Tag: vaccines

Biotech, Industry

Genetic Engineering Across the Tree of Life

September 21, 2020

Via: Genetic Engineering and Biotechnology News

Industrial bioengineering is now using genetically modified microbes to produce a wide array of products at industrial scale, including everything from biofuels to nutraceuticals such as resveratrol. But despite the diversity of output, the primary organisms producing them are modified […]

Industry, Vaccines

Moderna says it will begin developing a vaccine for seasonal flu

September 17, 2020


Biotech firm Moderna said Thursday it will begin developing a vaccine for the influenza season. “We are announcing that we are increasing our investment in vaccines and we will develop a seasonal flu vaccine given the unmet need for highly […]

FDA, Regulations

FDA Clears IND Application for Vaxart Oral COVID-19 Vaccine

September 16, 2020

Via: Contract Pharma

The U.S. Food and Drug Administration (FDA) has completed its review of Vaxart Inc.’s Investigational New Drug (IND) application for its Phase 1 clinical trial evaluating its oral COVID-19 vaccine candidate. “Our goal is to deliver the best, most elegant […]

FDA, News, Regulations

Trump health officials prepare to distribute coronavirus vaccine within 24 hours of OK from FDA

September 16, 2020


The U.S. government plans to transport a coronavirus vaccine to distribution sites across the U.S. within 24 hours after the Food and Drug Administration grants an emergency authorization or approval, senior administration officials said Wednesday. The government will use medical […]

Industry, Vaccines

Automation a Key Focus for Moderna’s COVID-19 Vaccine Contractor

September 15, 2020

Via: Genetic Engineering and Biotechnology News

Moderna hired Lonza to make its COVID-19 vaccine in May. Initially, the CDMO will manufacture the vaccine active ingredient—an mRNA molecule in lipid nanoparticles—at plants in the United States and Switzerland. However, the firms plan to establish additional production suites […]

Clinical Trials, Research and Development

Protein Identified for New Hearing Hair Cell Development

September 14, 2020

Via: Genetic Engineering and Biotechnology News

Scientists at the University of Maryland School of Medicine (UMSOM) say they have conducted a study that has determined the role that a critical protein plays in the development of hair cells which are vital for hearing. Some of these […]

FDA, News, Pricing, Regulations

Democratic senators grill U.S. health officials on Trump interference in coronavirus vaccine process

September 9, 2020


Democratic senators on Wednesday grilled U.S. health officials about whether President Donald Trump is interfering in the development of potential coronavirus vaccines. National Institutes of Health Director Dr. Francis Collins and U.S. Surgeon General Dr. Jerome Adams testified before the […]

FDA, Industry, Regulations, Vaccines

FDA Clears SPI’s Ebselen for Phase II COVID-19 Trials

August 31, 2020

Via: Contract Pharma

Sound Pharmaceuticals, Inc. (SPI) received clearance from the FDA to begin two Phase 2 studies of ebselen (SPI-1005) in COVID-19 patients. SPI-1005 is a novel anti-inflammatory drug which was recently shown to inhibit nCoV2 activity and viral replication. The two […]

Industry, Vaccines

AstraZeneca nets $396M down payment from EU for 300M-plus COVID vaccines

August 28, 2020

Via: FiercePharma

AstraZeneca has been on roll lately, inking COVID-19 vaccine supply deals left and right with countries worldwide. One of its highest-profile pacts—a purchase deal with the European Union—was made official earlier this month, and now, the trading bloc has floated […]

FDA, Regulations

Trump accuses FDA of playing politics with last-minute COVID-19 plasma delay

August 20, 2020

Via: FierceBiotech

As the months tick down before the November election, President Donald Trump is seemingly under increasing pressure to find vaccines and treatments for COVID-19. He has touted several unproved drugs as being potentially beneficial and, in recent weeks, has talked […]

Industry, Manufacturing, Research and Development, Vaccines

Therapure Signs Manufacturing Deal with VBI Vaccines

August 18, 2020

Via: Contract Pharma

Therapure Biomanufacturing, a division of Therapure Biopharma Inc., has signed an agreement with VBI Vaccines Inc. for the manufacture of their coronavirus vaccine candidates. Therapure Biomanufacturing is an integrated contract development and manufacturing organization (CDMO) focused on biologic and high […]

Industry, Vaccines

WHO warns against coronavirus ‘vaccine nationalism and risk of price gouging’

August 13, 2020


High demand for a safe and effective vaccine against the coronavirus is already causing competition between countries and could drive prices higher, the World Health Organization’s top official warned Thursday. “When a successful new vaccine is found, there will be […]