pharmaphorum

DECEMBER 1, 2020

The companies initially filed the nonclinical data and other technical data, followed by emerging clinical trial results. The EMA has also confirmed it has received a filing from Moderna, which is producing a rival vaccine based on similar RNA technology.

Vaccination 88

Vaccination Vaccine RNA Clinical Trials 88

XTalks

NOVEMBER 30, 2023

Over 26 weeks of Sunlenca combined with other antiretroviral drugs, 81 percent of participants achieved HIV RNA suppression, reaching levels low enough to be considered undetectable. Both trials concluded with maintained virologic suppression, and no clinically significant change from baseline in CD4+ cell counts was observed.

FDA Approval 111

FDA Approval Gene Therapy Clinical Trials Clinical Trials 111

pharmaphorum

NOVEMBER 9, 2020

Results will be discussed with regulators worldwide and the European Medicines Agency has already begun its rolling review of data to hasten a decision on the clinical trial dossier. These cause the body to produce antibodies that neutralise the SARS-CoV-2 virus in the event of an infection.

Vaccination 98

Vaccination Vaccine Clinical Trials Clinical Trials 98

The Pharma Data

DECEMBER 8, 2020

Since partnering with Eli Lilly to produce the first monoclonal antibody therapy approved for mild-to-moderate COVID-19 patients, antibody discovery company AbCellera is going big on the Nasdaq. Silverback’s lead candidate is currently in a Phase I trial in adults with HER2-expressing solid tumors. Reduce cost. Nuance Pharma .

RNA 52

RNA Antibody Life Science Protein 52

pharmaphorum

DECEMBER 21, 2020

Their technology is based on synthetic messenger RNA – short for ribose nucleic acid – which is a short transcript of a longer DNA code. As it’s just a messenger molecule, it does not affect the body’s own genetic code when it is injected as a vaccine – but what it does do is instruct cells to code for copies of a certain protein.

Vaccination 111

Vaccination Vaccine Doctors Doctor 111

Worldwide Clinical Trials

MAY 30, 2024

Authors: Rich Worldwide Clinical Trials Exec. This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. Director, Therapeutic Area Medical Lead.

Gene 204

Gene Clinical Trials Clinical Trials Gene Therapy 204

pharmaphorum

OCTOBER 12, 2022

Now, he leads Whitelab Genomics as its artificial intelligence (AI) platform powers the development of genomic therapies – an emerging field in which genetic sequences are injected into cells to target and repair damaged genes. The payload, Del Bourgo tell us, is the therapeutic DNA or RNA sequence that will cure or fix damaged cells.

Genome 105

Genome Genomics Medicine Development 105

The Pharma Data

JANUARY 10, 2021

The new year began with a fairly low level of clinical trial news. Arcturus Therapeutics got the FDA go-ahead for its Phase II trial of its COVID-19 vaccine candidate ARCT-021. The trial will enroll 600 participants, with 450 receiving ARCT-021 and 150 receiving placebo. Here’s a look. COVID-19-Related.

Gene Therapy 52

Gene Therapy Trials Gene Clinical Trials 52

The Pharma Data

JULY 6, 2021

Hemophilia is a rare, genetic bleeding disorder in which a person’s blood does not clot properly. New research will be shared on Cablivi ® (caplacizumab-yhdp), a von Willebrand Factor-directed antibody fragment treatment indicated for use in combination with plasma exchange and immunosuppressive therapy for adult patients with aTTP.

Protein 52

Protein RNA Marketing Development 52

pharmaphorum

DECEMBER 23, 2020

In summer, Alnylam’s gene silencing drug Oxlumo, the first treatment for primary hyperoxaluria type 1 (PH1), an ultra-rare and life-threatening genetic disorder Oxlumo was approved in the European Union and the US. It was the third approval from Alnylam’s pipeline of RNA interference therapeutics to make it to market.

Marketing 96

Marketing Gene Silencing Gene Drugs 96

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. According to the ASGCT, the gene therapy pipeline increased 16% from Q1 2021 with 3,579 gene, cell, and RNA therapies in development from preclinical through pre-registration stages.

Gene Therapy 52

Gene Therapy Gene Manufacturing Medicine 52

Roots Analysis

MAY 21, 2024

LNPs comprise of a lipid bilayer that surrounds a hydrophobic core, which can be loaded with therapeutic agents ( such as drugs, genetic material and proteins ). Several LNP-based therapies are currently being evaluated in the clinical trials; majority of these are conducted for treating breast cancer, ovarian cancer and lung cancer.

Drug Delivery 40

Drug Delivery Drugs Gene Therapy Bioavailability 40

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

pharmaphorum

DECEMBER 13, 2021

Meanwhile, Sanofi also started a first clinical trial of an mRNA-based seasonal flu vaccine in June. The company expects to have two candidates in trials within 12 months and six within the next four years. Dormitzer comes from Pfizer, where he was chief scientific officer for RNA and viral vaccines for more than six years.

