pharmaphorum

DECEMBER 23, 2021

The US regulator issued Novartis with a complete response letter (CRL) for inclisiran a year ago, citing “unresolved facility inspection-related conditions” at a third-party manufacturing site run by Corden Pharma near Milan, Italy. It will be launched in the US in January, said Novartis.

Drugs 104

Drugs Sales Antibody FDA Approval 104

pharmaphorum

NOVEMBER 17, 2020

Pfizer is poised to file the vaccine with the FDA in the coming days, seeking an Emergency Use Authorization (EUA) after gathering enough safety data required by the regulator. Both Pfizer and Moderna vaccines use synthetic messenger RNA to activate the immune system against the virus. Pfizer and BioNTech have a $1.95

Vaccination 75

Vaccination Vaccine RNA Clinical Trials 75

pharmaphorum

MARCH 9, 2022

Sanofi and Sobi’s haemophilia partnership has been under competitive pressure from new therapies like Roche’s antibody Hemlibra, so the two companies are hoping a new long-acting drug candidate can revitalise the franchise.

Protein 98

Protein Sales Gene Therapy Regulation 98

pharmaphorum

JANUARY 5, 2022

The results of the CORAL-BOOST are only in a few patients, but showed strong increases in neutralising antibody levels when Gritstone’s shot given as a booster after two doses of AstraZeneca’s Vaxzevria given as a primary course. “With new variants – like Omicron and B.1.640.2

Protein 125

Protein Vaccination Vaccine Immune Response 125

pharmaphorum

OCTOBER 6, 2020

The announcement comes just days after the regulator said its CHMP scientific committee had begun to look at the first batch of data from AZ’s rival. These studies suggest BNT162b2 triggers the production of neutralising antibodies and T-cells that target SARS-CoV-2, the coronavirus that causes COVID-19.

Vaccination 57

Vaccination Vaccine RNA Immune Response 57

pharmaphorum

FEBRUARY 9, 2021

InteRNA is focusing on the development of gene-silencing drugs based on microRNA, naturally occurring, non-coding strands of RNA that are thought to regulate gene expression in cells.

Trials 57

Trials Gene Silencing RNA Gene Expression 57

Roots Analysis

OCTOBER 30, 2023

In the past few years, Next Generation RNA therapeutics have emerged as one of the key therapeutic modalities in the modern healthcare industry. These RNA based therapeutics play a crucial role in protein production and regulation of gene functions.

RNA 40

RNA Vaccination Vaccine Development 40

The Pharma Data

MAY 17, 2021

But the companies said their refined antigen formulation induced a strong immune response in individuals agesd18 to 95, with neutralizing antibodies comparable to those found in patients after recovery from SARS?CoV?2 And if the results are positive, the companies expect to seek approval from regulators in the fourth quarter.

Vaccination 40

Vaccination Vaccine Immune Response RNA 40

pharmaphorum

JULY 19, 2021

Drugs harnessing the potential of modified RNA, antisense and siRNA oligonucleotides, antibody–drug conjugates and nanomedicines will become as important as today’s ‘small molecule’ drugs, reaching potential market values into the hundreds of billions – if the potential can be realised through innovation support and industry collaboration.

Life Science 52

Life Science Medicine RNA Vaccination 52

pharmaphorum

OCTOBER 22, 2020

AT-527 works by blocking the viral RNA polymerase enzyme needed for viral replication. But the findings of the latest phase 3 study , EMPACTA, could change that after Roche said it plans to share results with the FDA and other regulators to get its label expanded on the basis of the latest results.

Development 65

Development Branding Manufacturing RNA 65

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

pharmaphorum

JANUARY 20, 2021

The variant that originated in South Africa carries a mutation in the Spike protein that has been shown to reduce antibody recognition and could therefore affect efficacy of new vaccines. These will be encoded in messenger RNA (mRNA) formulated with the laboratory’s NLP technology before injection.

