Emergency Use Authorization

Rigel Announces Presentation at the Upcoming IDWeek 2023

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수요일, 10월 11, 2023
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SOUTH SAN FRANCISCO, Calif., Oct. 11, 2023 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced an upcoming oral presentation highlighting data from the FOCUS Phase 3 clinical trial of fostamatinib in hospitalized COVID-19 patients without respiratory failure who have certain high-risk prognostic factors at IDWeek 2023 being held October 11-15, 2023, in Boston, MA and provided an update on the ACTIV-4 Host Tissue trial of fostamatinib in hospitalized patients with COVID-19.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Oct. 11, 2023 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced an upcoming oral presentation highlighting data from the FOCUS Phase 3 clinical trial of fostamatinib in hospitalized COVID-19 patients without respiratory failure who have certain high-risk prognostic factors at IDWeek 2023 being held October 11-15, 2023, in Boston, MA and provided an update on the ACTIV-4 Host Tissue trial of fostamatinib in hospitalized patients with COVID-19.
  • However, our focus remains on our hematology-oncology commercial and clinical portfolio," said Raul Rodriguez, Rigel's president and CEO.
  • Patients were randomly assigned 1:1 to receive fostamatinib (150 mg BID administered orally) or placebo for 14 days.
  • A significantly higher proportion of patients who received fostamatinib were discharged from the hospital by Day 15 compared to placebo (p=0.0029).

Pfizer and BioNTech Receive U.S. FDA Approval for 2023-2024 COVID-19 Vaccine

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월요일, 9월 11, 2023
Science, Biotechnology, Research, Pharmaceutical, Health, FDA, COVID-19, Infectious Diseases, EUA, BioNTech, SARS-CoV-2, Vaccine, Heart, US Foods, Inc., Pirola, Omicron, Civil service commission, Tell, Vaccination, Face, Pharmacy, PFE, Coronavirus, Weakness, VRBPAC, Inflammation, Messenger, Rash, CDC, Formula, Emergency Use Authorization, COVID-19 vaccine, Hospital, Allergy, Dizziness, Risk, Child, Korea Disease Control and Prevention Agency, XBB, European, Viral, Adolescence, BNTX, VAERS, United Kingdom, Pounding, Ageing, Regulation of tobacco by the U.S. Food and Drug Administration, Safety, NYSE, FD, Food, European Commission, Disease, Pericarditis, Pharmaceutical industry, Petroleum jelly, Poultry farming, Myocarditis, Pfizer

Children under the age of 5 may be eligible to receive additional doses of this season’s vaccine if they have not already completed a three-dose series with previous formulations of a COVID-19 vaccine.

Key Points: 
  • Children under the age of 5 may be eligible to receive additional doses of this season’s vaccine if they have not already completed a three-dose series with previous formulations of a COVID-19 vaccine.
  • Pfizer and BioNTech have submitted data for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine to other regulatory authorities around the world.
  • The COVID-19 vaccines (COMIRNATY®) by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies.
  • Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS).

Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron XBB.1.5-adapted COVID-19 Vaccine in the European Union

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수요일, 8월 30, 2023
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View the full release here: https://www.businesswire.com/news/home/20230829323192/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230829323192/en/
    The European Commission (EC) will review the CHMP’s recommendation and is expected to make a final decision soon.
  • Following a decision from the EC, the updated vaccine will be ready to ship to applicable EU member states immediately.
  • “Omicron XBB-related sublineages are antigenically distant from prior Omicron strains and continue to account for the vast majority of COVID-19 cases globally.
  • Further, the application included pre-clinical data showing that the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine generates a substantially improved response against multiple XBB sublineages, including XBB.1.5, XBB.1.16, and XBB.2.3, compared to the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine.

InflaRx’s Marketing Authorization Application (MAA) for Vilobelimab for Treatment of Critically Ill COVID-19 Patients under Review by European Medicines Agency (EMA)

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수요일, 8월 30, 2023
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This means that the application is now under regulatory review by the European Committee for Medicinal Products for Human Use (CHMP) under the centralized procedure, which applies to all 27 member states of the European Union (EU).

Key Points: 
  • This means that the application is now under regulatory review by the European Committee for Medicinal Products for Human Use (CHMP) under the centralized procedure, which applies to all 27 member states of the European Union (EU).
  • InflaRx submitted the MAA to EMA in July 2023 following interactions with the rapporteur and co-rapporteur teams of the CHMP.
  • The results showed that vilobelimab treatment improved survival with a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in the global data set.
  • “We are pleased that EMA has accepted our MAA submission and that it is now under review.

