Infectious Diseases

FDA Approves Bayer’s Lampit for the Treatment of Children with Chagas Disease

WHIPPANY, N.J.–(BUSINESS WIRE)–Bayer announced today that the United States Food and Drug Administration (FDA) has approved Lampit® (nifurtimox) for use in pediatric patients (from birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi (T. cruzi).1 Lampit, …

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Catabasis and Bill & Melinda Gates Medical Research Institute to Study CAT-5571 in Drug-Sensitive and Drug-Resistant Tuberculosis

BOSTON–(BUSINESS WIRE)–Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage biopharmaceutical company, announced today it entered into an agreement with the Bill & Melinda Gates Medical Research Institute (Gates MRI), a non-profit biotechnology organization, to assess CAT-5571 as a potential oral therapy to promote autophagy and clear persistent lung infections in patients with both …

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ImmunityBio Study Shows Positive T Cell and Antibody Immune Responses to its COVID-19 Vaccine Candidate that Targets Both Spike and Nucleocapsid Virus Proteins

CULVER CITY, Calif.–(BUSINESS WIRE)–ImmunityBio, Inc. a privately-held, clinical-stage immunotherapy company, today announced positive preclinical results for its human Ad5 vaccine candidate that contains both the spike (S) and nucleocapsid (N) SARS-CoV-2 proteins (hAd5 S + N) for preventing COVID-19. The results were published in bioRxiv (“A Next Generation Bivalent Human …

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FDA Approves EUA Amendment Increasing Applied DNA’s COVID-19 Diagnostic Kit Testing Capacity

STONY BROOK, N.Y.–(BUSINESS WIRE)–Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables in vitro diagnostics, and pre-clinical nucleic acid-based therapeutic drug candidates, today announced that the U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) …

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Genentech’s Phase 3 Trial of Actemra in Hospitalized Patients With Severe COVID-19 Associated Pneumonia Fails to Meet its Primary Endpoint

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III COVACTA study of Actemra® (tocilizumab) did not meet its primary endpoint of improved clinical status in hospitalized adult patients with severe COVID-19 associated pneumonia. In addition, the key …

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Moderna Announces Expansion of BARDA Agreement to Support Larger Phase 3 Program for Vaccine Against COVID-19

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced a modification to its contract with the Biomedical Advanced Research and Development Authority (BARDA) for an additional commitment of up …

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Pfizer and BioNTech Announce an Agreement with US Government for up to 600 Million Doses of mRNA-based COVID-19 Vaccine Candidate

NEW YORK & MAINZ, Germany–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the execution of an agreement with the U.S. Department of Health and Human Services and the Department of Defense to meet the U.S. government’s Operation Warp Speed program goal to begin delivering 300 million …

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COVID-19 Vaccine AZD1222 Showed Robust Immune Responses in All Participants in Phase I/II Trial

Interim results from the ongoing Phase I/II COV001 trial, led by Oxford University, showed AZD1222 was tolerated and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants. COV001 is a blinded, multi-centre, randomised controlled Phase I/II trial with 1,077 healthy adult participants, aged 18-55 years. It assessed …

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Pfizer and BioNTech Announce Early Positive Update from German Phase 1/2 COVID-19 Vaccine Study, Including First T Cell Response Data

MAINZ, Germany & NEW YORK–(BUSINESS WIRE)–BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) and Pfizer Inc. (NYSE: PFE) today announced initial data from their ongoing German Phase 1/2, open-label, non-randomized, non-placebo-controlled, dose-escalation trial, that is part of the global mRNA-based vaccine program against SARS-CoV-2. The data are available on an online preprint …

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Tonix Pharmaceuticals Announces Research Collaboration to Develop Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

NEW YORK, July 16, 2020 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it has entered into a research collaboration and option agreement with Columbia University focused on studying the immune responses to COVID-19 in healthy volunteers who have …

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