XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. Exosome-Based Liquid Biopsy in Oncology.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

Camargo

NOVEMBER 29, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. Essentially, a biologic is a product that is produced from living organisms or that contains components of living organisms. Recombinant therapeutic proteins. Allergenics.

Development 180

Development Protein Production Hormones 180

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccine Vaccination 76

Worldwide Clinical Trials

SEPTEMBER 29, 2022

For studies of humanized therapeutics (monoclonal antibodies [mAb], fusion protein, antibody-drug conjugates [ADC], bispecific antibodies, etc.), In contrast, clinical trials focus on both safety and efficacy — the relationship between drug concentrations and pharmacological effects. anti-human IgG).

Reagent 130

Reagent Clinical Trials Clinical Trials Antibody 130

Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef. Tue, 07/26/2022 - 17:41.

Vaccine 111

Vaccine Vaccination Protein Immune Response 111

Pharmaceutical Technology

JANUARY 24, 2023

Developed with the University of Edinburgh, the EXACT self-contained technology enables MeCP2 protein therapeutic levels while avoiding overexpression-related toxicities. Neurogene stated that the FDA IND clearance allows it to commence a Phase II/II trial of NGN-401 in female paediatric Rett syndrome patients.

Gene Therapy 208

Gene Therapy Gene Gene Expression Regulation 208

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.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccine Vaccination 52

pharmaphorum

OCTOBER 2, 2020

Confirming press reports, the EMA said that large scale clinical trials from the vaccine codenamed AZD1222 involving several thousands of people are ongoing and results will become available over “the coming weeks and months”. The post European regulators begin rolling review of AZ’s COVID-19 vaccine appeared first on.

Regulation 105

Regulation Vaccine Vaccination Protein 105

The Pharma Data

MARCH 23, 2022

Polymerase is a viral protein that directs how Ebola virus replicates its genome as it infects new hosts. The researchers discovered that Ebola virus polymerase hijacks a cellular protein called GSPT1. To treat Ebola virus infections, researchers are taking a close look at a key piece of the virus: polymerase.

Protein 52

Protein Genome Genomics Research 52

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration were based on mRNA, more conventional protein-based vaccines have also shown promise in clinical trials. Most train the immune system to recognize the RBD, a peptide that is the portion of the SARS-CoV-2 spike protein that binds to the ACE-2 receptor on host cell surfaces. bioRxiv [Preprint].

Protein 52

Protein Vaccine Vaccination Antibody 52

The Pharma Data

MARCH 30, 2021

Basel, March 30, 2021 — Novartis has obtained exclusive worldwide rights to develop and commercialize therapeutic applications for a library of Fibroblast Activation Protein (FAP) targeting agents including FAPI-46 and FAPI-74, through an assignment agreement with iTheranostics, Inc., an affiliate of SOFIE Biosciences, Inc. Disclaimer.

Protein 52

Protein Licensing Licensing Containment 52

Camargo

APRIL 28, 2021

The first tasks in striking this balance are dose selection and dosing interval determination, and this blog post offers an overview on how PK modeling and simulation can be applied to optimize the safety and efficacy of a product for pediatric populations in clinical trials. First Steps Toward Initiating Pediatric Clinical Studies.

Clinical Trials 130

Clinical Trials Clinical Trials In-Vivo Drugs 130

Pharmaceutical Technology

FEBRUARY 1, 2023

However, specific antibody-resistant mutations have already been documented within the RSV- F protein after prophylactic administration of nirsevimab. Once fully approved, it is expected to completely replace Synagis from the market, given its higher efficacy and single-dose administration.

Vaccine 162

Vaccine Vaccination Antibody Protein 162

The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Containment 52

pharmaphorum

JUNE 9, 2022

Moderna’s new version of its COVID-19 vaccine, which targets two virus variants including Omicron, has outperformed the company’s original Spikevax shot in a head-to-head clinical trial. It has predicted sales of COVID-19 vaccines will be around $21 billion this year.

