The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif.

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The Pharma Data

JANUARY 11, 2021

Moderna is following up on the success of its messenger RNA-based COVID-19 vaccine with plans to develop inoculations for numerous other infectious diseases, the company said Monday. based company has been in business for 10 years, but the COVID-19 vaccine was its first approved product. 18, 2020 ). It has already received $2.8

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The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. “Our About the Phase 1/2 clinical trial.

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Drug Discovery World

JANUARY 21, 2024

As a vaccine immunologist Kanekiyo’s primary research interests are structure-based vaccine design, viral immunity, and host-pathogen interplay. As a vaccine immunologist Kanekiyo’s primary research interests are structure-based vaccine design, viral immunity, and host-pathogen interplay.

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The Pharma Data

DECEMBER 3, 2020

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. No serious adverse events related to the vaccine candidates studied were reported.

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The Pharma Data

AUGUST 16, 2021

The study assessed cynomolgus macaques vaccinated with 12µg of either the first or second-generation vaccine candidate. During challenge with the original SARS-CoV-2 virus, animals vaccinated with CV2CoV were found to be better protected based on highly effective clearance of the virus in the lungs and nasal passages.

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The Pharma Data

DECEMBER 16, 2020

Food and Drug Administration (FDA) advisory panel in regard to the COVID-19 vaccine from Moderna. The Vaccines and Related Biological Products Advisory Committee will be determining whether the product should be authorized for emergency use, according to CNBC. The vote itself is not slated to take place until after 3 p.m.

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The Pharma Data

JANUARY 22, 2021

As research developments into RNA vaccines help scientists accelerate drug candidates to arm the immune system against coronavirus, Pharma IQ ’s Keeping tabs on Covid-19 update returns with news from some of the biotechnology innovators leading the fight against the global pandemic.

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The Pharma Data

AUGUST 16, 2021

The antiviral agent incorporates RNA-like building blocks into the RNA genome of the virus. If this genetic material is further replicated, defective RNA copies are produced and the pathogen can no longer spread. Molnupiravir is currently being tested in clinical trials.

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The Pharma Data

MAY 17, 2021

Sanofi and GlaxoSmithKline (GSK) have reemerged as COVID-19 vaccine contenders after their reformulated candidate delivered a strong immune response across all age groups in a phase 2 study. Sanofi and GSK now plan to enroll more than 35,000 participants I a phase 3 study to evaluate the vaccine’s efficacy against the original SARS?CoV?2

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The Pharma Data

DECEMBER 10, 2020

–( BUSINESS WIRE )– ImmunityBio , a privately-held immunotherapy company, today announced its COVID-19 vaccine candidate protected nasal and lung airways of non-human primates against coronavirus (SARS-CoV-2) in a challenge study. 11, 2020 02:48 UTC. CULVER CITY, Calif.–( This press release features multimedia.

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The Pharma Data

DECEMBER 19, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. 11 ACIP members voted in favor of the vaccine and 0 members voted against. Healthcare workers have been on the front lines of the fight against the virus and are an inspiration to us all.

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The Pharma Data

DECEMBER 3, 2020

The Pfizer – BioNTech and Moderna ’s COVID-19 vaccines are currently being reviewed for possible Emergency Use Authorization (EUA) by the U.S. On Tuesday, the Pfizer-BioNTech vaccine was granted temporary authorization in the UK and dosing will begin next week. Pfizer gets its raw materials for the vaccine from the U.S.

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The Pharma Data

DECEMBER 18, 2020

Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. Hahn , M.D.

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Advarra

MARCH 31, 2023

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. Gene Delivery Systems Genetic material, in the form of DNA or RNA, does not easily enter cells without the aid of a delivery system.

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The Pharma Data

SEPTEMBER 1, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the initiation of the Phase 3 MOVe-AHEAD clinical trial to evaluate molnupiravir, an investigational oral antiviral therapeutic, for the prevention of COVID-19 infection.

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The Pharma Data

NOVEMBER 16, 2020

The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. The majority of adverse events were mild or moderate in severity.

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NIH Director's Blog: Drug Development

NOVEMBER 16, 2021

That progress includes the development of life-preserving monoclonal antibody infusions and repurposing existing drugs , to which NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV ) public-private partnership has made a major contribution. But would it work to treat COVID-19 in an infected person?

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The Pharma Data

NOVEMBER 18, 2020

The California company said that clinical trials showed 100% of patients were able to perform the Lucira test in about two minutes. Lab tests that look for the coronavirus’s genetic material using a technique called polymerase chain reaction (PCR) are still considered the gold standard for detecting the virus.

