Infectious Disease

Antivirals have several advantages over vaccines. They tend to be broadly effective against viral variants and offer faster-acting protection than vaccines. In addition, antivirals are usually simple to transport and don’t require ultra-cold storage. And oral antivirals would have an advantage in terms of the speed of protection they offer. For SARS-CoV-2, antivirals also could…

Johnson & Johnson’s Janssen division (NYSE:JNJ) has requested that FDA expand the emergency use authorization (EUA) for its Ad26.COV2.S COVID-19 vaccine to include boosters for people 18 and older. The previous EUA covered a single dose of the vaccine. On October 14 and 15, FDA will convene meetings of its Vaccines and Related Biological Products…

The antiviral molnupiravir appears to be destined to become the first oral treatment for COVID-19. Merck and its partner Ridgeback Biotherapeutics intend to file for emergency use authorization after announcing that the drug appears to reduce the risk of hospitalization or death by about 50%. One potential hurdle for the drug is whether unvaccinated individuals…

The oral antiviral molnupiravir from Merck (NYSE:MRK) and Ridgeback Biotherapeutics fared well in a planned interim analysis of the Phase 3 MOVe-OUT trial. If authorized by FDA, the pill would be the first oral antiviral for SARS-CoV-2 in the U.S. To date, all authorized or approved COVID-19 drugs require subcutaneous, intramuscular or intravenous administration. Merck…

Regeneron Pharmaceuticals (NSDQ:REGN) and Roche (OTCQX: RHHBY) are touting positive results from a Phase 2/3 study investigating the potential of REGEN-COV (casirivimab and imdevimab) antibody cocktail in hospitalized COVID-19 patients. The study met its primary endpoint of reducing viral load within one week in seronegative patients needing low-flow or no supplemental oxygen. REGEN-COV, known as…

The FDA could authorize the use of Moderna (NSDQ:MRNA) COVID-19 vaccine boosters at a half-dose level, according to a report from Bloomberg. Each primary series dose of the Moderna vaccine contains 100 µg of mRNA. By contrast, the Pfizer-BioNTech vaccine uses a 30-µg dose level for the primary series and boosters. Earlier this month, Moderna CEO…

After recently sharing positive Phase 2b data related to its experimental respiratory syncytial virus (RSV) vaccine in seniors, Janssen (NYSE: JNJ) has launched a Phase 3 study of the vaccine.  RSV is common and contributes to serious respiratory illnesses, including pneumonia in the elderly. The virus infects approximately 64 million people annually.  The global EVERGREEN…

Most third doses of mRNA COVID-19 vaccines elicit side effects in line with that of the second dose, according to a CDC report. The study analyzed immunocompromised recipients of the Pfizer-BioNTech and Moderna COVID-19 vaccine recipients eligible for a third dose. It pulled data from 22,191 V-safe registrations. V-safe is a CDC-created smartphone-based system for tracking…

After two senior FDA officials announced their intent to retire, CBER director Dr. Peter Marks will take the reins of the agency’s Office of Vaccines Research and Review. Marks assumed the role of acting director of the office on Monday. The departing officials, director of the FDA’s Office of Vaccines Research and Review Dr. Marion…

Privately-held BioAegis Therapeutics has announced that researchers have identified a previously unknown role of the protein gelsolin in regulating immune responses. BioAegis’s therapeutic focus is to restore waning gelsolin levels associated with disease. In a paper published in The Journal of Immunology, researchers reported that the gelsolin is involved in a signaling system in macrophages, which…

Pfizer (NYSE:PFE) and BioNTech (NSDQ: BNTX) plan to formally seek FDA emergency authorization in the coming weeks for the use of their Comirnaty (BNT162b2) vaccine in children 5 to 11. The news came today as the companies announced the submission of initial Phase 2/3 trial data to FDA. The companies last week announced that the…

Antibiotic specialist Paratek Pharmaceuticals (NSDQ: PRTK) has secured additional funding from the Biomedical Advanced Research and Development Authority (BARDA) to develop the antibiotic Nuzyra (omadacycline) for anthrax. Specifically, the latest funding will support Paratek’s program to develop the tetracycline-class antibiotic Nuzyra as a post-exposure prophylaxis and pulmonary anthrax treatment. The latest BARDA funding will support…

