BARDA

Emergent BioSolutions Announces Strategic Steps to Strengthen Core Business and Financial Position

Retrieved on: 
Tuesday, August 8, 2023
BAT, Travel, ACAM2000, EBS, RSDL, Public, Ebola, Smallpox, Sale, Government, CDMO, OTC, Growth, FDA, Anthrax, BARDA, NYSE, Pharmaceutical industry, Vaccine, Emergent

GAITHERSBURG, Md., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Emergent BioSolutions (NYSE: EBS) today announced it is reducing investment in and de-emphasizing focus on growth in its CDMO services business. As a result, Emergent is reducing operations at its Bayview facility in Baltimore, Maryland.

Key Points: 
  • Going forward, Emergent will focus on its core products business – medical countermeasures and NARCAN® Nasal Spray –and on delivering for its existing customers, including the U.S. and allied governments.
  • Emergent will maintain a level of operations at both Bayview and Canton to ramp up production in response to new demand.
  • “The actions we are taking will further strengthen our core products business and financial foundation,” said Emergent interim Chief Executive Officer Haywood Miller.
  • As a result of the strategic shift away from Emergent’s services business, the company is eliminating the chief operating officer (COO) role.

Arcturus Therapeutics Announces Second Quarter 2023 Financial Update and Pipeline Progress

Retrieved on: 
Monday, August 7, 2023
COVID-19, Research, Infectious Diseases, FDA, Genetics, Clinical Trials, Biotechnology, Pharmaceutical, Health, Science, Vaccine, Diversified Specialty Institute Holdings, Inc., Travel, Omicron, Arcturus Therapeutics, Vaccination, Marketing, SARS-CoV-2, Ornithine transcarbamylase deficiency, Infection, NDA, Pfizer–BioNTech COVID-19 vaccine, ARCT, Meiji, CSL, Multimedia, RNA, Messenger, Government, Ministry, CGMP, Patient, MedRxiv, OTC, Cystic fibrosis, Geometry, Liver, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BARDA, Food, MNT, Pharmaceutical industry, Cryptocurrency, Arcturus

Superiority of ARCT-154 in neutralizing antibody response against SARS-CoV-2 Omicron BA.4/5 variant was also demonstrated as a key secondary endpoint.

Key Points: 
  • Superiority of ARCT-154 in neutralizing antibody response against SARS-CoV-2 Omicron BA.4/5 variant was also demonstrated as a key secondary endpoint.
  • Revenue decreased by $16.6 million during the three months ended June 30, 2023 as compared to the prior year period.
  • We have collected approximately $300.0 million in upfront payments and milestones from CSL Seqirus as of June 30, 2023.
  • Additionally, we received $23.6 million under the manufacturing and supply of ARCT-154 from CSL Seqirus during the quarter ended June 30, 2023.

Basilea announces submission of a New Drug Application to the US Food and Drug Administration for its antibiotic ceftobiprole

Retrieved on: 
Friday, August 4, 2023
SAB, Infection, ASPR, Priority review, US Foods, Partnership, Biomedical Advanced Research and Development Authority, HHS, QIDP, Bronchopneumonia, Methicillin-resistant Staphylococcus aureus, MRSA, Administration for Strategic Preparedness and Response, LR, NDA, CABP, Fungal infection, Ceftobiprole, ABSSSI, GAIN, Administration, Development, Patient, Disease, Mortality, FDA, Safety, BARDA, TARGET, Food, Pharmaceutical industry, Vaccine, Allschwil, Basel

The additional successfully completed phase 3 studies in ABSSSI and CABP support the broad clinical utility of ceftobiprole.

Key Points: 
  • The additional successfully completed phase 3 studies in ABSSSI and CABP support the broad clinical utility of ceftobiprole.
  • Provided that the NDA submission is accepted, Basilea expects a decision by the FDA on the NDA in the second quarter of 2024.
  • Basilea plans to commercialize ceftobiprole in the US through a partner and intends to enter into such a partnership prior to the FDA’s decision on the NDA.
  • Basilea has been awarded approximately USD 112 million, or approximately 75 percent of the costs related to the SAB and ABSSSI phase 3 studies, regulatory activities and non-clinical work.

