Bavarian Nordic

Morris & Dickson is the First U.S. Distributor for Bavarian Nordic’s JYNNEOS®, the Only FDA-approved Mpox Vaccine

Retrieved on: 
Wednesday, April 3, 2024
Infectious Diseases, Pharmaceutical, Health, Disease, Smallpox, Virus, Mpox, Viral disease, Infection, CDC, Bavarian Nordic, Family, FDA, Pharmaceutical industry

Morris & Dickson is proud to announce it is the first U.S. distributor of Bavarian Nordic’s newly launched mpox vaccine, JYNNEOS®.

Key Points: 
  • Morris & Dickson is proud to announce it is the first U.S. distributor of Bavarian Nordic’s newly launched mpox vaccine, JYNNEOS®.
  • As the only FDA-approved mpox vaccine, JYNNEOS is now commercially available in the U.S., marking a significant expansion for access.
  • Bavarian Nordic announced its commercial entry into the US on April 2, noting the ongoing need for the vaccine.
  • “We are proud to be a key partner in expanding access to this first-to-market vaccine,” says Layne Martin, head of Specialty at Morris & Dickson.

Valneva Reports Full Year 2023 Revenue and Cash, Provides First 2024 Guidance

Retrieved on: 
Thursday, February 15, 2024
Total, Bavarian Nordic, Investment, Cash, Growth, Sale, Government, VLA, COVID-19, COVID, Third party, PRV, Chikungunya, Bank statement, Euronext Paris, Travel, OrbiMed

The Company will publish its 2023 audited consolidated financial statements on March 20, 2024.

Key Points: 
  • The Company will publish its 2023 audited consolidated financial statements on March 20, 2024.
  • Peter Bühler, Valneva’s Chief Financial Officer, commented, “In 2023, Valneva successfully executed on key strategic objectives despite a difficult economic environment.
  • Total revenues in 2022 included €280.0 million of revenue recognition mainly related to the COVID-19 supply agreements in the prior year.
  • Other income is anticipated between €95 million and €105 million, including the PRV sold in early 2024 for €95 million.

Bavarian Nordic Reports Positive Phase 3 Topline Results for Chikungunya Virus Vaccine in Adults and Adolescents

Retrieved on: 
Sunday, August 6, 2023
OMX, Biologics license application, CET, Vaccination, Infection, European Medicines Agency data breach, Immunity, Chikungunya, EDT, EMA, Nature, VLP, Adolescence, European Medicines Agency, Ageing, MAA, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, CHIKV, Disease, Vaccine, Bavarian Nordic

COPENHAGEN, Denmark, August 6, 2023 – Bavarian Nordic A/S (OMX: BAVA) announced today positive topline results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial ( NCT05072080 ) of its virus-like particle (VLP)-based chikungunya virus vaccine candidate, CHIKV VLP (PXVX0317) in adults and adolescents aged 12 to 64 years of age.

Key Points: 
  • COPENHAGEN, Denmark, August 6, 2023 – Bavarian Nordic A/S (OMX: BAVA) announced today positive topline results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial ( NCT05072080 ) of its virus-like particle (VLP)-based chikungunya virus vaccine candidate, CHIKV VLP (PXVX0317) in adults and adolescents aged 12 to 64 years of age.
  • A total of 3,254 participants were enrolled and randomized to receive either a single intramuscular injection of CHIKV VLP, or placebo.
  • “We are highly encouraged by the positive topline results now demonstrated in both Phase 3 studies of our chikungunya vaccine candidate.
  • “With a fast and durable response, our vaccine has the potential to be the best in class to prevent chikungunya infections in adolescents to elderly adults.

Bavarian Nordic Receives USD 120 Million Contract for the Manufacturing of Smallpox and Mpox Vaccine from the U.S. Government

Retrieved on: 
Thursday, August 3, 2023
Vaccine, OMX, Travel, Office of Inspector General, U.S. Department of Health and Human Services, Emergent BioSolutions, Emergent, USD, Government, Administration, Development, EBITDA, RSV, Acquisition, Administration for Strategic Preparedness and Response, Mpox, Bavarian Nordic, BARDA, Pharmaceutical industry

In addition, Bavarian Nordic will manufacture and supply additional liquid-frozen doses of the vaccine in 2023, valued at USD 3 million.

