Infectious Disease

Some alarm appears to be growing amid the rush to develop COVID-19 vaccines, with two prominent critics warning that politics could harm the process. In a New. York Times op-ed this week, Dr. Ezekiel J. Emanuel and Dr. Paul A. Offit of the University of Pennsylvania worried that potential pressure to produce good news for…

Johnson & Johnson (NYSE:JNJ) announced today that its Janssen Pharmaceutical subsidiary has moved up first-in-human clinical trials of its COVID-19 vaccine candidate to late July, versus the previously planned start in September. “Based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities, we have been able to…

New findings from an international research team suggest that neutralizing antibodies could have a use as a preventative treatment or as a post-exposure therapy against COVID-19. Their latest findings, which drew on data gathered from Berkeley National Laboratory’s (Berkeley Lab’s) Advanced Light Source (ALS) — suggest that antibodies derived from SARS survivors could potentially block…

Merck (NYSE:MRK) and IAVI announced today that they are collaborating to develop an investigational vaccine against SARS-CoV-2 for preventing COVID-19. The vaccine candidate is slated to use the recombinant vesicular stomatitis virus (rVSV) technology used as the basis for Merck’s Ervebo Ebola Zaire virus vaccine, which was the first such vaccine to be approved for use…

CRISPR startup Mammoth Biosciences will partner with GlaxoSmithKline’s (NYSE:GSK) consumer healthcare division to develop a home-based diagnostic capable of detecting active SARS-CoV-2, the novel coronavirus that causes COVID-19. The collaboration will use Mammoth Biosciences’ CRISPR-based Detectr  platform to design “guide-RNA” that can identify and signal the presence of viral strands obtained through a simple nasal swab, according to Mammoth…

Octapharma announced today that the FDA approved its investigational new drug (IND) application for a Phase 3 clinical trial for its drug therapy in COVID-19 patients. Octagam 10% [Immune Globulin Intravenous (Human)] therapy will be observed for efficacy and safety in use with COVID-19 patients with severe disease progression, according to a news release. The…

Phlow announced today that it received $354 million in U.S. government funding to manufacture essential medicines at risk of shortage, including those involved in the COVID-19 pandemic response. Richmond, Va.-based Phlow’s manufacturing is being funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the office of Assistant Secretary for Preparedness and Response…

Shortly after touting positive results from its COVID-19 vaccine candidate, Moderna announced the pricing of an offering of 17.6 million shares of its common stock. The Cambridge, Mass.-based clinical-stage biotechnology company announced yesterday that it received positive interim clinical data from trials for its mRNA-1273 vaccine candidate against coronavirus (SARS-CoV-2). Get the full story at our sister site,…

Moderna today touted positive interim clinical data from trials for its mRNA-1273 vaccine candidate against coronavirus (SARS-CoV-2). The Phase I study, led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), recorded positive early results from the first eight people tested, each of whom received two…

BioSig Technologies (Westport, Conn.) said today that its majority-owned ViralClear Pharmaceuticals subsidiary has secured FDA clearance for an Investigational New Drug application to use merimepodib to treat advanced COVID-19 cases. FDA told ViralClear that it may proceed with a phase II trial — a randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of…

Scientists at the La Jolla Institute for Immunology have documented a robust antiviral immune response to SARS-CoV-2 in a group of 20 adults who had recovered from COVID-19. Their work, published in today’s online edition of Cell, show that the body’s immune system is able to recognize SARS-CoV-2 in many ways, dispelling fears that the…

The Biomedical Advanced Research and Development Authority (BARDA) has awarded Selux Diagnostics $9.6 million to fund its development of a next-generation phenotyping (NGP) platform to treat superbug infections and combat antibiotic resistance. The $9.6 million is the third funding tranche the company has received from BARDA as part of the company’s milestone-based contract. BARDA has…

Pfizer and Valneva recently announced that they will collaborate on developing Valneva’s Lyme disease vaccine candidate VLA15, presently in Phase 2 clinical studies. Valneva is eligible to receive a total of $308 million, including $130 million upfront, according to an April 30 news release. Get the full story on our WTWH Media sister site R&D…