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Drug Discovery World

SEPTEMBER 6, 2022

And whilst clinical trials activity decreased by around 15% compared to 2020, last year still saw a number of regenerative medicines reach the bedside. Thompson says that the development of Covid-19 vaccines, which used mRNA technology, resulted in wider acceptance for cell and gene therapies. . “On billion, compared to $19.9

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The Pharma Data

NOVEMBER 17, 2020

After getting the virus under control, California Gov. Until now, Reynolds had ignored infectious disease experts who say masks are one of the most effective tools to control the spread of the virus, the Post reported. Moderna’s COVID Vaccine Shows 94.5% effectiveness. In some good news, Moderna Inc. percent effective.

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Drug Discovery World

APRIL 30, 2024

Messenger RNA (mRNA) has come into focus within the drug discovery and development as an exciting tool to deliver genetic information. mRNA is a molecule made up of a single strand of ribonucleic acid (RNA). Reece Armstrong explores the potential and future opportunities for mRNA-based therapies.

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PLOS: DNA Science

JULY 27, 2023

That information led, thanks to vaccine shelved from the first SARS circa 2003, to the rapid development and deployment of mRNA vaccines against the new infectious disease. The owners of the felines all reported feeding their pets raw meat, and samples of the meat revealed not only flu virus genetic material, but also infectious virus.

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Drug Discovery World

OCTOBER 4, 2022

The pandemic might have affected the number of clinical trials taking place for cell and gene therapies, with activity decreasing by around 15% compared to 2020, but major therapies such as Novartis’ gene therapy drug for spinal muscular atrophy (SMA) Zolgensma still made it to market. .

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Drug Discovery World

AUGUST 1, 2023

1 August was first chosen as World RNA Day in 2018 as a play on AUG (adenine, uracil and guanine), a triple sequence of RNA (called a codon) that initiates protein synthesis by the cell. Since then, it has been observed to publicise the importance of this molecule in the generation of proteins in the body.

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PerkinElmer

AUGUST 18, 2020

This is especially applicable to labs involved in the development of highly sought-after viral therapeutics and vaccines. The time sensitivity of virus research, combined with an increasing complexity of bench tasks, can make it helpful for labs to increase automaticity of experiments.

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NIH Director's Blog: Drug Development

JANUARY 5, 2016

This gene-editing system consists of a short segment of RNA that is attached to an enzyme. The RNA is preprogrammed to find a distinct short sequence of DNA and deliver the enzyme, which acts like a scalpel to slice the sequence out of the genome. 3] A Recombinant Vesicular Stomatitis Virus Ebola Vaccine — Preliminary Report.

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The Pharma Data

SEPTEMBER 8, 2020

Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.

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The Pharma Data

SEPTEMBER 8, 2020

— Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.

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Codon

APRIL 30, 2023

Also, last week’s digest had an error: The country that approved the malaria vaccine was Ghana. Vaccines (basically little fat bubbles filled with mRNA and some dissolvable polymers) were physically printed onto microneedle patches using a robot. The patches have little spikes that help push the vaccines through the skin.

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Codon

APRIL 30, 2023

Also, last week’s digest had an error: The country that approved the malaria vaccine was Ghana. Vaccines (basically little fat bubbles filled with mRNA and some dissolvable polymers) were physically printed onto microneedle patches using a robot. The patches have little spikes that help push the vaccines through the skin.

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The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021.

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The Pharma Data

JUNE 25, 2021

In the unprecedented context of at least 13 variants circulating within the study population subset assessed at this interim analysis, CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. 37, first identified in Peru (21%) and B.1.621,

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The Pharma Data

JULY 29, 2021

Hepatitis B virus (“HBV”) and hepatitis delta virus (“HDV”) product sales increased 8% to $237 million for the second quarter 2021 compared to the same period in 2020. Sales of Veklury are generally affected by COVID-19 related rates of infections, hospitalizations and vaccinations. Total second quarter 2021 revenue of $6.2

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The Pharma Data

SEPTEMBER 9, 2020

Immunization of non-human primates (rhesus macaques) with BNT162b2, a nucleoside-modified messenger RNA (modRNA) candidate that expresses the SARS-CoV-2 spike glycoprotein, resulted in strong anti-viral effects against an infectious SARS-CoV-2 challenge. Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We

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Codon

MARCH 20, 2023

Basic Science A trailing ribosome speeds up RNA polymerase at the expense of transcript fidelity via force and allostery. Ribozyme-mediated RNA synthesis and replication in a model Hadean microenvironment. Assembly of metabolons in yeast using Cas6-mediated RNA scaffolding. elegans neurons for single-cell RNA sequencing.

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The Pharma Data

JANUARY 13, 2021

13, 2021 — A single-shot COVID-19 vaccine from Johnson & Johnson has shown very strong results in early clinical trials, potentially providing a significant boost to U.S. vaccination efforts. The new vaccine remains stable for a time in the refrigerator. WEDNESDAY, Jan. 13 in the New England Journal of Medicine.

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