Cue Health Awarded New $28 Million Federal Contract to Develop Flu A/B, RSV, COVID-19 Molecular Multiplex Test for Both Over-the-Counter and Point-of-Care Use

Retrieved on: 
Thursday, August 3, 2023
Medical Supplies, Biotechnology, Other Health, Health, General Health, Pharmaceutical, Health Technology, Research, Infectious Diseases, Science, COVID-19, EUA, United States Department of Health and Human Services, Biomedical Advanced Research and Development Authority, Partnership, De novo, Office of Inspector General, U.S. Department of Health and Human Services, HHS, Influenza, Classification, Hospital, Human services, Mpox, Administration for Strategic Preparedness and Response, Respiratory syncytial virus, CDC, Reader, Administration, Development, RSV, Korea Disease Control and Prevention Agency, OTC, POC, FDA, BARDA, Cue, Virus, Vaccine, Pharmaceutical industry

The company has also applied with the U.S. FDA for Emergency Use Authorization (EUA) for its Cue Flu + COVID-19 Molecular Test for at-home and point-of-care (POC) use.

Key Points: 
  • The company has also applied with the U.S. FDA for Emergency Use Authorization (EUA) for its Cue Flu + COVID-19 Molecular Test for at-home and point-of-care (POC) use.
  • Cue also requested De Novo classification from the FDA for the Cue RSV Molecular Test for at-home and point-of-care use.
  • Cue also recently received De Novo authorization from the FDA for the same COVID-19 test (Cue COVID-19 Molecular Test), which was the first De Novo granted for any home use respiratory test available without a prescription.
  • The Cue molecular tests all run on the Cue Health Monitoring System (Reader), which has an installed base of more than a quarter million.

Paratek Pharmaceuticals Announces Second Quarter 2023 Revenue of $40.0 Million

Retrieved on: 
Thursday, August 3, 2023
Post-exposure prophylaxis, Oaktree Capital Management, PEP, Biomedical Advanced Research and Development Authority, CVR, U.S. Department of Defense Strategy for Operating in Cyberspace, Public, Human services, Office of Inspector General, U.S. Department of Health and Human Services, European Medicines Agency, Calendar, European Commission, Government, Committee, Administration, Development, Anthrax, NTM, Novo Holdings A/S, Gurnet Point, Massachusetts, Acquisition, Administration for Strategic Preparedness and Response, Comment, Novo Nordisk Foundation, Rabbit, Research, Contingent value rights, BARDA, Video game, Pharmaceutical industry, Vaccine, Music

BOSTON, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), (“Paratek” or “the Company”), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and other public health threats for civilian, government and military use, today reported financial results and provided an update on corporate activities for the second quarter ended June 30, 2023.

Key Points: 
  • Total revenue for the second quarter of 2023 was $40.0 million compared to $29.6 million for the same period in the prior year.
  • Total revenue for the second quarter of 2023 was comprised of the following:
    NUZYRA net U.S. sales of $33.8 million, which represented a 35% increase from $25.1 million for the same period in the prior year.
  • Research and development (“R&D”) expenses were $8.8 million for the second quarter of 2023, compared to $7.6 million for the same period in the prior year.
  • Selling, general and administrative (“SG&A”) expenses were $36.3 million for the second quarter of 2023, compared to $30.3 million for the same period in the year.

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).

Emergent BioSolutions Awarded 10-Year BARDA Contract Valued at up to a Maximum of $704 Million for Advanced Development and Procurement of Ebanga™ Treatment for Ebola

Retrieved on: 
Monday, July 31, 2023
ASPR, Emergent BioSolutions, Partnership, Biomedical Advanced Research and Development Authority, Office of Inspector General, U.S. Department of Health and Human Services, HHS, EBS, Ebola, Emergent, Global health, Government, Science, Administration, Development, Risk, Administration for Strategic Preparedness and Response, EVD, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BARDA, NYSE, Food, Pharmaceutical industry

“For almost 25 years, Emergent has tackled the most serious diseases to assist governments in their preparedness and response strategies,” said Dr. Kelly Warfield, senior vice president, science and development at Emergent.

Key Points: 
  • “For almost 25 years, Emergent has tackled the most serious diseases to assist governments in their preparedness and response strategies,” said Dr. Kelly Warfield, senior vice president, science and development at Emergent.
  • “Ebola virus has the ability to emerge unexpectedly posing a risk to global health.
  • If all option periods are exercised, the total contract value will be valued at up to approximately $704 million.
  • This project has been funded in whole or in part with federal funds from HHS; ASPR; BARDA, under contract number 75A50123C00037.

Revive Therapeutics Announces Filing of Patent for Bucillamine in the Treatment of Exposure to Chemical Warfare Agents

Retrieved on: 
Friday, July 28, 2023
ASPR, Plastic, Biomedical Advanced Research and Development Authority, CSE, Petroleum, Therapy, U.S. Department of Defense Strategy for Operating in Cyberspace, Chemical warfare, Human services, Fertilizer, Office of Inspector General, U.S. Department of Health and Human Services, Research, Disorder, Ricin, RVV, Development, Administration, Pesticide, Patent, Privacy Office of the U.S. Department of Homeland Security, Administration for Strategic Preparedness and Response, Conventional weapon, Paper, Textile, BARDA, Nerve, Pharmaceutical industry, Bucillamine

TORONTO, July 28, 2023 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, today announced that it has filed a provisional patent application titled “Compositions, methods and uses of Bucillamine in the treatment of a victim exposed to a chemical warfare agent.”