Vaccination 52

Vaccination Vaccine Protein RNA 52

The Pharma Data

MAY 7, 2021

Despite PRAC’s ongoing surveillance and review, no safety signal is being found for the low platelet and clotting syndrome with either of the two authorized messenger RNA (mRNA) vaccines. The regulator has asked AstraZeneca for a detailed analysis of these cases when the firm submits its next required monthly safety report. .

Vaccination 52

Vaccination Vaccine Filler Antibody 52

pharmaphorum

JULY 21, 2021

Novartis has revealed that the FDA has accepted its resubmission for cholesterol-lowering drug Leqvio – rejected unexpectedly by the US regulator last year – and has set a new action date of 1 January 2022.

Sales 52

Sales Gene Therapy RNA Production 52

Roots Analysis

OCTOBER 22, 2023

RNA therapeutics are a novel class of biopharmaceuticals that harness the power of RNA molecules for the treatment and prevention of a wide range of disorders, including oncological, and genetic disorders as well as infectious diseases. Non-coding RNAs include antisense oligonucleotides (ASOs) and RNA aptamers.

RNA 40

RNA Protein Genetics Gene Expression 40

pharmaphorum

JANUARY 5, 2022

New oral therapies join the existing monoclonal antibody cocktails and include molnupiravir (Lagevrio, Merck) and a combination of the new antiviral nirmatrelvir with the HIV antiviral ritonavir (Paxlovid, Pfizer). New COVID-19 treatments will also be available in 2022, but they are not a panacea.

Vaccination 98

Vaccination Vaccine Antibody FDA Approval 98

pharmaphorum

DECEMBER 21, 2020

But the tragic events of 2020 have meant these companies have become household names as their trailblazing mRNA vaccines became the first to be approved by regulators against the COVID-19 scourge. Their technology is based on synthetic messenger RNA – short for ribose nucleic acid – which is a short transcript of a longer DNA code.

Vaccination 109

Vaccination Vaccine Doctors Doctor 109

XTalks

NOVEMBER 7, 2022

Another method to isolate CTCs is by antibody targeting of white blood cells for removal, followed by collection of untagged CTCs. Also, exosomes are mostly being used for the detection of circulating RNA and microRNA. “An Regulators may ask at some point to provide that documentation, so it’s important to track that across the study.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

Pharmaceutical Technology

FEBRUARY 1, 2023

AstraZeneca’s Synagis (palivizumab), which was approved in 1998, was the only monoclonal antibody (mAb) available for use to prevent RSV in high-risk infants for the past two decades. As an RNA virus, like SARS-CoV-2, RSV is highly prone to mutations.

Vaccination 162

Vaccination Vaccine Antibody Protein 162

pharmaphorum

APRIL 28, 2022

Additionally, regulators recognise the inherent difficulties of finding sufficient populations to study rare diseases, so requirements for clinical rigour can actually be lighter, which can also lead to savings. But they also don’t have to invest in mass market advertising.

Pharma Companies 57

Pharma Companies Branding Development Marketing 57

Drug Discovery World

JUNE 27, 2023

Scientists from Japan have identified regulator CD69, which controls the differentiation of CD8+ T cells within tumour-draining lymph nodes, thereby regulating anti-tumour immunity. CD8+ T cells have been the focal point of anti-cancer therapies.

Regulation 52

Regulation Antibody Scientist Immune Response 52

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

The Pharma Data

AUGUST 3, 2021

Revenue growth was 12 percent when excluding effects of 2020 COVID-related stocking patterns, revenue from COVID-19 antibodies and recent business development. million in the second quarter of 2021 for its COVID-19 antibodies. million of revenue in the second quarter of 2021 from COVID-19 antibodies, $170.0 Excluding $148.9

Antibody 52

Antibody Sales Development Production 52

Drug Discovery World

NOVEMBER 13, 2023

Ahead of protein and antibody engineering conference PEGS Europe 2024 in Lisbon, DDW’s Megan Thomas looks at what to expect from each track of the annual biologics technology meeting. Hiroki Shirai, PhD, Coordinator, RIKEN Center for Computational Science, on: ‘Applying deep learning anomaly detection to antibody structures’.