Key Points: 
  • In addition, Bavarian Nordic will manufacture and supply additional liquid-frozen doses of the vaccine in 2023, valued at USD 3 million.
  • The agreement includes additional services totalling USD 21 million, of which the majority will be received in 2024 and 2025.
  • Together with our U.S. manufacturing partner, we have completed the manufacturing of all doses ordered by the U.S. government during the mpox outbreak.
  • Revenue is now expected to be approximately DKK 6,900 million (previously approximately DKK 6,000 million) and EBITDA is now expected to be approximately DKK 2,300 million (previously approximately DKK 2,200 million).

Bavarian Nordic Reports Phase 3 Topline Results for its COVID-19 Booster Vaccine Candidate

Retrieved on: 
Tuesday, June 27, 2023
VLP, Vaccine, OMX, COVID-19, Pfizer–BioNTech COVID-19 vaccine, ABNCoV2, Bavarian Nordic, COVID, Vaccination, Safety, SARS-CoV-2

Booster study successfully met its primary objective, demonstrating non-inferiority to mRNA-vaccine

Key Points: 
  • Booster study successfully met its primary objective, demonstrating non-inferiority to mRNA-vaccine
    Regulatory pathway will depend upon the outcome of secondary endpoints, reporting in the third quarter of 2023
    COPENHAGEN, Denmark, June 27, 2023 – Bavarian Nordic A/S (OMX: BAVA) today reported topline results from a Phase 3 non-inferiority clinical trial of ABNCoV2, a VLP-based, non-adjuvanted COVID-19 booster vaccine candidate.
  • The two-part study enrolled a total of 4,205 adults who either previously completed primary vaccination or had already received one booster dose of a licensed COVID-19 vaccine.
  • Paul Chaplin, President and CEO of Bavarian Nordic said: “These Phase 3 results for our COVID-19 booster vaccine candidate have confirmed the VLP platform as a viable future pandemic vaccine platform.
  • Therefore, we have to generate additional data to assess the effectiveness of ABNCoV2 against the current circulating SARS-CoV-2 variants”.

Turbine Upsizes its Series A Round to €25.5 Million and Appoints Seasoned Independent Directors to its Board

Retrieved on: 
Tuesday, June 20, 2023
Biotechnology, Technology, Professional Services, Health, Oncology, Health Technology, Research, Data Analytics, Software, Artificial Intelligence, Science, MSD, CRISPR, Drug development, Genomics, Biogen, Intelligence, Bristol Myers Squibb, Genome, Biomarker, Princeton University, Harvard Medical School, Milind, Bayer, GPC Biotech, Genome Therapeutics Corporation, Novartis, Patient, Commercial Affairs Department, MMV, Machine learning, Drug combination, Corporation, Drug discovery, Sanofi, Faculty, Entrepreneurship, Merck, AI, Merck & Co., Bavarian Nordic, Massachusetts General Hospital, Therapy, Medical device, Pharmaceutical industry, Management, Turbine

This investment brings the company’s oversubscribed Series A round to €25.5 million and adds further U.S.-based investors to the company’s financing syndicate.

Key Points: 
  • This investment brings the company’s oversubscribed Series A round to €25.5 million and adds further U.S.-based investors to the company’s financing syndicate.
  • Alongside the funding, Turbine announced the appointments of four independent directors to its board.
  • They also have the capacity to perform assays that would be impractical to conduct at scale and with high throughput.
  • Dr. Wegner believes Turbine’s pairing of AI with advanced biotechnology gives it potential to powerfully impact the future of healthcare.

Bavarian Nordic Reports Data from a Phase 3 Clinical Trial of its VLP-Based Chikungunya Virus Vaccine in Adults ≥65 Years of Age

Retrieved on: 
Tuesday, June 20, 2023
VLP, OMX, Bavarian Nordic, Vaccination, Chikungunya, Safety, CHIKV, Vaccine

COPENHAGEN, Denmark, June 20, 2023 – Bavarian Nordic A/S (OMX: BAVA) announced today the initial safety and immunogenicity results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial of a virus-like particle (VLP)-based chikungunya virus (CHIKV) vaccine candidate CHIKV VLP (PXVX0317) in healthy adults ≥65 years of age.