Vaccine 105

Vaccine Vaccination Containment Clinical Trials 105

XTalks

JANUARY 3, 2024

In individuals affected by ATTR, which includes both hereditary and wild-type (non-hereditary) variants, the TTR protein forms fibrils that accumulate in various tissues. Safety and Efficacy of Wainua The FDA’s approval of Wainua is underpinned by compelling clinical data. This conjugation facilitates ASO delivery to hepatocytes.

FDA Approval 105

FDA Approval Protein RNA Clinical Trials 105

The Pharma Data

JANUARY 17, 2021

The treatment is based on the Grifols immunoglobulin Gamunex®-C, and contains anti-SARS-COV-2 polyclonal antibodies from plasma donors who have recovered from COVID-19. It could also help contain outbreaks in places where the vaccination hasn’t begun or is still underway. BARCELONA, Spain , Jan. and on the U.S.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

XTalks

MAY 24, 2022

The FDA has allowed clinical trials assessing the injectable lenacapavir, an investigational long-acting HIV-1 capsid inhibitor in development by Gilead Inc., Now, Gilead has replaced the material of the container vial with aluminosilicate glass, proving it to be a good material for storage and compatibility. “We to continue.

Drugs 98

Drugs Clinical Trials Clinical Trials Trials 98

Pharmaceutical Technology

NOVEMBER 22, 2022

According to CEPI: “Achieving the 100 Days Mission would give the world a fighting chance of containing a future outbreak before it spreads to become a global pandemic.”. Messenger RNA vaccines contain nucleic acids that code for a specific protein, or target antigen, related to a virus or disease.

Manufacturing 130

Manufacturing Vaccine Vaccination RNA 130

The Pharma Data

DECEMBER 16, 2020

Currently in Phase 3 clinical testing in the United Kingdom for the prevention of COVID-19, NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax’ proprietary Matrix-M to enhance the immune response. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

Protein 52

Protein Vaccine Vaccination Immune Response 52

XTalks

NOVEMBER 23, 2020

The global trials are assessing the safety and efficacy of the vaccine in individuals aged 18 years or over from diverse racial and geographic groups who are healthy or have stable underlying medical conditions. Oxford-AstraZeneca COVID-19 Vaccine Induces Immune Responses in Early Clinical Trials.

Vaccine 97

Vaccine Vaccination Clinical Trials Clinical Trials 97

pharmaphorum

SEPTEMBER 14, 2020

While there may be just under 20,000 confirmed protein coding genes, it turns out that much of the genome outside of these genes is also important in regulating how the genome is controlled. Genomics also means we will be able to stratify patients, based upon their genomic makeup, to make clinical trials much more efficient and targeted.

Genome 119

Genome Genomics Medicine Gene 119

pharmaphorum

FEBRUARY 24, 2022

Viral or bacterial infections, or airway irritants can damage lung cells, causing them to release damage associated molecular pattern (DAMP) molecules that attach to and activate the receptor for advanced glycation endproducts (RAGE) protein found on a cell’s membrane. said Cantex CEO Stephen Marcus.

Licensing 64

Licensing Licensing Development Drugs 64

pharmaphorum

DECEMBER 2, 2021

In September, it reported a fourth patient death in a clinical trial of its AT132 (resamirigene bilparvovec) gene therapy for the rare disease X-linked myotubular myopathy (XLMTM), possibly linked to liver side effects. Those safety issues have hit Astellas’ aspirations in gene therapy directly.

Gene Therapy 97

Gene Therapy Gene Manufacturing Clinical Trials 97

Advarra

MARCH 10, 2023

Red blood cells contain hemoglobin, a protein that carries oxygen. hindering progress on SCD – there is also a lack of clinical trials and research. Diversity in Clinical Trials and SCD As many clinical trials in the U.S.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Doctor 98

Pfizer

AUGUST 3, 2022

Based on these results, the Phase 3 trial and further development of PF-07265803 will be discontinued. mitogen activated protein kinase pathway, which demonstrated improvement in functional capacity (6-minute walk test; 6MWT) in a 48-week, open-label, Phase 2 study among patients with symptomatic LMNA-related DCM. Disclosure Notice.

