Tag: virus

NEW YORK and MAINZ, GERMANY, July 25, 2025 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY^® LP.8.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The adaptation is based on the recommendation from the EMA’s Emergency Task Force (ETF) to update COVID-19 vaccines to target the LP.8.1 variant for the 2025-2026 season. The ETF stated that “targeting LP.8.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve.”²

NEW YORK und MAINZ, Deutschland, 25. Juli 2025 — Pfizer Inc. (NYSE: PFE, „Pfizer“) und BioNTech SE (Nasdaq: BNTX, „BioNTech“) gaben heute bekannt, dass der Ausschuss für Humanarzneimittel (Committee for Medicinal Products for Human Use, „CHMP“) der Europäischen Arzneimittel-Agentur (European Medicines Agency, „EMA“) eine positive Beurteilung für die Marktzulassung (Marketing Authorization) des an LP.8.1 angepassten monovalenten COVID-19-Impfstoffs (COMIRNATY^® LP.8.1) der Unternehmen für die aktive Immunisierung zur Vorbeugung von COVID-19 verursacht durch SARS-CoV-2 bei Personen ab 6 Monaten ausgesprochen hat. Die Anpassung basiert auf der Empfehlung der Notfall-Taskforce (Emergency Task Force, „ETF“) der EMA, die vorschlägt, COVID-19-Impfstoffe zu aktualisieren, um die LP.8.1-Variante für die Impfkampagne 2025-2026 abzudecken. Die Notfall-Taskforce erklärte: „Eine Anpassung an LP.8.1 wird dabei helfen, die Wirksamkeit der Impfstoffe gegen das sich fortlaufend weiterentwickelnde SARS-CoV-2 aufrechtzuerhalten.“² 

Wuppertal, Germany, July 24, 2025 - Aicuris Anti-infective Cures AG today announced the completion of patient enrollment in its pivotal Phase 3 trial, PRIOH-1, evaluating pritelivir for the treatment of refractory and/or treatment resistant herpes simplex virus (HSV) infections in immunocompromised patients. The company’s lead candidate is a small molecule specifically inhibiting the viral helicase-primase complex, which represents a novel mechanism of action distinct from current HSV therapies.

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COPENHAGEN, Denmark, July 22, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that Health Canada has accepted for review the Company’s application for licensure of the single-dose, virus-like particle (VLP) chikungunya vaccine candidate, CHIKV VLP, for immunization to prevent disease caused by chikungunya virus infection in individuals 12 years of age and older. The application screening acceptance by the Directorate confirms that the New Drug Submission is complete and begins a standard review procedure, potentially supporting approval of the vaccine in the first half of 2026.

KØBENHAVN, Danmark, 22. juli 2025 – Bavarian Nordic A/S (OMX: BAVA) offentliggjorde i dag, at de canadiske lægemiddelmyndigheder, Health Canada, har accepteret selskabets ansøgning om markedsføringstilladelse for den virus-lignende partikel (VLP)-baserede, enkelt-dosis chikungunyavaccinekandidat, CHIKV VLP, til forebyggelse af sygdom forårsaget af chikungunyavirus hos personer på 12 år og ældre. Dermed starter myndighedernes standardgennemgang, hvilket potentielt understøtter godkendelse af vaccinen i første halvår 2026.

NEW YORK and VIENNA, July 18, 2025 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, “HOOKIPA”), a clinical-stage biopharmaceutical company developing next-generation immunotherapeutics for the treatment of cancer and serious infectious diseases, today announced its intention to voluntarily delist from the Nasdaq Capital Market (“Nasdaq”) and to deregister its common stock under Section 12(b) and Section 12(g) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and suspend its reporting obligations under Section 15(d) of the Exchange Act.