Key Points: 
  • COPENHAGEN, Denmark, June 20, 2023 – Bavarian Nordic A/S (OMX: BAVA) announced today the initial safety and immunogenicity results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial of a virus-like particle (VLP)-based chikungunya virus (CHIKV) vaccine candidate CHIKV VLP (PXVX0317) in healthy adults ≥65 years of age.
  • Results from a second Phase 3 study evaluating the safety and immunogenicity of CHIKV VLP in healthy adolescents and adults 12 to 64 years old will report data during the third quarter of 2023.
  • A total of 413 participants were enrolled and randomized 1:1 to receive either a single intramuscular injection of CHIKV VLP or placebo.
  • They also match what has previously been reported for younger adults in an earlier Phase 2 study, including a fast onset of protection.

Emergent BioSolutions Finalizes Sale of Travel Health Business to Bavarian Nordic

Retrieved on: 
Monday, May 15, 2023
Vaccine, OMX, LLP, Travel, EBS, Sale, Patient, Wells Fargo, Barnes & Thornburg, NYSE, CHIKV, Emergent, Bavarian Nordic

GAITHERSBURG, Md., May 15, 2023 (GLOBE NEWSWIRE) -- Emergent BioSolutions (NYSE: EBS) today announced it has completed the sale of its travel health business to Bavarian Nordic (OMX: BAVA).

Key Points: 
  • GAITHERSBURG, Md., May 15, 2023 (GLOBE NEWSWIRE) -- Emergent BioSolutions (NYSE: EBS) today announced it has completed the sale of its travel health business to Bavarian Nordic (OMX: BAVA).
  • At closing Emergent received $270 million, subject to customary closing adjustments, and may receive up to an additional $110 million in potential future milestone payments.
  • Bavarian Nordic also acquired manufacturing facilities in Bern, Switzerland, and development facilities in San Diego, California.
  • The majority of Emergent employees supporting these products and facilities are joining Bavarian Nordic.

Emergent BioSolutions Reports Financial Results For First Quarter 2023

Retrieved on: 
Tuesday, May 9, 2023
Overalls, EBITDA, CDMO, Travel health nursing, GAAP, Travel, Smallpox, Investment, COVID, ID, Sale, Tourism, Pharmaceutical industry, Bank, Bavarian Nordic

OVERALL — Reflects the impact of the previously announced sale of the Travel Health business to Bavarian Nordic, which is anticipated to close in the second quarter.

Key Points: 
  • OVERALL — Reflects the impact of the previously announced sale of the Travel Health business to Bavarian Nordic, which is anticipated to close in the second quarter.
  • Anthrax MCM — Unchanged, reflecting assumptions that have remained constant regarding procurement and delivery of the Company's related products to the U.S. and allied governments.
  • (2) See "Reconciliation of Non-GAAP Measures" and the reconciliation tables for the definitions and reconciliations of these non-GAAP financial measures to the most closely related GAAP financial measures.
  • Company management will host a conference call at 5:00 pm eastern time today, May 9, 2023, to discuss these financial results.

Europe Monkeypox Testing Market Research Report 2023: An $18.33 Billion Market in 2022 - Industry Outlook and Forecasts to 2025 - ResearchAndMarkets.com

Retrieved on: 
Monday, March 13, 2023
Biotechnology, Pharmaceutical, Health, Central African, Contact tracing, CE, European Commission, Smallpox vaccine, USD, Risk, Bavarian Nordic, European Medicines Agency, Government, NAAT, Research, European, Monkeypox virus, IVD, Orthopoxvirus, Pregnancy, MPXV, NHS, MPX, Division of Acquired Immunodeficiency Syndrome, Standing Commission on Pay Comparability, DNA, PCR, Growth, Civil service commission, Partnership, Joint Committee on Vaccination and Immunisation, National Health Service, Infection, Privacy and the US government, Cepheid (company), Mpox, Cepheid variable, Roche, EMA, Person, Vaccine, Viral, Medical device, Pharmaceutical industry, Vaccination, EU

The "Europe Monkeypox Testing Market - Industry Outlook and Forecast 2023-2025" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Europe Monkeypox Testing Market - Industry Outlook and Forecast 2023-2025" report has been added to ResearchAndMarkets.com's offering.
  • The Europe monkeypox testing market was valued at USD 18,330.00 thousand in 2022 and is expected to reach USD 56.10 thousand by 2025.
  • Increasing cases and testing are driving the growth of the Europe monkeypox testing market.
  • The growing product launches of lateral flow assay kits are expected to create lucrative opportunities for the Europe monkeypox testing market growth.