RNA 105

RNA Vaccination Vaccine Development 105

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. For more information, visit.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

Delveinsight

AUGUST 6, 2020

The hATTR diagnosis is mainly dependent on symptoms and can be confirmed via performing tissue biopsies, genetic testing, and imaging studies. hATTR Market: Present Treatment Options. Some of the symptomatic therapies available include loop diuretics, aldosterone antagonists, angiotensin-converting enzyme inhibitors, and beta-blockers.

Gene Silencing 52

Gene Silencing Protein Marketing Gene 52

Drug Discovery World

FEBRUARY 6, 2023

A case in point is the emerging omics and other high-throughput laboratory technologies that allow simultaneous profiling of genetic alterations in combination with profiling thousands of molecules in plasma, cell populations, or single cells. Figure 2: Advanced data visualisation examples for transcriptomics data.

Big Data 52

Big Data RNA Bioinformatics Vaccination 52

XTalks

JUNE 5, 2023

RSV belongs to the family of negative-strand RNA viruses and was first identified in 1955. The genetic material of RSV (respiratory syncytial virus) encodes 11 proteins. The Global RSV Vaccine Market Multiple RSV vaccines have received FDA approval or are in advanced stages of clinical trials. How Does Abrysvo Work?

Vaccination 98

Vaccination Vaccine FDA Approval Protein 98

Drug Discovery World

JULY 11, 2023

Now, with the growth of publicly available genomics, transcriptomics, and proteomics databases, the ability to quickly carry out large-scale DNA, RNA, and protein screenings, and the availability of massive sets of de-identified patient data, the amount of high-value, analysable data has reached enormous proportions.

Big Data 40

Big Data Development Life Science Drugs 40

XTalks

OCTOBER 26, 2023

The Flu versus COVID-19: Virology and Vaccines SARS-CoV-2 versus Influenza Virology Viruses contain genetic material that can either be RNA or DNA. Both influenza and SARS-CoV-2 have RNA as their genetic material. An RNA genome enables the genetic material to mutate more rapidly.

Vaccination 105

Vaccination Vaccine RNA Manufacturing 105

The Pharma Data

DECEMBER 27, 2020

Even with the holidays among us, there were a number of clinical trial announcements. Vir Biotechnology and GlaxoSmithKline dosed the first patient in a new sub-trial of a Phase III study of monoclonal antibody VIR-7831 for hospitalized adults with COVID-19. Here’s a look. COVID-19-Related. Non-COVID-19-Related.

Trials 52

Trials Antibody Gene Therapy Clinical Trials 52

XTalks

AUGUST 30, 2022

The webinar also featured Kelsey Carter, MS, Clinical Trial Manager at Medpace who discussed the site, operational and regulatory challenges for neuroscience trials with direct CNS administration along with the strategies to mitigate these challenges. What About Small Proteins and Antibodies Reaching Extracellular CNS Targets?

Trials 83

Trials Drug Delivery Drugs Gene 83

Drug Discovery World

JULY 18, 2023

Incorporating in vivo pooled CRISPR screens has allowed for the interrogation of thousands of genetic perturbations in cells, leading to the determination of the involvement of molecules (PTPN2, ADAR1, or DHX37) in immune checkpoint inhibitor (ICI) responsiveness and T cell activation.

DNA 98

DNA Genome Genomics RNA 98

Drug Discovery World

AUGUST 10, 2022

Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2. Later, scientists took advantage of antibodies’ natural tendency to seek out specific antigens and created antibody therapies that guide T cells towards the cells they are supposed to destroy.

Manufacturing 98

Manufacturing Gene Genome Genomics 98

Delveinsight

AUGUST 5, 2021

Sanofi is betting the genetic technology behind the fast development of two highly effective coronavirus shots last year will result in vaccines for other viruses as well as drugs for diseases of the lung and liver, announcing a deal to acquire a research partner Translate Bio for USD 3.2 Sanofi bets USD 3.2 No financial terms were revealed.

Vaccination 98

Vaccination Vaccine Gene Therapy Development 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. The vaccine produced an immune response of all 805 clinical trial participants within two months of inoculation, according to results published Jan.

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Vaccination Vaccine Trials Immune Response 40

XTalks

DECEMBER 24, 2020

However, for virologists like Lori Frappier, PhD, professor in the department of molecular genetics at the University of Toronto, the outbreak of SARS-CoV-2 was less of a surprise and more of an inevitability. Most antibody drugs and vaccines have been developed to target parts of the spike protein.

Life Science 111

Life Science Vaccination Vaccine Gene 111

Pharmaceutical Technology

APRIL 27, 2023

When combined with rapid advancement in delivery technologies, mRNA has the potential to lead to breakthroughs in the development of tailored treatment approaches in a wide range of indications from cancer to rare genetic disorders while enabling rapid responses to emerging threats. billion by 2028. billion by 2028.

Manufacturing 130

Manufacturing RNA Contamination Vaccination 130

XTalks

SEPTEMBER 14, 2020

By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. The company’s candidate vaccine, mRNA-1273, is a synthetic messenger RNA that encodes the stabilized SARS-CoV-2 spike protein. In older adults, the same vaccine elicited neutralizing antibodies 1.6

Vaccination 92

Vaccination Vaccine Antibody Life Science 92