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. About the Phase 1/2 clinical trial. About previously-published preclinical results.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

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. If approved, it could become a $500 million-a-year product, according to the company.

Gene Silencing 52

Gene Silencing RNA Protein Gene 52

pharmaphorum

DECEMBER 7, 2020

China’s Sinovac has raised $515 million to increase its distribution and production capacity as clinical development of its potential coronavirus vaccine nears conclusion. Sinovac has a coronavirus vaccine in late-stage development, which is undergoing large-scale trials in Brazil, Pakistan, Indonesia and Chile.

Vaccination 59

Vaccination Vaccine Production Clinical Development 59

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.

Vaccination 77

Vaccination Vaccine RNA Clinical Trials 77

pharmaphorum

OCTOBER 6, 2020

In the case of a rolling review, the EMA evaluates trial data as they become available before a complete filing is submitted. The vaccine is based on different technology from AZ’s rival: while AZ’s uses a weakened and genetically modified cold virus to prime the immune system, BNT162b2 is based on a string of RNA.

Vaccination 59

Vaccination Vaccine RNA Immune Response 59

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

Vaccination 80

Vaccination Vaccine Manufacturing RNA 80

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. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

pharmaphorum

NOVEMBER 9, 2020

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. 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.

Vaccination 98

Vaccination Vaccine Clinical Trials Clinical Trials 98

pharmaphorum

NOVEMBER 23, 2021

GlaxoSmithKline has joined the ranks of drugmakers trying to develop new drugs for non-alcoholic steatohepatitis (NASH) – a condition with no approved therapies and a lengthy list of failed drug candidates – via a deal with Arrowhead Pharmaceuticals.

Sales 52

Sales Drugs Trials RNA 52

The Pharma Data

DECEMBER 8, 2020

Silverback’s lead candidate is currently in a Phase I trial in adults with HER2-expressing solid tumors. Now poised to advance a robust therapeutics pipeline to clinical development, Nuance will use the funds for ongoing R&D of existing products and business development of potential new assets. Nuance Pharma .

RNA 52

RNA Antibody Life Science Protein 52

The Pharma Data

OCTOBER 25, 2020

We are advancing the clinical development of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Development 52

The Pharma Data

OCTOBER 19, 2020

With over 300 active clinical trials, Winship researchers are dedicated to taking new cancer treatments from bench to bedside. cancer centers selected as a Lead Academic Participating Site for the NCI’s National Clinical Trials Network (NCTN). Winship is one of 32 U.S.

Life Science 52

Life Science Clinical Trials Clinical Trials RNA 52

Drug Discovery World

MARCH 7, 2023

Powers taught for more than six years at the National Institutes of Health, on medical product development and commercialisation, and at Georgetown Law School as an adjunct professor. She founded Neuroute in 2019, with the aim of empowering patients from diverse backgrounds to participate in drug trials.

Life Science 98

Life Science DNA Clinical Development Development 98

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., 29, 2020 06:00 UTC. CAMBRIDGE, Mass.–(

Vaccination 40

Vaccination Vaccine Manufacturing Clinical Trials 40

The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. Pending discussions with the FDA, the oral vaccine will enter Phase I trials as a prime and boost, and will be explored to provide a boost to subcutaneous vaccinations.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

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. .

Gene Therapy 52

Gene Therapy Drugs Gene Manufacturing 52

Drug Discovery World

OCTOBER 16, 2023

A company within this ecosystem is STORM Therapeutics, a clinical stage biotechnology company creating novel small molecule therapies that inhibit RNA modifying enzymes (RME) for use in oncology and other diseases. CellProthera also appointed the Newcastle Centre for Life’s GMP cell therapy centre to produce the ATMP.”

Drugs 75

Drugs Life Science Gene Therapy Genome 75

The Pharma Data

JULY 18, 2021

Randomized controlled trials assessing the clinical efficacy of VAXNEUVANCE compared to PCV13 have not been conducted. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F individually conjugated to CRM 197 carrier protein. pneumoniae serotypes contained in the vaccine.

Immune Response 52

Immune Response Vaccination Vaccine FDA Approval 52

Drug Discovery World

DECEMBER 26, 2023

Scientists from the Chemistry and Biochemistry Departments at the University of Liverpool and Nanjing Medical School in China discovered a possible way to block proteins that cause metastasis. The open-label, single patient cohort ascending dose trial followed promising preclinical data for LEU011 in a spectrum of solid tumour models.

Development 64

Development Clinical Trials Clinical Trials Drugs 64

The Pharma Data

JUNE 25, 2021

To identify strains causing COVID-19 infections within the trial, sequencing of virus variants has so far been performed on 474 COVID-19 cases, of which 124 fulfilled adjudication criteria and were included in the present efficacy analysis. CureVac began development of mRNA-based COVID-19 vaccine candidates in January 2020.

