Bio Pharma Dive

MARCH 22, 2023

Though the drug, called tofersen, missed the main goal of a key clinical trial, it showed an effect on a protein tied to ALS. Experts see that as a good sign, but some worry Biogen has not yet gathered enough supportive evidence.

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Bio Pharma Dive

SEPTEMBER 9, 2021

The French drugmaker bought Principia Biopharma last year for two therapies that block a protein called BTK. The second targets a much bigger disorder, multiple sclerosis.

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Protein Trials Drugs 291

Roots Analysis

MARCH 2, 2022

Orally administrable protein / peptide-based therapeutics offer several advantages including, effective treatment of numerous clinical conditions and degenerative disorders. Over 40 oral drug delivery technologies have been designed so far. Pipeline Overview of Oral Peptide and Protein-based Therapeutics.

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BioPharma Reporter

NOVEMBER 9, 2023

The proof-of-concept trial, dubbed IRIS-RA, is the first to investigate a treatment for rheumatoid arthritis that blocks a protein called neonatal Fc receptor (FcRn).

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Antibody Drugs Protein Trials 105

XTalks

MAY 7, 2021

As Novavax awaits emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its protein-based COVID-19 vaccine NVX-CoV2373, the company shared new data this week on the vaccine’s efficacy against the South African B.1.351 These results came from data from Novavax’s Phase III UK trial where B.1.117

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Bio Pharma Dive

MARCH 30, 2022

A drug regimen including Roche's top prospect tiragolumab didn't outperform standard treatment in its first large trial, a setback for therapies aimed at a protein called TIGIT.

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Protein Trials Drugs 284

Drug Discovery World

FEBRUARY 27, 2024

Arvinas has commenced dosing in the Phase I clinical trial of ARV-102, its first oral PROTAC (PROteolysis-TArgeting Chimera) protein degrader in development to treat neurodegenerative diseases. The post First PROTAC degrader for neurodegenerative disease enters trials appeared first on Drug Discovery World (DDW).

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Drug Discovery World

DECEMBER 19, 2023

The first patient has been dosed with an engineered B cell investigational therapy in a Phase I trial in Mucopolysaccharidosis type I (MPS I). Developer Immusoft has received FDA Orphan Drug Designation and Rare Pediatric Disease Designation for the therapy, designated ISP-001, in this indication.

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Engineer Trials Genetic Disease Gene Therapy 113

pharmaphorum

MARCH 19, 2021

Gain Therapeutics has priced its initial public offering, raising more than $40 million for its computational drug discovery platform and pipeline of drugs for diseases associated with protein misfolding. . The post Protein misfolding specialist Gain nets $40m from IPO appeared first on.

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Pharmaceutical Technology

MAY 4, 2023

ARTHEx Biotech will use the funds to advance an antimiR oligonucleotide, ATX-01, to a Phase I/IIa clinical trial in the second half of 2023. It has a dual mechanism of action that targets toxic dystrophia myotonica protein kinase and MBNL protein.

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Clinical Trials Clinical Trials Trials Protein 130

Fierce Pharma

APRIL 15, 2024

A Novartis drug with "pipeline in a pill" potential, according to one analyst group, has delivered on that promise once again. | In a phase 3 trial, treatment with Fabhalta led to a statistically significant 38.3% reduction of proteinuria (protein in the urine) in patients with IgA nephropathy, Novartis said on Monday.

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Protein Trials Drugs 112

Bio Pharma Dive

DECEMBER 1, 2022

Detailed clinical trial data for Roche's gantenerumab showed treatment cleared far less toxic protein from patients' brains than expected, potentially explaining its divergent result from Eisai’s lecanemab.

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Clinical Trials Clinical Trials Protein Research 156

Pharmaceutical Technology

OCTOBER 20, 2022

PIC Therapeutics has raised $35m in a Series A funding round led by OrbiMed to develop therapies for drug-resistant breast cancer. The company will utilise the Series A funds to progress its small molecule drug presently in development into first-in-human clinical trials for advanced metastatic breast cancer.

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Drug Discovery World

MARCH 29, 2023

A Phase I clinical trial has begun evaluating Direct Biologics’ ExoFlo for the treatment of patients with medically refractory ulcerative colitis (UC). The primary objective of the trial is to evaluate the safety of intravenous ExoFlo.

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Drug Discovery World

MARCH 8, 2024

The top stories: Antibody therapy shows anti-tumour activity in advanced cancer In an early phase clinical trial, a combination of antibody-based medications targeting the immune system generated promising safety data and anti-tumour activity in individuals with advanced cancer.

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Antibody Drugs Clinical Trials Clinical Trials 52

pharmaphorum

SEPTEMBER 23, 2020

One of the less well-known symptoms of COVID-19 is inflammation and injury to blood vessels, and US biotech Aerpio Pharma thinks it has a drug that may help avert the life-threatening blood clots that can result. The drug may also reduce lung inflammation and exert an antiviral effect.”.

