The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

The Pharma Data

DECEMBER 8, 2020

8, 2020 — AstraZeneca’s COVID-19 vaccine is safe and effective, new data from late-stage trials shows. Overall, the vaccine protected against symptomatic disease in 70% of cases, according to a team led by researchers from Oxford University in England. TUESDAY, Dec. 8 in The Lancet.

Vaccine 52

Vaccine Trials Immune Response RNA 52

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.

Vaccine 52

Vaccine Immune Response Virus RNA 52

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. We look forward to vaccinations of this important population starting this week.”. Under Operation Warp Speed, the U.S.

Vaccine 52

Vaccine Long-Term Care Facilities FDA Licensing 52

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. and CHENGDU, China , Feb.

Vaccine 52

Vaccine Trials Virus RNA 52

Broad Institute

JUNE 28, 2023

Today, scientists use these reactions to produce customizable DNA and RNA molecules that enable genetic sequencing, drug and vaccine development, pathogen tests, cancer diagnostics, and many aspects of basic biomedical research. “I Longer synthetic DNA and RNA molecules are also critical for modern biologic drugs.

DNA 98

DNA RNA Science Therapies 98

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. Initial doses are expected to be limited as manufacturing ramps up.

Vaccine 52

Vaccine Immune Response FDA FDA Approval 52

The Pharma Data

MAY 31, 2022

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Takeda ( TSE:4502/NYSE:TAK ) announced to transfer the marketing authorization in Japan for Moderna’s COVID-19 vaccine Spikevax TM (mRNA-1273) from Takeda to Moderna in Japan as of August 1, 2022. Moderna, Inc.,

Vaccine 52

Vaccine Marketing RNA Science 52

The Pharma Data

JANUARY 21, 2021

Because the new COVID-19 vaccines should still work on these viral interlopers. Luckily, the new variants still rely on the coronavirus’ “spike protein” to infect cells, and the two COVID vaccines now on the U.S. Further Support and Information on COVID-19. FRIDAY, Jan. “The spike is really critical.

Vaccine 52

Vaccine Immune Response Virus RNA 52

The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. The interim analysis comprised 95 cases of symptomatic COVID-19 among volunteers.

Clinical Trials 52

Clinical Trials Vaccine Trials FDA Approval 52

The Pharma Data

MARCH 5, 2021

Novartis announced today that it has signed an initial agreement to manufacture the mRNA and bulk drug product for the COVID-19 vaccine candidate CVnCoV from CureVac to aid in the fight against the COVID-19 pandemic. More information about the Novartis response to COVID-19 is available at www.novartis.com/COVID-19.

Vaccine 52

Vaccine Production Biosimilars Hospitals 52

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. We look forward to sharing initial results by year-end. ”. “

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

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.

Immune Response 52

Immune Response Vaccine Virus RNA 52

The Pharma Data

JANUARY 21, 2021

Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said he’s particularly worried about new coronavirus variants that could cause cases to surge and potentially evade the immune protection afforded by COVID-19 vaccines. “That is going to happen quickly.”

Vaccine 52

Vaccine Virus RNA Research 52

The Pharma Data

OCTOBER 25, 2020

We appreciate the confidence of the Ministry of Health of Qatar in our mRNA vaccine platform and the collaboration we have had to date,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We For more information about the COVE study, click here. On Thursday, October 22, Moderna completed enrollment of the Phase 3 COVE study.

Vaccine 52

Vaccine Clinical Development RNA Clinical Trials 52

The Pharma Data

MARCH 11, 2021

Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, today announced the start of the Phase 1/2 clinical trial for MRT5500, an mRNA vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

DECEMBER 18, 2020

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts. The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. SILVER SPRING, Md. , 18, 2020 /PRNewswire/ — Today, the U.S.

Vaccine 52

Vaccine FDA Clinical Trials FDA Approval 52

The Pharma Data

MAY 7, 2021

During an early May meeting, the European Medicines Agency’s safety committee concluded two reviews of safety signals related to COVID-19 vaccines, while it continued following other vaccine-related “topics of interest.” These included reports of heart muscle inflammation after receipt of the Pfizer-BioNTech vaccine. .

Vaccine 40

Vaccine RNA Laboratories Production 40

The Pharma Data

NOVEMBER 16, 2020

We believe that our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our COVID-19 vaccine candidate at temperatures commonly found in readily available pharmaceutical freezers and refrigerators,” said Juan Andres, Chief Technical Operations and Quality Officer at Moderna. “We

Vaccine 52

Vaccine FDA Pharmacy Clinical Trials 52

Broad Institute

JANUARY 30, 2024

Every question that I've chosen to pursue in my lab today is deeply informed by what I’ve seen in the clinic,” he said. "I His talks took a more hopeful tone when the COVID vaccines became a reality. “I Bhattacharyya later helped others at MGH reach out to communities that might not trust messages about the virus and vaccines. “I

Hospitals 137

Hospitals Medical Schools Virus Science 137

Codon

DECEMBER 12, 2024

DNA and RNA molecules are also built from exclusively right-handed nucleic acids. Across the tree of life, organisms strictly require exactly one of the two chiral forms of their molecular building blocks — amino acids, nucleotides of RNA and DNA. 4 As far as we know, right-handed proteins never occur naturally.