Researchers at Sandia National Laboratories are using genetic resequencing tools to find ways to stop the virus behind the COVID-19 pandemic. Biochemist Joe Schoeniger and virologist Oscar Negrete’s work involves genetically engineering a deployable antiviral countermeasure for COVID-19 using CRISPR-based technology. “The goal is to find new ‘reloadable’ countermeasures for viral outbreaks that do not…

International antibodies producer ProteoGenix recently announced what it touts as the first Human Immune COVID-19 library for the fast discovery of potent antibodies against SARS-CoV-2. “Highly sensitive and specific antibodies are critical for the development of diagnostics, therapeutics, and prophylactics to fight against COVID-19,” said Philippe Funfrock, co-founder and president of ProteoGenix. “The new Human…

The FDA this afternoon issued an emergency use authorization for the investigational antiviral drug remdesivir to treat severely ill COVID-19 patients. The authorization for the drug, made by Gilead Sciences’ (NSDQ:GILD), will allow both adults and children to  be treated with the remdesivir, the first drug believed to have any effect on the virus that has sickened…

The National Institutes of Health and its foundation announced that, in collaboration with multiple biopharmaceutical companies and government agencies, they will develop an international strategy for coordinating research responses to the COVID-19 pandemic. The collaboration includes the Health and Human Services Office of the Assistant Secretary for Preparedness and Response, the Centers for Disease Control…

Dr. Anthony Fauci said this morning that hundreds of millions of doses of a vaccine for COVID-19 could be ready by January. In an interview on the Today Show, the director of the National Institute of Allergy and Infectious Diseases said that a vaccine candidate is in the first phase of a clinical trial. If the second…

Johnson & Johnson (NYSE:JNJ) shares dipped today despite first-quarter results that topped the consensus forecast. The New Brunswick, N.J.-based company posted profits of $5.8 billion, or $2.17 per share, on sales of $20.7 billion for the three months ended March 29, 2020, for a 54.6% bottom-line gain on sales growth of 3.3%. Get the full story…

The National Institutes of Health today announced the publishing of new COVID-19 treatment guidelines, and the expert panel producing the guidelines says no drug has yet been proven safe and effective against the virus. NIH has the new guidelines posted online at covid19treatmentguidelines.nih.gov — and says it will update the guidelines often as new peer-reviewed…

Sanofi and GSK recently announced that they have signed a letter of intent to collaborate on an adjuvanted vaccine for COVID-19 — with a goal of having the vaccine available by the second half of 2021. Sanofi is contributing its S-protein COVID-19 antigen. The company’s recombinant DNA technology produced an exact genetic match to proteins…

CRISPR-startup Mammoth Biosciences will file for an emergency use application from the FDA after publishing a study in Nature Biotechnology that suggests its platform can detect SARS-CoV-2 from a respiratory swab RNA extracts in less than 45 minutes. The company says the paper contains the first peer-reviewed data using CRISPR diagnostics for COVID-19. In a…

BioSig Technologies (NSDQ:BSGM) announced today that it is beginning a Phase II clinical trial at Mayo Clinic for Vicromax as a treatment for COVID-19. ViralClear Pharmaceuticals, a subsidiary of BioSig, updated its clinical development program for the Vicromax treatment which is slated to be used in a trial under Dr. Andrew Badley, the professor and chair…

Researchers in Pittsburgh and Boston are moving forward with research into two separate vaccine programs against SARS-CoV-2, the new coronavirus causing the COVID-19 pandemic. The work of the University of Pittsburgh School of Medicine researchers is detailed in a paper published recently in EBioMedicine, which is published by the Lancet. Delivery of the vaccine involved…

While vaccines and pharmaceutical treatments for COVID-19 might be far off, researchers at the Massachusetts Institute of Technology and University of Colorado are exploring a stopgap measure that could buy time for critically ill patients, according to a release by the two institutions. In a clinical trial being planned for hospitals in Massachusetts and Colorado,…