkeypox disease.

Lead Product(s): MVA-BN

Therapeutic Area: Infections and Infectious Diseases Product Name: Imvanex

Highest Development Status: Approved Product Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 22, 2022

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Bavarian Nordic

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HHS Orders 2.5 Million More Doses of JYNNEOS Vaccine For Monkeypox Preparedness

Details:

BARDA supported the development of JYNNEOS, which is approved by the FDA to prevent smallpox and monkeypox. The U.S. government owns enough smallpox vaccine – JYNNEOS and ACAM2000 – to vaccinate millions of Americans.

Lead Product(s): Live Nonreplicating Smallpox and Monkeypox Vaccine

Therapeutic Area: Infections and Infectious Diseases Product Name: Jynneos

Highest Development Status: Approved Product Type: Vaccine

Partner/Sponsor/Collaborator: U.S. Department of Health and Human Services

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement July 01, 2022

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Bavarian Nordic

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Bavarian Nordic Enters Vaccine Supply Contract with the European Health Emergency Preparedness and Response Authority (HERA) in Response to Monkeypox Outbreak

Details:

MVA-BN or Modified Vaccinia Ankara (marketed as IMVANEX® in Europe, JYNNEOS® in the U.S. and IMVAMUNE® in Canada) is a non-replicating smallpox vaccine developed in collaboration with the U.S. government to ensure supply of a smallpox vaccine for the entire population.

Lead Product(s): MVA-BN

Therapeutic Area: Infections and Infectious Diseases Product Name: IMVANEX

Highest Development Status: Approved Product Type: Vaccine

Partner/Sponsor/Collaborator: Health Emergency Preparedness and Response Authority

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement June 14, 2022

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Bavarian Nordic Secures Vaccine Order from European Country After Confirmed Monkeypox Cases

Details:

Bavarian Nordic’s smallpox vaccine is approved in the U.S as JYNNEOS and in Canada as IMVAMUNE, both places with the approval extended to cover the monkeypox indication. The vaccine is approved in Europe as IMVANEX (Live Modified Vaccinia Virus Ankara) for smallpox indication.

Lead Product(s): Live Modified Vaccinia Virus Ankara

Therapeutic Area: Infections and Infectious Diseases Product Name: Imvanex

Highest Development Status: Approved Product Type: Vaccine

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement May 19, 2022

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Bavarian Nordic to Manufacture First Freeze-dried Doses of Smallpox Vaccine upon Exercise of Contract Option by the U.S. Government

Details:

MVA-BN, (Modified Vaccinia Ankara - Bavarian Nordic) is a proprietary and patented vaccine platform technology, robust and adaptable platform suitable for addressing a wide variety of infectious diseases and cancers.

Lead Product(s): MVA-BN

Therapeutic Area: Infections and Infectious Diseases Product Name: Imvanex

Highest Development Status: Approved Product Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 17, 2022

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Xellia Pharmaceuticals ApS

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Xellia Pharmaceuticals expands approved doses of VANCO READY™ (Ready-to-use Premixed Vancomycin bags)

Details:

Xellia Pharmaceuticals has received approval for 3 additional dosages of VANCO READY™, expanding its range of room-temperature-stable, ready-to-use (RTU) Vancomycin injection premix bags.

Lead Product(s): Vancomycin Hydrochloride

Therapeutic Area: Infections and Infectious Diseases Product Name: Vanco Ready

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 September 02, 2020

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Bavarian Nordic Announces Positive Topline Results from Phase 3 Clinical Study of Freeze-dried Smallpox Vaccine

Details:

The three lots of MVA-BN induced similar antibody responses, meeting the study's primary endpoint, while the favourable safety profile was also confirmed without severe adverse reactions.

Lead Product(s): MVA-BN

Therapeutic Area: Infections and Infectious Diseases Product Name: MVA-BN

Highest Development Status: Approved Product Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 24, 2020

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