Emergent BioSolutions Inc. engages in the development, manufacture, and commercialization of medical countermeasures. It offers products for civilian and military populations that address accidental, intentional, and naturally occurring public health threats. The firm's products include ACAM2000, BioThrax, Raxibacuma, Vaxchora, and VIGIV. Its business units include Vaccines and Anti-Infectives, Antibody Therapeutics, Devices, and Contract Development and Manufacturing. The company was founded by Fuad El-Hibri on September 5, 1998 and is headquartered in Gaithersburg, MD.
相关临床试验
47
7 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
已完成
35
74.5%
Enrolling By Invitation
2
4.3%
尚未招募
5
10.6%
终止
5
10.6%
暂无批准数据
- The European Commission has extended Imvanex (MVA-BN) marketing authorization to children aged 2 to less than 12 years, making it the only non-replicating mpox vaccine approved for all individuals aged 2 and older in the EU. - The approval is supported by a Phase II study (NCT06549530) demonstrating non-inferior immune responses in children compared to adults, with similar safety profiles between both populations. - Children have been disproportionately affected during recent mpox outbreaks, particularly in Africa, and this label extension addresses a critical regulatory gap for a vulnerable population. - MVA-BN's non-replicating profile makes it suitable for immunocompromised individuals, distinguishing it from replication-competent vaccines like ACAM2000 that carry contraindications in this population.
- The global vaccine sales market is projected to reach US$141.40 billion by 2036, driven by next-generation platforms including mRNA and viral vector technologies. - U.S. tariff policies and cross-border supply chain vulnerabilities are reshaping competitive strategy, with manufacturers localizing production and diversifying suppliers to manage cost pressures. - Competition is increasingly defined by platform capabilities, regulatory credentials, manufacturing scale, and access to government and multilateral procurement contracts. - The report profiles 21 leading vaccine companies including GSK, Pfizer, Sanofi, Moderna, Merck, BioNTech, AstraZeneca, and Serum Institute of India, with forecasts across 26 national markets.
- The FDA approved Rextovy, a new 4 mg over-the-counter naloxone hydrochloride nasal spray from Amphastar Pharmaceuticals, for emergency opioid overdose reversal. - This approval broadens consumer access, allowing purchase without a prescription at pharmacies, convenience stores, and online marketplaces. - U.S. overdose deaths dropped from 111,451 (12 months ending August 2023) to 68,632 (12 months ending December 2025), coinciding with expanded OTC naloxone availability. - The FDA emphasizes that multiple OTC naloxone options drive market competition, potentially lowering retail costs and increasing community distribution.
- Emergent BioSolutions announced a multi-year, $50 million manufacturing agreement with SAB Biotherapeutics to support development and production of SAB-142, a novel therapy for autoimmune type 1 diabetes. - SAB-142 represents a disease-modifying therapeutic approach that aims to delay onset and potentially prevent progression of Stage 3 type 1 diabetes, currently being evaluated in a registrational Phase 2b trial. - The agreement leverages Emergent's Winnipeg facility for end-to-end manufacturing services, with $36 million contingent on regulatory approval and commercial milestones. - SAB Biotherapeutics utilizes proprietary transchromosomic cattle technology to produce human immunoglobulin G antibodies without requiring human donors or convalescent plasma.
- Multiple pharmaceutical companies including Bavarian Nordic, BioNTech, and Moderna are advancing innovative monkeypox vaccines and treatments through clinical trials and regulatory approvals. - Bavarian Nordic's JYNNEOS vaccine provided broad coverage during the 2022-2023 outbreak, while the company seeks regulatory extension for adolescent use of IMVANEX. - mRNA-based vaccine candidates from Moderna (mRNA-1769) and BioNTech (BNT166a) are progressing through clinical trials to enhance immune responses against monkeypox. - Recent developments include TC BioPharm initiating preclinical studies for TCB 008 and preliminary results from NIH trials on SIGA's tecovirimat treatment.
- Emergent BioSolutions announced a collaboration agreement with PANTHER to provide additional financial support for the Africa CDC-led 'MpOx Study in Africa' (MOSA), a double-blind, platform-adaptive clinical trial evaluating potential mpox treatments. - An independent data and safety monitoring board completed its initial review of MOSA safety data in December 2025 after the first 50 patients were randomized and recommended trial continuation with no safety concerns identified. - Africa has reported more than 61,383 confirmed mpox cases and 296 deaths across 32 countries since the beginning of 2024, with both major clades present including the more severe Clade I endemic to Central Africa. - The study plans to extend to new countries including Uganda as researchers work to develop treatments for mpox, a virus for which there is currently no dedicated antiviral therapy.
- Emergent BioSolutions received U.S. FDA approval for its supplemental Biologics License Application to manufacture raxibacumab, a monoclonal antibody for inhalational anthrax treatment, at its Winnipeg, Canada facility. - The approval supports the company's multi-year transformation strategy to consolidate manufacturing operations at two primary sites in Winnipeg and Lansing, Michigan. - Raxibacumab is indicated for treatment and prophylaxis of inhalational anthrax in combination with antibacterial drugs, with effectiveness based solely on animal model studies. - The Winnipeg facility brings over 45 years of therapeutic manufacturing experience and maintains comprehensive drug substance, fill/finish, and analytical testing capabilities.
- Emergent BioSolutions received a $17 million contract modification from BARDA to supply TEMBEXA (brincidofovir) oral suspension for smallpox treatment. - The FDA recently approved manufacturing scale-up of the oral suspension formulation, which is crucial for patients who have difficulty swallowing. - TEMBEXA is an orthopoxvirus nucleotide analog DNA polymerase inhibitor approved in June 2021 for treating human smallpox disease in all age groups. - The contract builds upon previous options from September 2024 under Emergent's existing 10-year agreement with the U.S. government.
- The Korean Ministry of Food and Drug Safety approved BARYTHRAX, the world's first recombinant protein-based anthrax vaccine developed by GC Biopharma and the Korea Disease Control and Prevention Agency. - The vaccine eliminates toxin exposure risks associated with traditional anthrax vaccines by using protective antigen proteins produced through genetic recombination techniques. - BARYTHRAX demonstrated high safety and efficacy in clinical trials, with vaccinated subjects generating sufficient neutralizing antibodies and maintaining high survival rates in animal studies. - The approval enables South Korea to achieve self-sufficiency in anthrax vaccine production, ending reliance on imports and potentially opening export markets globally.
• A recent study published in The Lancet Infectious Diseases found Bavarian Nordic's Jynneos vaccine was 84% effective in preventing mpox in individuals without HIV, but only 35% effective in those with HIV. • The research, conducted at Charité Universitätsmedizin Berlin with over 6,000 participants, highlights a significant unmet need for effective mpox prevention strategies in immunocompromised populations. • While the vaccine showed an overall 58% effectiveness after one dose, researchers emphasize the importance of completing the two-dose regimen, particularly for HIV-positive individuals who demonstrated reduced T-cell responses.