Vaccination 52

Vaccination Vaccine Trials Immune Response 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

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. About AstraZeneca. AstraZeneca.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

Drug Discovery World

JANUARY 17, 2024

Brett Swansiger, Chief Commercial Officer at ANGLE discusses the importance of liquid biopsies in precision medicine trials for cancer. Furthermore, oncology clinical trials are frequently challenged by low enrolment rates, failure to achieve primary endpoints, study design complexity and limited funding 5.

Medicine 59

Medicine DNA Genome Genomics 59

XTalks

OCTOBER 26, 2023

She has 23 years of experience working with clients to move vaccine candidates through the clinical development pipeline, including regulatory submission. 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.

Vaccination 105

Vaccination Vaccine RNA Manufacturing 105

Drug Discovery World

NOVEMBER 30, 2023

This presentation covered three primary drivers for a protein expression model: speed, cost and sustainability. “It The next presentation attended in this track was the keynote presentation, which was given by Kate Smith, PhD, Head of UK Protein & Cell Sciences at GSK. GSK has developed high-throughput mammalian and E.

Antibody 59

Antibody Protein Engineer In-Vivo 59

The Pharma Data

OCTOBER 14, 2020

is a clinical-stage biopharmaceutical company developing novel RNA-modulating drug candidates (designed to be eukaryotic ribosomal selective glycosides) that are formulated to treat rare and ultra-rare premature stop codon diseases. Premature stop codons are point mutations that disrupt protein synthesis from messenger RNA.

Protein 52

Protein RNA Production Genetics 52

pharmaphorum

NOVEMBER 4, 2022

Pfizer’s gIRV encodes the haemagglutinin – the surface protein of the influenza virus that plays a role in the initiation of infection – of four different influenza strains and is recommended for the Northern Hemisphere 2022/23 by the World Health Organization.

Vaccination 52

Vaccination Vaccine Immune Response RNA 52

Drug Discovery World

OCTOBER 17, 2023

Today, spatial omics technologies enable imaging-based identification of cells in their native tissue context while simultaneously detecting hundreds of RNAs or tens of protein markers in the same cells. There is a lack of data and case studies beyond pilot projects related to patient recruitment and clinical trials.

Gene Expression 52

Gene Expression Drugs Protein Gene 52

The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. Late Breaking Oral Presentation OALC01LB03. Abstract 2361. Hillier et al.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Development 52

The Pharma Data

OCTOBER 27, 2020

Molecular Partners, a global leader in the development of DARPin® therapeutics, will be responsible for the conduct of phase 1 & 2 trials that may lead to emergency use approval; Novartis will be responsible for further development, manufacturing, distribution and commercialization.

Development 52

Development Protein Manufacturing Medicine 52

The Pharma Data

NOVEMBER 24, 2020

Professor and Chief, Pediatric Nephrology and Hypertension, Jack and Lucy Clark Department of Pediatrics, Mount Sinai Kravis Children’s Hospital, New York City and Investigator on the ILLUMINATE-A trial. Saland, M.D., HAO1 encodes glycolate oxidase (GO), an enzyme upstream of the disease-causing defect in PH1.

FDA Approval 52

FDA Approval Production RNA Medicine 52

Drug Discovery World

MAY 28, 2023

1 Clinical trials Until recently, medicines and vaccines were mainly tested on men. But our world is incredibly diverse, incredibly heterogenous, there is such a broad spectrum, so clinical trials need to represent that.” These findings demonstrate regeneration and functional restoration of the urinary sphincter.

Drugs 52

Drugs Vaccination Vaccine Research 52

XTalks

AUGUST 2, 2023

Stelara’s patents are expiring in September 2023, while a handful of biosimilar drugs are in late-stage development or seeking FDA approval. 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.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

NOVEMBER 30, 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 that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis. “I

Vaccination 52

Vaccination Vaccine Medicine Clinical Trials 52

The Pharma Data

SEPTEMBER 22, 2020

Trial design and other details are being evaluated and a comprehensive update on the overall Novartis SMA clinical development program will be provided at a future time following further discussions with health authorities. This guidance provides clarity on the path to registration for AVXS-101 IT.

Clinical Development 52

Clinical Development Gene Therapy Development Gene 52

Pfizer

NOVEMBER 2, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the advancement of an mRNA-based combination vaccine candidate for influenza and COVID-19 to a Phase 1 trial with the aim to address two severe respiratory diseases with one vaccine. 5) vaccine, each of which is based on BioNTech’s proprietary mRNA platform technology. . INDICATION.

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

XTalks

DECEMBER 24, 2020

SARS-CoV-2 is characterized by an outer surface speckled with spike proteins, giving it a crown-like appearance, hence the name “corona,” which is the Latin word for crown. The spike protein is critical for binding to ACE2 receptors on host cells — this interaction mediates the entry of the virus into cells.

Life Science 111

Life Science Vaccination Vaccine Gene 111