XTalks

JANUARY 27, 2021

The company used in vitro neutralization antibody studies to evaluate the activity of Moderna’s vaccine-generated antibodies in human sera against several variants of the novel coronavirus, including the B.1.1.7 The in vitro study evaluated the ability of mRNA-1273-generated antibodies to neutralize the new SARS-CoV-2 variants.

Vaccination 52

Vaccination Vaccine In-Vitro Protein 52

The Pharma Data

JANUARY 12, 2021

INCHEON, South Korea–( BUSINESS WIRE )– Celltrion Group today announced top-line results from its randomised, double-blind, and placebo controlled global Phase II/III clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. days quicker compared to placebo. days; 95% C.I, days; 95% C.I,

Clinical Trials 40

Clinical Trials Clinical Trials Trials In-Vivo 40

XTalks

AUGUST 8, 2024

Tecelra works by using the patient’s own immune system to target tumors expressing the melanoma-associated antigen A4 (MAGE-A4) protein on cancer cells. Clinical trial results for the therapy are expected to be shared in late 2024. The trial showed a 43 percent response rate with 4.5 percent achieving complete remission.

Engineer 52

Engineer Clinical Trials Clinical Trials FDA Approval 52

XTalks

APRIL 18, 2024

The Elecsys pTau217 assay is designed to detect amyloid pathology, a hallmark of Alzheimer’s disease, by measuring phosphorylated tau protein in human plasma. The Elecsys pTau217 assay is being developed for various use case scenarios, including clinical trials or determining eligibility for approved disease-modifying therapies.

Clinical Trials 52

Clinical Trials Clinical Trials In-Vitro Protein 52

The Pharma Data

DECEMBER 14, 2020

AbbVie has initiated a Phase I clinical trial of the antibody, and it will conduct the initial clinical program in the U.S. The antibody targets a specific conserved region of the SARS-CoV-2 spike protein. The fully human, non-blocking antibody, 49F1, targets a specific region of the SARS-CoV-2 spike protein.

Antibody 52

Antibody Licensing Licensing In-Vitro 52

The Pharma Data

APRIL 29, 2022

About Evrysdi® (risdiplam) Evrysdi is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to SMN protein deficiency. Evrysdi is designed to treat SMA by increasing and sustaining the production of the SMN protein in the central nervous system (CNS) and peripheral tissues.

Protein 52

Protein In-Vitro Medicine Development 52

The Pharma Data

MAY 31, 2022

More than 5,000 patients have now been treated worldwide with Evrysdi in clinical trials, compassionate use or real-world settings. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. Jude Children’s Research Hospital.

FDA Approval 52

FDA Approval Protein In-Vitro Medicine 52

pharmaphorum

NOVEMBER 9, 2022

A pre-clinical pipeline of potential first-in-class brain-penetrant small molecule inhibitors of the mitochondrial permeability pore (mPTP) are to be developed. Inhibition of the mPTP has been shown, however, to protect neurons, reduce neuroinflammation, and extend survival in pre-clinical disease models.

In-Vitro 52

In-Vitro Bioavailability Medicine 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

JANUARY 6, 2021

A Novel Ebola Virus VP40 Matrix Protein-Based Screening for Identification of Novel Candidate Medical Countermeasures.’ In vitro studies showed that when OYA1 is dosed with remdesivir both compounds are markedly more effective inhibiting Ebola virus replication and do so at much lower doses than is needed with either compound alone.

Clinical Trials 40

Clinical Trials Clinical Trials Drugs In-Vitro 40

The Pharma Data

AUGUST 18, 2020

REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S. Schleifer, M.D.,

Antibody 52

Antibody Clinical Trials Clinical Trials Manufacturing 52

The Pharma Data

DECEMBER 14, 2020

Many drugs fail in clinical trials because of their low blood brain barrier permeability. The effectiveness of standard therapy with TMZ is limited because the response of GBM to TMZ is dependent upon the expression of the DNA repair enzymatic protein, O 6 -alkylguanine DNA alkyltransferase (MGMT). Lantern’s A.I.

Drugs 52

Drugs Genome Genomics DNA 52

The Pharma Data

SEPTEMBER 1, 2020

Antigen test reliably and quickly triages people suspected of SARS-CoV-2, with results ready in 15 minutes, allowing informed treatment decisions. Antigen test accurately screens individuals with known exposure to infected SARS-CoV-2 patients, providing fast answers regarding their infection status. Food and Drug Administration (FDA).

