XTalks

APRIL 18, 2024

Roche has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Elecsys pTau217 early Alzheimer’s blood test. The Elecsys pTau217 assay is designed to detect amyloid pathology, a hallmark of Alzheimer’s disease, by measuring phosphorylated tau protein in human plasma.

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Drug Discovery World

OCTOBER 4, 2022

DDW Editor Reece Armstrong explores some of the trends that will be featured in sessions throughout ELRIG Drug Discovery 2022 and the news behind them. Indeed, the first two quarters have shown strong performance compared to 2021, with the number of ATMP trials in Phase I increasing 4%. . billion, compared to $19.9

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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. These tumor-derived entities are used to derive genomic and proteomic data. Concentration of CTCs in Cancer Patients.

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Drug Discovery World

DECEMBER 13, 2022

The genetic anomaly blocks the chemical glycosylation of a biologically important protein. Using an experimental technique called exon skipping by antisense oligonucleotides, the team corrected a mistake in the FKTN gene that blocks the chemical glycosylation of a biologically important protein. . Modifying RNA function.

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The Pharma Data

DECEMBER 14, 2020

”) platform to transform drug discovery and development, and identify patients who will benefit from its portfolio of targeted oncology therapeutics, announced today new scientific data that substantiates blood brain barrier permeability (BBB) for its drug candidate LP-184. . DALLAS , Dec. Lantern’s A.I.

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Drug Discovery World

OCTOBER 27, 2023

Organ-chips combine cell culture with microfluidics to emulate the biological forces of different organ tissues and/or disease states, allowing pharmaceutical researchers to determine a drug candidates’ efficacy and toxicity ahead of clinical trials. Could organ-chips replace other research methods? Not yet, according to Ewart.

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The Pharma Data

MAY 31, 2022

Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include babies under two months old with spinal muscular atrophy (SMA). Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Evrysdi is now approved in the US to treat SMA in children and adults of all ages.

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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.

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XTalks

MARCH 6, 2024

Brain Awareness Week 2024 , taking place March 11 to 17 this year, is a global campaign that aims to demystify the complexities of the human brain and promote the significance of neuroscientific research. This relates to neurological conditions like dementia and Alzheimer’s disease, which account for up to 70 percent of dementia cases.

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pharmaphorum

NOVEMBER 9, 2022

for the purpose of advancing disease-modifying oral medicines for debilitating chronic neurodegenerative disorders, by enabling investigational new drugs (IND) studies. In ALS , the protein TDP-43 triggers neuroinflammation via activation of the innate immune sensor STING. It has been supporting NRG’s work since 2019.

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XTalks

APRIL 6, 2022

Register for this webinar to get an overview of the role of long non-protein coding RNAs (lncRNAs) in gene regulations. Therefore, these patients could have a clinical benefit from further treatment or participation in a clinical trial. Photo source: Inivata. Around 85 percent of cases are non-small cell lung cancer (NSCLC).

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Pfizer

AUGUST 15, 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 AUTHORIZED USE.

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The Pharma Data

DECEMBER 20, 2020

Food and Drug Administration (FDA) is plenty busy with COVID-19 vaccine Emergency Use Authorizations (EUAs) this month, but they’re also wrapping up the year with a few PDUFA dates for other therapies. The drug is a once-daily, beta-3 adrenergic agonist. The submission included data from two positive pivotal Phase III trials.

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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. Thus, the drug appears to be a promising therapeutic agent in treating different forms of cancer in combination with other drugs.

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The Pharma Data

SEPTEMBER 17, 2020

The test targets antibodies against the spike protein. Food and Drug Administration (FDA). 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.

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Drug Discovery World

DECEMBER 29, 2023

Dr Sofia Ferreira, Director of Applications at Refeyn, discusses how various technologies can address the main challenges in membrane protein characterization, describing how novel technologies, such as mass photometry, can streamline and support analytical processes. Scientists use a multitude of membrane mimetics to overcome this issue.

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XTalks

APRIL 22, 2022

Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. All drug development processes evaluate a drug’s pharmacokinetics (PK) to gather data about its absorption, distribution, metabolism, and excretion in the body.

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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.

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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.

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The Pharma Data

SEPTEMBER 1, 2020

Food and Drug Administration (FDA). 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.

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The Pharma Data

MAY 27, 2022

Food and Drug Administration (FDA), are planned this year. 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.

Antibody 52

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Drug Discovery World

FEBRUARY 22, 2024

This article is sponsored by Collaborative Drug Discovery. Since its inception, Libra has used CDD Vault as its primary repository for all compound structural data and screening assay results, along with physicochemical and other in vitro biology data and associated metadata generated by its CRO partners.

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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] ).

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The Pharma Data

JULY 23, 2021

In addition to the REGN-COV 2067 trial in non-hospitalised patients, Ronapreve is currently being assessed in a phase II/III clinical trial for the treatment of COVID-19 in hospitalised patients (REGN-COV 2066). Roche’s Chief Medical Officer and Head of Global Product Development.

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Pfizer

DECEMBER 20, 2022

FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets).

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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). Characteristics of Biologic Products.

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The Pharma Data

MAY 18, 2021

Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. This Phase III trial is the designated PMR for the first-line mUC indication and met its co-primary endpoint of progression-free survival.

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The Pharma Data

SEPTEMBER 16, 2020

Blueprint Medicines will present new data from the registrational phase I/II ARROW trial, investigating Gavreto TM (pralsetinib) for the treatment of people with RET-mutant medullary thyroid cancer. New and updated data from across our broad cancer portfolio including phase III results in breast, lung and prostate cancers.

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Drug Discovery World

AUGUST 2, 2023

Genoscience Pharma’s Philippe Halfon and Eric Raymond share their expertise on targeting the recycling of unsustainable production of palmitoylated cancer-associated proteins. Palmitoyl transferases are a zinc finger Asp-His-His-Cystype (ZDHHC) family containing 23 distinct mammalian genes (excluding ZDHHC10) that catalyse this reaction 1.

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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,

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Drug Discovery World

JULY 22, 2022

Humanised immune system (HIS) mouse models that express human cytokines and support a broad range of human immune cell types have become integral tools to investigate and advance oncology drug discovery focused on cell-based therapies, which make up a growing proportion of cancer treatments. Jespersen et al.

In-Vivo 52

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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.

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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.

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The Pharma Data

APRIL 27, 2021

Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. The FDA has not announced when it will make its final decision for Tecentriq in this indication.

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Pfizer

JANUARY 27, 2023

Working with collaborators, we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern. and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., It is important to note that these studies are required by U.S.

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Pfizer

DECEMBER 13, 2022

In June of 2022, Pfizer submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of PAXLOVID for patients who are at high risk of progression to severe disease from COVID-19. The target Prescription Drug User Fee Act (PDUFA) action date for a decision by the FDA is in February 2023.

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The Pharma Data

JANUARY 27, 2021

FDA Investigational New Drug (“IND”)-enabling pharmacology studies. We look forward to working with Eurofins Discovery to bring this treatment to patients as quickly as possible as we prepare for our IND and trials,” said BetterLife’s Chief Executive Officer, Dr. Ahmad Doroudian.

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