Protein 59

Protein Antibody Engineer Scientist 59

The Pharma Data

JANUARY 6, 2021

About CureVac CureVac is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing and optimizing the versatile biological molecule for medical purposes. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros.

Vaccination 52

Vaccination Vaccine Development Marketing 52

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

The Pharma Data

JANUARY 21, 2021

” But the Pfizer and Moderna vaccines are designed to not only target the spike protein, but to promote the creation of antibodies that will attack it in several different ways, Salvatore said. “The height of the antibody response may be somewhat proportional to how sick you are in the beginning.

Vaccination 52

Vaccination Vaccine Protein Immune Response 52

Drug Discovery World

JULY 18, 2023

Current research is focused on designing CRISPR-enhanced CAR T cells that are resistant to immunosuppressive cytokines such as transforming growth factor-β (TGF-β) 2 , programmed cell death protein (PD-1) 3 , or other negative T cell regulators 4 (CTLA-4, LAG-3, and TIM-3), thus improving anti-tumour functions.

DNA 98

DNA Genome Genomics RNA 98

The Pharma Data

SEPTEMBER 8, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

SEPTEMBER 8, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. For more information, visit. www.merck.com. and connect with us on. the United States.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

XTalks

AUGUST 2, 2023

2) Darzalex (daratumumab) Darzalex is a targeted monoclonal antibody that slows or stops the progression of multiple myeloma (a blood cancer) by binding to the CD38 protein on multiple myeloma cells. In September 2022, Roche acquired Good Therapeutics for an upfront payment of $250 million, and has access to their PD-1-regulated IL-2 program.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

XTalks

AUGUST 30, 2022

Such therapies may involve small interfering RNA (siRNA) or oligonucleotides in viral transfection platforms, large molecules and antibodies. What About Small Proteins and Antibodies Reaching Extracellular CNS Targets? Vornov, nusinersen is driving much of what is being currently seen in drug development.

Trials 83

Trials Drug Delivery Drugs Gene 83

Drug Discovery World

APRIL 12, 2023

According to a McKinsey & Company article 2 , new drug modalities (such as RNA therapeutics, protein degraders, cyclopeptides, ADCs, cell and gene therapies) have almost doubled from 11% to 21% of the drug pipeline. For some pharmaceutical companies, like AstraZeneca 3 , 30% of their early pipeline consists of new drug modalities.

Development 52

Development In-Vivo Drugs In-Vitro 52

Drug Discovery World

JANUARY 20, 2023

According to a McKinsey & Company article 2 , new drug modalities (such as RNA therapeutics, protein degraders, cyclopeptides, ADCs, cell and gene therapies) have almost doubled from 11% to 21% of the drug pipeline. For some pharmaceutical companies, like AstraZeneca 3 , 30% of their early pipeline consists of new drug modalities.

Development 52

Development In-Vivo Drugs In-Vitro 52

The Pharma Data

APRIL 30, 2021

Under the multi-year agreement, AbbVie will utilize Caribou’s next-generation Cas12a CRISPR hybrid RNA-DNA genome editing and cell therapy technologies to research and develop two new CAR-T cell therapies directed to targets specified by AbbVie. AbbVie and Caribou Biosciences, Inc., Full-Year 2021 Outlook.

Botox 40

Botox Production Development Cosmetics 40

Drug Discovery World

OCTOBER 20, 2022

CAFs are critical regulators of desmoplasia characteristic of this cancer, yet they are poorly characterised. used conventional flow cytometry analysis and FACS (fluorescence-activated cell sorting) to validate a pan-CAF marker along with CAF subpopulation-specific markers identified using single-cell RNA sequencing 3. Elyada et al.

Antibody 52

Antibody In-Vivo Life Science Development 52

The Pharma Data

JANUARY 4, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Israel’s Ministry of Health (MOH) has given authorization to import the COVID-19 Vaccine Moderna in Israel. Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients.

Vaccination 52

Vaccination Vaccine Medicine Containment 52