Development 101

Development Vaccination Vaccine Production 101

XTalks

JUNE 28, 2023

DMD is caused by the absence of dystrophin, a protein that helps maintain the integrity of muscle cells. The therapy’s strong clinical safety data helped Sarepta secure the approval, as among 85 patients, only 13 serious side effects and no deaths or discontinuations due to adverse events were reported.

Gene Therapy 98

Gene Therapy Gene Protein FDA Approval 98

The Pharma Data

JANUARY 7, 2021

HER2/ neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. GP2 is a 9 amino acid transmembrane peptide of the HER2/ neu protein.

Containment 52

Containment Clinical Trials Clinical Trials Protein 52

XTalks

SEPTEMBER 8, 2020

AZD1222 is now in Phase III clinical trials which will enroll approximately 30,000 adult volunteers in 80 states in the US, to determine whether the vaccine can help prevent symptomatic coronavirus disease from spreading. The genetic material contains SARS-CoV-2 spike protein.

Manufacturing 83

Manufacturing Vaccine Vaccination Allergies 83

pharmaphorum

AUGUST 16, 2020

The order comes after the Commission put agreements in place for the supply of two other vaccines – from Johnson & Johnson and Sanofi/GlaxoSmithKline – that will be activated if the shots prove their worth in clinical trials. Those deals cover 200 million doses of J&J’s Ad26.COV2.S

Vaccine 111

Vaccine Vaccination Immune Response Trials 111

XTalks

AUGUST 17, 2020

Cue Biopharma is a Cambridge, Massachusetts-based clinical-stage biotechnology company that is focused on developing injectable immune biologics using its proprietary Immuno-STAT (Selective Targeting and Alteration of T cells) platform. protein-based biologics) and vaccine treatments. Cell-Based Immunotherapy vs. Immune Biologics.

Protein 98

Protein Engineer Immune Response In-Vivo 98

XTalks

JUNE 16, 2021

Novavax shared the latest data from its ongoing late-stage COVID-19 vaccine trial, which shows that its yet-to-be authorized shot provides 100 percent protection against moderate and severe disease and has an overall efficacy of 90.4 Related: Latest Data from Novavax COVID-19 Vaccine Trial Involving B.1.351

Vaccine 98

Vaccine Vaccination Protein Trials 98

The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) has determined that OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA) patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019. Novartis today announced that the U.S. SVP, Chief Medical Officer, Novartis Gene Therapies. “We

Clinical Trials 52

Clinical Trials Clinical Trials Gene Therapy Gene 52

The Pharma Data

JULY 8, 2021

Today, access to the world’s largest browsable resource linking rare protein-coding genetic variants to human health and disease was launched through a genetic exome sequence analysis collaboration between AbbVie (NYSE: ABBV), Biogen Inc. PFIZER DISCLOSURE NOTICE: The information contained in this release is as of July 8, 2021.

Genetics 52

Genetics Biobanking Protein Containment 52

XTalks

JANUARY 5, 2021

The pandemic itself will also continue to spur innovations and changes such as greater shifts towards decentralized clinical trials and patient-centric approaches. In addition to vaccines, there are handfuls of drugs currently being evaluated in clinical trials for the treatment of COVID-19.

Life Science 98

Life Science Clinical Trials Clinical Trials Trials 98

pharmaphorum

SEPTEMBER 1, 2020

AstraZeneca has expanded development of COVID-19 vaccine AZD1222 into the US, beginning a phase 3 clinical trial across all adult age groups. The UK pharma said that the trial will recruit up to 30,000 adults aged 18 years or over to assess the safety, efficacy and immune response.

Vaccine 69

Vaccine Vaccination Trials Immune Response 69

The Pharma Data

DECEMBER 21, 2020

Phase I safety, tolerability, and pharmacokinetic study in healthy volunteers expected to start in coming weeks following acceptance of a request for a Clinical Trial Authorization (CTA) granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA). ALLSCHWIL, Switzerland, Dec.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Bacteria 40