Pfizer (NYSE:PFE) has announced the launch of the Phase 2/3 EPIC-PEP study to test its oral antiviral candidate PF-07321332 as a post-exposure prophylaxis against COVID-19. The EPIC-PEP study, whose name is an acronym of “Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis,” will test the efficacy of PF-07321332 with low-dose ritonavir to prevent COVID-19…

Antibiotic specialist Paratek Pharmaceuticals (NSDQ:PRTK) recently shared new data related to its tetracycline-class antibacterial Nuzyra (omadacycline). Specifically, the company provided real-world data related to pneumonia, skin infections and nontuberculous mycobacterial infections in presentations at IDWeek 2021, a virtual conference organized by several infectious disease associations. The company also has collected data on in vitro activity…

In an interview with the German-language Neue Zürcher Zeitung, Moderna leader Stéphane Bancel shared his predictions about the course of the pandemic. When asked when the pandemic phase would end, Bancel replied: “As of today, I assume in one year.” Seniors will need yearly COVID-19 boosters, Bancel said, while the rest of the public will benefit…

The emerging biotech Gritstone Bio (NSDQ:GRTS) has dosed the first patient with its second-generation COVID-19 vaccine known as GRT-R910. The University of Manchester and Manchester University NHS Foundation Trust are jointly overseeing the U.K.-based Phase 1 study. The GRT-R910 vaccine uses self-amplifying mRNA (SAM), which could optimize antigen expression at lower doses relative to conventional…

Pardes Biosciences, a biopharma upstart based in Carlsbad, California, has announced that the U.S. Patent and Trademark Office has issued a new patent No. 11,124,497. The patent relates to compounds intended to inhibit the main protease (Mpro) of SARS-CoV-2.   “This issued patent is the first from our growing IP portfolio and reflects our commitment to…

A handful of companies are making billions of dollars in revenues from COVID-19 vaccines. Especially well-positioned is Pfizer, which could earn $33.5 billion in COVID-19 vaccine sales this year, as it announced in its Q2 earnings statement. By contrast, J&J has forecasted $2.5 billion in COVID-19 vaccine sales this year, while AstraZeneca has seen sales of…

The Global Institute of Stem Cell Therapy and Research (GIOSTAR) has announced that the FDA has authorized emergency use of its stem cell therapy for hospitalized COVID-19 patients. The San Diego–based organization has offered stem cell therapy for COVID-19-related symptoms since April 2020. “Stem cell therapy is at the forefront of the fight against COVID-19…

CDC today released comparative effectiveness data for the three COVID-19 vaccines available in the U.S. in individuals without immunocompromising conditions. The study also found that protection from the Pfizer-BioNTech vaccine dipped four months after vaccination to 77%. The effectiveness of the Moderna vaccine at that interval was 92%. The CDC also concluded that, from March 11…

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously supported emergency use authorization to administer the Pfizer-BioNTech Comirnaty vaccine as a booster to those 65 years of age and older, and individuals at high risk of developing severe COVID-19. The panel, however, resoundingly rejected a plan to administer the vaccine as a booster to…

FDA has expanded the emergency use authorization for Lilly’s (NYSE:LLY) bamlanivimab and etesevimab combo to include post-exposure prophylaxis. Earlier in the year, federal authorities had counseled against the use of the  monoclonal antibody cocktail in several states given the rise of SARS-CoV-2 variants in the U.S., including Gamma (P.1) and Beta (B.1.351). Meanwhile, demand for…

Facing the second-biggest wave of COVID-19 infections and waning popularity, President Biden has promised to launch an initiative to begin providing vaccine boosters starting September 20.  But the plan hinges upon FDA and CDC support, and some officials at the agencies remain unconvinced that boosters are immediately necessary.  Two departing senior FDA vaccine officials recently co-wrote…

Sanofi (NSDQ:SNY) announced today that it has completed the purchase of its mRNA partner Translate Bio. The previously announced deal, according to Sanofi, accelerates the French pharma giant’s efforts to develop transformative vaccines and therapies using mRNA technology. The deal comes during a year in which mRNA-based Moderna (NSDQ:MRNA) and Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) COVID-19 vaccines are…

FDA leaders have issued a statement regarding the agency’s plan for authorizing COVID-19 vaccines for children. The FDA plans to “follow the science” with eyes on COVID-19 vaccines for children younger than 12 as schools begin to get back in session around the country, the agency said in a news release attributed to acting Commissioner…