Key Points: 
  • TORONTO, July 28, 2023 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, today announced that it has filed a provisional patent application titled “Compositions, methods and uses of Bucillamine in the treatment of a victim exposed to a chemical warfare agent.”
    The methods and compositions described in the patent application relate to Bucillamine as a potential treatment of a victim exposed to a chemical agent, including chemical warfare agents such as sulfur mustards, nitrogen mustards, nerve agents of G and V type, lewisite and adamsite.
  • According to the U.S. Department of Homeland Security, a chemical attack is the spreading of toxic chemicals with the intent to do harm, which may include chemical weapons (warfare agents) developed for military use, toxic industrial and commercial chemicals that are produced, transported, and stored in the making of petroleum, textiles, plastics, fertilizers, paper, foods, pesticides, household cleaners, and other products, and chemical toxins of biological origin such as ricin.
  • The Company is commencing to work with advisors in developing a strategic plan to present its case in repurposing Bucillamine as a potential medical countermeasure for chemical warfare agent exposures to the Biomedical Advanced Research and Development Authority (BARDA), a part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services.
  • At this time, the Company will only provide regular updates via press releases as information becomes available.

SIGA Announces U.S. Government Procurement Orders of Approximately $138 Million for Oral and IV TPOXX®

Retrieved on: 
Thursday, July 27, 2023
Biomedical Advanced Research and Development Authority, Strategic National Stockpile, IV, Office of Inspector General, U.S. Department of Health and Human Services, Human services, U.S. Department of Defense Strategy for Operating in Cyberspace, Administration for Strategic Preparedness and Response, TPOXX, Administration, Development, SIGA Technologies, Shipbuilding contract, BARDA, Vaccine

NEW YORK, July 27, 2023 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company, today announced that the U.S. Department of Health and Human Services exercised procurement options for the delivery of approximately $113 million worth of oral TPOXX® treatment courses and approximately $25 million worth of IV TPOXX® treatment courses.

Key Points: 
  • NEW YORK, July 27, 2023 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company, today announced that the U.S. Department of Health and Human Services exercised procurement options for the delivery of approximately $113 million worth of oral TPOXX® treatment courses and approximately $25 million worth of IV TPOXX® treatment courses.
  • “Building on the orders SIGA received for TPOXX from 13 international customers and the U.S. Department of Defense in 2022, these most recent procurement orders further highlight that many global leaders in public heath recognize the importance of orthopoxvirus preparedness and the need to take action to keep people safe,” said Phil Gomez, CEO of SIGA.
  • “We are pleased that we are able to consistently meet demand for oral TPOXX, which is driving substantial and increasingly diversified global revenue opportunities at SIGA.”
    SIGA expects to fully deliver approximately $113 million of oral TPOXX under this order in 2023 and expects to start delivering IV TPOXX under this order in 2024.
  • Prior to delivery of IV TPOXX under this order, SIGA will be focused on fulfilling delivery obligations under a prior IV TPOXX order.

Emergent BioSolutions Receives U.S. FDA Approval of CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted), previously known as AV7909, a Two-Dose Anthrax Vaccine for Post-Exposure Prophylaxis Use

Retrieved on: 
Thursday, July 20, 2023
Post-exposure prophylaxis, Biologics license application, Emergent BioSolutions, Partnership, Biomedical Advanced Research and Development Authority, DARPA, Office of Inspector General, U.S. Department of Health and Human Services, EBS, Human services, Public, National Institute of Allergy and Infectious Diseases, U.S. Department of Defense Strategy for Operating in Cyberspace, Infection, Person, Bangladesh Technical Education Board, Government, Science, Trial of the century, Bacillus anthracis, Administration, Development, Anthrax, Administration for Strategic Preparedness and Response, AVA, NIAID, FDA, Anthrax vaccine adsorbed, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BARDA, NYSE, Food, Safety, Disease, Pharmaceutical industry, Vaccine, Emergent, Adjuvant

The efficacy of CYFENDUS™ vaccine for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax.

Key Points: 
  • The efficacy of CYFENDUS™ vaccine for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax.
  • “The 20-year journey from early development to approval is a major milestone that attests to Emergent's scientific and technical prowess and partnering capabilities.
  • “The approval of the CYFENDUS™ vaccine demonstrates what effective public-private partnerships can achieve for national security.
  • In December 2018, CYFENDUS™ vaccine was the subject of a pre-emergency use authorization package submitted to the FDA.