pharmaphorum

MAY 11, 2021

The vaccine could play an important role in the next stage of the pandemic as phase 3 trials have shown encouraging safety and efficacy data. Importantly the vaccine can be stored in a fridge, unlike the rivals from Pfizer/BioNTech and Moderna, which require storage at ultra-cool temperatures to maintain their delicate RNA structure.

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Vaccination Vaccine RNA Regulation 62

pharmaphorum

DECEMBER 1, 2020

Pfizer and BioNTech have filed their COVID-19 vaccine with the European medicines regulator, paving the way for a potential approval before the end of the year. The companies initially filed the nonclinical data and other technical data, followed by emerging clinical trial results.

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Vaccination Vaccine RNA Clinical Trials 86

pharmaphorum

MARCH 9, 2022

The XTEND-1 trial also showed that BIVV001 was better at reducing the annualised rate of bleeding episodes than patients’ previous therapies, according to Sanofi and Sobi, which said they will now talk to regulators to chart a path forward to approval. The half life of the new drug – one of the main draws for Sanofi’s $11.6

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Protein Sales Gene Therapy Regulation 98

pharmaphorum

NOVEMBER 18, 2021

The two companies have been working together since 2019 to develop multiple RNA interference (RNAi) candidates for disorders such as non-alcoholic steatohepatitis (NASH), type 2 diabetes, obesity and rare diseases. billion in cash. The transaction is expected to close in the fourth quarter of this year.

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pharmaphorum

NOVEMBER 17, 2020

The vaccine developed in partnership with Germany’s BioNTech has been shown to be 90% effective in clinical trials. The company has picked four US states – Rhode Island, Texas, New Mexico and Tennessee, to trial a delivery programme that aims to overcome this challenge. Pfizer and BioNTech have a $1.95

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Vaccination Vaccine RNA Clinical Trials 75

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. In the case of a rolling review, the EMA evaluates trial data as they become available before a complete filing is submitted.

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Vaccination Vaccine RNA Immune Response 57

Drug Discovery World

JANUARY 23, 2023

Additionally, the clinical trial period will be considerably shorter than that required for new drug development. As an FDA-approved oral drug, the side-effects of cladribine are quite manageable and it has been well evaluated for pharmacokinetics.

FDA Approval 52

FDA Approval Drugs In-Vivo In-Vitro 52

Drug Discovery World

APRIL 11, 2023

The molecule, known as lissodendoric acid A, appears to counteract other molecules that can damage DNA, RNA and proteins and even destroy whole cells. USP30 is a (de)ubiquitylation (DUB) implicated in neurodegenerative diseases that regulates the clearance of damaged mitochondria in a process called mitophagy.

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Research Drugs Life Science RNA 52

pharmaphorum

DECEMBER 16, 2020

Moderna looks odds on to claim emergency use authorisation from the FDA for its COVID-19 vaccine this week, after the regulator published a report endorsing its safety and rating its efficacy at 94.5%. The overall 94.5% Very encouraging! pic.twitter.com/6IVSj8E3F0. — Eric Topol (@EricTopol) December 15, 2020.

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pharmaphorum

FEBRUARY 19, 2021

billion cumulative doses of its NVX-CoV2373 recombinant protein-based vaccine candidate, which is yet to be approved by regulators. NVX-CoV2373 is being studied in two ongoing pivotal phase 3 clinical trials: in the United States and Mexico, as well as in the UK for the prevention of COVID-19. The post Novavax provides 1.1

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pharmaphorum

DECEMBER 7, 2020

Sinovac has a coronavirus vaccine in late-stage development, which is undergoing large-scale trials in Brazil, Pakistan, Indonesia and Chile. This means they do not require the ultra-cool temperatures needed to store the RNA-based vaccines from Pfizer/BioNTech and Moderna. According to the state-run Indonesian news agency Antara, 1.2

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pharmaphorum

NOVEMBER 9, 2020

The companies said they will be ready to file the vaccine with the FDA in the third week of November once they have enough safety data to meet the regulator’s requirements. Top-line results come from a phase 3 trial of the candidate known as BNT162b2 and an evaluation of 94 cases from the trial of 43,538 patients.

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The Pharma Data

MARCH 3, 2022

In 2014, Shalev’s UAB research lab reported that verapamil completely reversed diabetes in animal models, and she announced plans to test the effects of the drug in a human clinical trial. Fifty-three proteins showed significantly altered relative abundance over time in response to verapamil.

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Insulin Gene Expression Gene Protein 52

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. Its job is to carry coding information that is essential to the translation and processing of functional proteins.

RNA 52

RNA Protein Vaccination Vaccine 52

XTalks

APRIL 6, 2022

XTALKS WEBINAR: Using CRISPR interference (CRISPRi) Viability Screens to Map Long Noncoding RNA Dependencies in Tumor Cells. Register for this webinar to get an overview of the role of long non-protein coding RNAs (lncRNAs) in gene regulations. Live and On-Demand: Thursday, April 21, 2022, at 11am EDT (4pm BST/UK).