In-Vitro 52

In-Vitro Antibody Medicine Clinical Trials 52

pharmaphorum

NOVEMBER 2, 2021

In 2019, there were 57 bsAb candidates in clinical trials, against both haematological and solid tumours. They eliminate the need to extract T cells for manipulation, expanding the accessibility of immuno-oncology to patients and clinical areas currently unmet by cell-based therapies, such as CAR T-cell treatments.

Antibody 52

Antibody Immune Response Production Engineer 52

XTalks

JUNE 12, 2023

Medtronic’s proactive stance towards R&D is evident from the over 230 clinical trials it conducted and the more than 200 regulatory approvals it received in the US, Europe, Japan and China in the 2022 fiscal year. Note: When it comes to companies that report in foreign currencies, the conversion to U.S.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

The Pharma Data

MAY 27, 2022

Glofitamab is being investigated in several clinical trials and explored in earlier lines of lymphoma treatment. This dual targeting activates and redirects a patient’s existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. After a median follow-up of 12.6 months, 39.4%

Antibody 52

Antibody In-Vitro Medicine Engineer 52

The Pharma Data

SEPTEMBER 2, 2020

Initiation of Phase IIIb OCREVUS higher dose clinical trial programme and Phase IV study evaluating OCREVUS in minority populations. New data further reinforce OCREVUS (ocrelizumab) as a highly effective treatment option offering a favourable and consistent benefit:risk profile, with high treatment persistence and adherence.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Medicine 52

The Pharma Data

SEPTEMBER 10, 2020

OCREVUS is the first and only treatment approved for both relapsing MS (RMS) and primary progressive MS (PPMS) and now more than 170,000 people have been treated with OCREVUS globally in clinical trial and real-world settings; favourable benefit-risk profile remains consistent over 7 years. Separate data from a U.S.

In-Vitro 52

In-Vitro Medicine FDA Approval Clinical Trials 52

The Pharma Data

MAY 17, 2023

Additionally, pre-clinical data have shown fenebrutinib to be potent and highly selective, and it is the only reversible inhibitor currently in Phase III trials for MS. “I I am encouraged by this clinical data for fenebrutinib, which is important news for people living with MS,” said Levi Garraway, M.D.,

In-Vitro 40

In-Vitro FDA Approval Trials Clinical Trials 40

The Pharma Data

DECEMBER 13, 2020

The STAMP-NAFLD trial was a 12-week, randomized, parallel group study in 120 presumed NASH patients with or without type 2 diabetes (T2DM). The Company additionally announced new preclinical results and plans for a Phase 2b trial focused on patients with noncirrhotic biopsy-proven NASH and coexisting prediabetes or T2DM.

Trials 40

Trials In-Vitro Insulin Protein 40

XTalks

NOVEMBER 7, 2022

Liquid biopsies have demonstrated promising activity in multiple clinical settings, but the great enthusiasm and expectations around them can be harmful if not adequately managed,” said Dr. El Mustapha Bahassi, PhD, Director, Clinical Laboratory Sciences, at the global clinical research organization (CRO) Medpace.

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. Recombinant therapeutic proteins. Fusion proteins. Gene and cellular therapies. Growth factors. Interferons. Monoclonal antibodies (mAbs).

Development 180

Development Protein Production Hormones 180

XTalks

FEBRUARY 1, 2023

The researchers found that factors in the blood can potentially predict the risk of developing the disease years before a clinical diagnosis is made. Among individuals diagnosed with MCI, ten to 15 percent of them progress to Alzheimer’s disease as observed in clinical studies and five to ten percent in population studies.

Research 98

Research In-Vitro Protein Development 98

The Pharma Data

SEPTEMBER 17, 2020

The test targets antibodies against the spike protein. 1 Specifically, the test targets antibodies which are directed against the particular region of the viral spike protein responsible for binding to the host cell receptor, which is required for the virus to enter the host cell. said Thomas Schinecker, CEO Roche Diagnostics.