DNA 81

DNA RNA Vaccine Virus 81

The Pharma Data

JANUARY 6, 2021

Under the terms of the agreement, Bayer will support the further development, supply and key territory operations of CureVac’s COVID-19 vaccine candidate CVnCoV. “The need for vaccines against COVID-19 is enormous. For more information, go to www.bayer.com. Further information can be found at www.curevac.com.

Vaccine 52

Vaccine Production Marketing RNA 52

The Pharma Data

OCTOBER 23, 2020

The authors recommended viral load thresholds of 1,000 IU for hepatitis B virus (HBV), hepatitis C virus (HCV) RNA undetectable for HCV, and suppressed viral RNA for HIV for determining any restrictions on HCP practice. Career counseling should also be provided for those whose viral loads cannot be consistently suppressed.

RNA 52

RNA Virus Vaccine Treatment 52

Codon

NOVEMBER 3, 2024

Even after microbiologists discovered the bacterium that causes the illness in 1882, it wasn’t until the 1920s that researchers were able to develop a vaccine for TB. These breakthroughs have significantly curbed cases, with vaccination reducing the odds of death by 74 percent. tuberculosis , to develop the vaccine.

Vaccine 85

Vaccine Trials Therapies Treatment 85

Broad Institute

JUNE 28, 2023

Today, scientists use these reactions to produce customizable DNA and RNA molecules that enable genetic sequencing, drug and vaccine development, pathogen tests, cancer diagnostics, and many aspects of basic biomedical research. For more information, visit [link].

DNA 52

DNA RNA Vaccine Research 52

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.

Vaccine 52

Vaccine Clinical Trials FDA Disease 52

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. which spit out information guiding the trimming of tumors in real time, a bit reminiscent of its ancestor Hal the computer from 2001: A Space Odyssey.

Disease 98

Disease DNA Virus RNA 98

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.

Vaccine 40

Vaccine Trials Clinical Trials Immune Response 40

The Pharma Data

DECEMBER 8, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 .–(BUSINESS WIRE)–Dec. 8, 2020– Moderna, Inc.,

Vaccine 40

Vaccine RNA Clinical Trials Government 40

The Pharma Data

OCTOBER 28, 2020

(Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today confirmed that the Ministry of Health, Labour and Welfare of Japan (MHLW) and Takeda Pharmaceutical Co., About Moderna.

Vaccine 40

Vaccine Government Clinical Trials RNA 40

The Pharma Data

NOVEMBER 17, 2020

Moderna’s COVID Vaccine Shows 94.5% announced on Monday that early results show that its coronavirus vaccine is 94.5 The researchers behind the vaccine said the results were better than they had dared to imagine, though it will probably not be available until spring, the Times reported. effectiveness. percent effective.

Vaccine 52

Vaccine Virus RNA Hospitals 52

The Pharma Data

NOVEMBER 18, 2020

” Federal guidelines note that people taking the test should report the results to their health care providers, who must then inform public health authorities to help track the virus’s spread. ” COVID Vaccines Move Closer to Emergency Use Approval. “I am hopeful that it works well.” Meanwhile, Moderna Inc.

FDA Approval 52

FDA Approval FDA Vaccine Virus 52

The Pharma Data

MARCH 8, 2022

The ongoing SARS-CoV-2 pandemic has caused an imminent urge for both antiviral therapeutical drugs and vaccines. While the development of vaccines was accomplished in a remarkably short timeframe, the identification of direct antiviral treatments has progressed comparatively slowly. SARS-CoV-2 belongs to the genus Betacoronavirus.

Clinical Pharmacology 52

Clinical Pharmacology Immune Response RNA Virus 52

The Pharma Data

DECEMBER 31, 2020

Moderna and Pfizer’s COVID-19 Vaccines Roll Out in Early Phase. Food and Drug Administration (FDA) issued Emergency Use Authorization for two COVID-19 vaccines: Pfizer-BioNTech’s BNT162b2 and Moderna’s mRNA-1273. In studies, the vaccines were found to be 94% to 95% effective in preventing COVID-19 disease. Source link.

FDA Approval 52

FDA Approval Vaccine FDA Treatment 52

PLOS: DNA Science

OCTOBER 24, 2024

As days turned to weeks, and the sick lined up outside city hospitals, we craved information. In those early days, politicians and government officials who’d never heard terms like “cytokine storm” and “RNA virus” were suddenly charged with explaining what was happening. On its face it seems legit.

Science 57

Science Research Vaccine Government 57

PerkinElmer

JULY 13, 2020

Sequencing viral genome isolates and creating phylogenetic trees Sequencing a viral genome requires isolating the viral RNA, reverse transcribing it into DNA, and then performing multiple amplification steps using primers. Studying viral mutation is critical for designing effective vaccines, antiviral drugs and diagnostic assays.

Treatment 52

Treatment DNA Virus RNA 52

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.

Engineering 52

Engineering Clinical Research Research Virus 52