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DNA In-Vitro Doctors Doctor 105

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.

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Vaccination Vaccine Doctors Doctor 109

Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug. For more information, please download our white paper.

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Bioequivalency Production Branding Contamination 130

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.

RNA 52

RNA Drugs Gene Silencing Vaccination 52

STAT News

MARCH 6, 2023

Cambridge-based Moderna recently reported encouraging results from a study of another type of personalized cancer vaccine it developed with the pharmaceutical giant Merck; it uses messenger RNA technology to target advanced melanoma. Neoantigen vaccines are designed to target certain proteins called neoantigens on tumor cells.

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The Pharma Data

AUGUST 30, 2021

Overall, Leqvio was well-tolerated, with a safety profile similar to placebo and consistent with the overall pooled population from the combined trials 1 – 3. As the first and only small interfering RNA to provide effective and sustained LDL-C reduction, Leqvio helps manage a critical cardiovascular risk factor for ASCVD.

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RNA Trials Production Containment 52

Roots Analysis

AUGUST 31, 2023

Further, the expression of any gene is dependent on the rate at which it is transcribed into mRNA and translated into proteins. There are various regulatory proteins or transcription factors that are responsible for affecting the transcription rate. When activator binds to the operon, it either speeds up or permits gene expression.

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Gene Gene Therapy Gene Expression Regulation 40

Drug Discovery World

SEPTEMBER 28, 2022

AI-based diagnostic software and clinical trials technology proved to be two of the most attractive health investments, alongside mental health and wellness and medical imaging companies. . According to Hampleton Patners’ latest Healthtech M&A market report2, digital health companies raised a total of $57.2

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Pharma Companies Drugs In-Vivo Genetics 52

XTalks

AUGUST 30, 2022

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Such therapies may involve small interfering RNA (siRNA) or oligonucleotides in viral transfection platforms, large molecules and antibodies.

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Pfizer

AUGUST 15, 2022

Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. HMG-CoA reductase inhibitors: lovastatin, simvastatin.

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The Pharma Data

DECEMBER 18, 2020

The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. Director of the FDA’s Center for Biologics Evaluation and Research.

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Vaccination Vaccine Production Manufacturing 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.

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Big Data Development Life Science Drugs 40

Pharmaceutical Technology

FEBRUARY 1, 2023

As an RNA virus, like SARS-CoV-2, RSV is highly prone to mutations. However, specific antibody-resistant mutations have already been documented within the RSV- F protein after prophylactic administration of nirsevimab. This is concerning as nirsevimab was very recently approved in only two regions.

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Vaccination Vaccine Antibody Protein 162

The Pharma Data

NOVEMBER 16, 2020

We are pleased to submit these extended stability conditions for mRNA-1273 to regulators for approval. mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID’s Vaccine Research Center. CAMBRIDGE, Mass.–(BUSINESS

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Vaccination Vaccine Containment Pharmacy 52

Pfizer

JANUARY 27, 2023

Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus.

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Marketing Production Drugs Licensing 75

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.

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Vaccination Vaccine Development Marketing 52

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.

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Vaccination Vaccine Containment Clinical Trials 52

Delveinsight

JANUARY 18, 2021

However, DelveInsight’s Angelman syndrome market analysis report estimates that several approaches focused primarily on the Gene Therapies, Topoisomerase Inhibitors, Cannabidiol, Protein Phosphatase 2A inhibitor, among others are under development to find a cure for the Angelman syndrome. GeneTx and Ultragenyx are co-developing the therapy.

Marketing 52

Marketing Gene Drugs Protein 52

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

Drug Discovery World

AUGUST 10, 2022

And now, with more than 600 CAR T trials recruiting or ongoing, these cells represent a majority of the cellular immunotherapies in development today. To overcome this evasion tactic, the CAR protein was developed to recognise other markers on cancer cells. Exactly three decades later, the first CAR T cell therapy hit the market.

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Manufacturing Gene Genome Genomics 98

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.

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DNA Genome Genomics RNA 98

pharmaphorum

APRIL 12, 2021

Updated trial data from Pfizer and BioNTech announced at the beginning of the month showed the shot is around 91% effective at preventing the disease. Even if the South African variant does break through the vaccine’s protection, it has not spread widely through the population,” he said.

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Vaccination Vaccine RNA Protein 83

Drug Discovery World

MAY 5, 2023

Since the genes are fused, the chimeric RNA transcripts encode different proteins, altering their function. The case for exploring proximity fusions in solid tumours Figure 2: Gene fusions result from rearrangements and generate chimeric RNA transcripts.

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Genome Genomics Gene Genetics 52