Antibody 52

Antibody Vaccination Vaccine In-Vitro 52

XTalks

MAY 12, 2022

Clinical immunosuppression drugs such as ciclosporin, tacrolimus, sirolimus, prednisone and everolimus are administered to the recovering recipients to prevent transplant rejection. This diagnostic assay works on the principle of in vitro nucleic acid amplification using real-time transcription-mediated amplification (TMA) technology.

In-Vitro 52

In-Vitro DNA Development Genomics 52

The Pharma Data

AUGUST 3, 2021

Bristol Myers Squibb conducted a subsequent confirmatory Phase 3 study evaluating romidepsin plus CHOP (Ro-CHOP) versus CHOP in first-line PTCL patients, but the trial did not meet the primary efficacy endpoint of progression free survival. senior vice president, Hematology Development, Bristol Myers Squibb.

In-Vitro 52

In-Vitro Nurses Gene Expression Medicine 52

The Pharma Data

JANUARY 11, 2021

Using its novel yeast display system and large diverse human antibody libraries, AvantGen has identified a panel of high affinity human monoclonal antibody clones that bind to two distinct epitopes on the receptor binding domain of the SARS-CoV-2 spike protein. These findings have been published in Frontiers in Immunology ( [link] ).

Antibody 52

Antibody Licensing Licensing Development 52

The Pharma Data

APRIL 23, 2021

Roche announces positive CHMP opinion for Venclyxto-based combinations in certain patients with acute myeloid leukaemia. Venclyxto combinations significantly improved complete response rates in people with newly diagnosed acute myeloid leukaemia in two key studies (VIALE-A and M14-358). The median OS was 14.7 months (95% CI: 11.9, months (95% CI: 7.4,

Medicine 40

Medicine In-Vitro Antibody Development 40

The Pharma Data

MARCH 17, 2021

This analysis revealed the addition of Verzenio to ET did not result in a clinically meaningful difference in patients reporting being bothered by treatment side effects. The detailed data were presented at the virtual 17th St. Gallen International Breast Cancer Conference. Overall, patient compliance for PROs was greater than 90 percent.

HR 52

HR Trials In-Vitro Manufacturing 52

The Pharma Data

JANUARY 17, 2021

The year is starting to pick up in terms of clinical trial announcements. NeuroRx , Relief Therapeutics and Quantum Leap Healthcare Collaborative (QLHC) announced that NeuroRx and QLHC have signed a Clinical Trial Participation Agreement for the inclusion of Zyesami (RLF-100 aviptadil) in the I-SPY COVID-19 trial.

Immune Response 52

Immune Response Antibody Trials Clinical Trials 52

Pharmaceutical Technology

NOVEMBER 22, 2022

Messenger RNA vaccines contain nucleic acids that code for a specific protein, or target antigen, related to a virus or disease. When an mRNA vaccine is administered, a patient’s body produces that protein to prompt a desired immune response. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed.

Manufacturing 130

Manufacturing Vaccination Vaccine RNA 130

Pfizer

JANUARY 27, 2023

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. The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision.

Marketing 75

Marketing Production Drugs Licensing 75

pharmaphorum

NOVEMBER 4, 2020

It may not be appropriate to use the word ‘failure’ when summarising the utility of clinical trials in the search for a curative or preventative treatment for disease. Most of the trials are underpowered to demonstrate efficacy on mortality and long-term consequences of the disease.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Vaccination 105

XTalks

MARCH 2, 2021

The 66 percent efficacy determined for the J&J vaccine is for the prevention of mild to moderate disease, an average derived from the companies’ global Phase III trials. The knee-jerk reaction among some has been to deem the vaccine inferior to other authorized counterparts that have higher efficacies.

Vaccination 97

Vaccination Vaccine Trials Clinical Trials 97

Delveinsight

JANUARY 12, 2021

Birinapant is a clinical-stage SMAC mimetic that degrades Inhibitors of Apoptosis Proteins (IAPs) by binding to them, ultimately leading to cell death in tumor cells. million after Birinapant successfully becomes a part of the Phase I trials. The duo will jointly develop the therapy, conducting clinical trials globally.

Licensing 52

Licensing Licensing Antibody Gene Therapy 52

Pfizer

DECEMBER 20, 2022

Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. 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. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. In the U.S.,

Drugs 69

Drugs Licensing Licensing Containment 69

Pfizer

DECEMBER 13, 2022

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. Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, The additional 3.7

Drugs 110

Drugs Licensing Licensing Production 110