Regeneron Announces Agreement with BARDA Supporting Development of Next-Generation Antibody Therapy for COVID-19 Prevention

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화요일, 8월 22, 2023
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TARRYTOWN, N.Y., Aug. 22, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the Biomedical Advanced Research and Development Authority (BARDA) has entered into an agreement with Regeneron to support clinical development, clinical manufacturing and the regulatory licensure process of a next-generation COVID-19 monoclonal antibody therapy for the prevention of SARS-CoV-2 infection.

Key Points: 
  • TARRYTOWN, N.Y., Aug. 22, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the Biomedical Advanced Research and Development Authority (BARDA) has entered into an agreement with Regeneron to support clinical development, clinical manufacturing and the regulatory licensure process of a next-generation COVID-19 monoclonal antibody therapy for the prevention of SARS-CoV-2 infection.
  • We believe Regeneron can once again apply our drug discovery and development expertise to help prevent disease in vulnerable populations.
  • Regeneron’s most advanced next-generation antibody candidate under this agreement is expected to enter clinical trials later this year.
  • The next-generation antibody project is being funded in part with federal funds from BARDA under OT number: HHSO100201700020C.

Novavax's Updated Protein-based XBB COVID Vaccine Induced Neutralizing Responses Against Emerging Subvariants, Including EG.5.1 and XBB.1.16.6

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화요일, 8월 22, 2023
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Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.

Key Points: 
  • Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.
  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
  • Limitations of Vaccine Effectiveness: The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients.
  • The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.

Novavax's Updated Protein-based XBB COVID Vaccine Induced Neutralizing Responses Against Emerging Subvariants, Including EG.5.1 and XBB.1.16.6

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화요일, 8월 22, 2023
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Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.

Key Points: 
  • Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.
  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
  • Limitations of Vaccine Effectiveness: The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients.
  • The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.

BD Receives 510(k) Clearance for COVID-19, Influenza A/B, RSV Molecular Combination Test

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화요일, 8월 1, 2023
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FRANKLIN LAKES, N.J., Aug. 1, 2023 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Respiratory Viral Panel (RVP) for BD MAX™ System, a single molecular diagnostic combination test that identifies and distinguishes SARS-CoV-2, influenza A, influenza B, and Respiratory Syncytial Virus (RSV) in approximately two hours.

Key Points: 
  • FRANKLIN LAKES, N.J., Aug. 1, 2023 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Respiratory Viral Panel (RVP) for BD MAX™ System, a single molecular diagnostic combination test that identifies and distinguishes SARS-CoV-2, influenza A, influenza B, and Respiratory Syncytial Virus (RSV) in approximately two hours.
  • The BD RVP test helps eliminate the need for multiple individual tests or doctor visits and can help clinicians implement the right treatment plan quickly.
  • The BD Respiratory Viral Panel for BD MAX™ System was CE marked under the IVD directive 98/79/EC in May of 2022, and now with the 510(k) clearance, BD will discontinue the BD RVP EUA version and replace it with the 510(k) version, with no gaps in availability of the test.
  • The BD MAX™ open system also allows customers to leverage research use only (RUO) assays and user-defined protocols (UDP) to address emerging needs quickly.

Biophytis: Biophytis has requested a pre-submission meeting with the FDA for an Emergency Use Authorization of Sarconeos (BIO101) for the treatment of COVID-19

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목요일, 7월 20, 2023
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Stanislas Veillet, Chief Executive Officer of Biophytis, commented: “We are actively pursuing our roadmap by initiating discussions with the FDA to bring our drug candidate to patients suffering from severe forms of COVID-19 in the United States.

Key Points: 
  • Stanislas Veillet, Chief Executive Officer of Biophytis, commented: “We are actively pursuing our roadmap by initiating discussions with the FDA to bring our drug candidate to patients suffering from severe forms of COVID-19 in the United States.
  • Like influenza, this pathology has become an endemic respiratory infectious disease that can lead to Acute Respiratory Distress Syndrome (ARDS) in elderly, immunocompromised or co-morbid patients.
  • According to the WHO, the medical need remains high, with several thousand deaths per week in the United States and Europe.
  • We look forward to starting discussions with the FDA, and depending on feedback from this agency, we could consider filing an Emergency Use Application by the end of 2023 or in the first half of 2024."

Novavax's Nuvaxovid™ Receives Full Marketing Authorization in the EU for the Prevention of COVID

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목요일, 7월 6, 2023
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Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines .

Key Points: 
  • Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines .
  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
  • Myocarditis, pericarditis, anaphylaxis, paresthesia, and hypoesthesia have been reported following administration of the Novavax COVID-19 Vaccine, Adjuvanted outside of clinical trials.
  • The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.