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Trials Drugs Protein Development 103

Drug Discovery World

FEBRUARY 28, 2024

The first 20 participants have been enrolled in a multicentre trial to test whether ImmunityBio’s Nant Cancer Vaccine (NCV) could potentially prevent colon and other cancers in individuals with Lynch syndrome. Each of the three vaccines in Tri-Ad5 targets different proteins associated with precancer and cancer cells.

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Vaccination Vaccine Trials Protein 52

XTalks

OCTOBER 20, 2023

Clinical-stage genome editing company Intellia Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to start a pivotal phase III trial of NTLA-2001 for the treatment of transthyretin (ATTR) amyloidosis with cardiomyopathy.

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STAT News

NOVEMBER 28, 2022

Eisai’s announcement that lecanemab, its antibody drug for Alzheimer’s disease that targets the buildup of amyloid protein in the brain, modestly slowed cognitive decline in a Phase 3 trial offers hope to people with Alzheimer’s disease. ” Read the rest…

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Drugs Protein Antibody Trials 126

Pharmaceutical Technology

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. The breakthrough drug is predicted to be a blockbuster, generating total forecast sales of $12.9bn between 2023 and 2028. Leqembi is currently pending approval in the EU and Japan.

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Sales Drugs Antibody FDA Approval 147

XTalks

JULY 19, 2022

The US Food and Drug Administration (FDA) has given emergency use authorization (EUA) to Novavax’s COVID-19 vaccine, making it the fourth authorized vaccine in the US against COVID-19. Safety data came from about 26,000 clinical trial participants who were administered the vaccine and 25,000 who received placebo. The vaccine was 78.6

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Vaccination Vaccine Protein Clinical Trials 94

XTalks

DECEMBER 12, 2023

The world of neuroscience trials is rapidly evolving, presenting new challenges and opportunities for researchers and clinicians. The worldwide market for neurology clinical trials stood at a valuation of $5.24 There is currently a heightened emphasis on imaging and liquid biomarkers in neuroscience clinical trials.

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Pharmaceutical Technology

DECEMBER 23, 2022

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Sunlenca (lenacapavir) plus other antiretroviral(s) (ARV) to treat human immunodeficiency virus type 1 (HIV-1) infection. Subcutaneous lenacapavir’s antiviral activity administered every six months was analysed in the trial.

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Drug Discovery World

AUGUST 23, 2022

A Phase I/II clinical trial targeting a treatment for Huntington’s Disease (HD) using a gene therapy has been given the clearance to go ahead in France. . In 2019, BV-101 was granted orphan drug designation in the European Union. . There are currently no approved disease modifying therapies for Huntington’s Disease.

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Gene Therapy Gene Trials Clinical Trials 98

Drug Discovery World

NOVEMBER 8, 2023

Deepika Khedekar , Associate Centralized Clinical Lead at IQVIA, explains how artificial intelligence could make clinical trials more accurate, accessible and standardised. Tapping into the capabilities of AI One reason AI may accelerate clinical trials is its ability to rapidly process and analyse vast amounts of data.

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Clinical Trials Clinical Trials Trials Drugs 72

pharmaphorum

FEBRUARY 10, 2022

The 3rd Protein Degradation and Targeting Undruggables Summit is North America’s only in-person, industry-led conference covering clinical progress and commercial scale development of first-in-class degrader technology platforms. The post The Protein Degradation & Targeting Undruggables Congress appeared first on.

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Protein Development Drugs Clinical Trials 52

Pharma Times

MARCH 19, 2021

EP0042 is a dual-inhibitor drug designed to block the activity of two cancer-driving proteins

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Drugs Protein Trials 104

Pharmaceutical Technology

NOVEMBER 11, 2022

The European Commission (EC) has granted approval for Sanofi and GSK ’s monovalent, recombinant-protein-based, adjuvanted Covid-19 vaccine, VidPrevtyn Beta, as a booster in adults aged 18 years and above. These trials comprised the Phase III VAT08 Stage 2 trial analysing initial efficacy and two other immunogenicity trials.

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Pharmaceutical Technology

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. The breakthrough drug is predicted to be a blockbuster, generating total forecast sales of $12.9bn between 2023 and 2028. Leqembi is currently pending approval in the EU and Japan.

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Sales Drugs Antibody FDA Approval 130

Pharmaceutical Technology

JUNE 14, 2023

The US Food and Drug Administration (FDA) has granted fast track designation for CellCentric’s inobrodib (CCS1477) to treat relapsed or refractory multiple myeloma patients. It inhibits p300 and CBP by binding into the conserved bromodomain of the twin proteins.

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Protein Antibody Gene Trials 243

Pharmaceutical Technology

JANUARY 25, 2023

French biopharmaceutical firm Poxel has received orphan drug designation (ODD) from the European Commission (EC) for its molecules PXL770 and PXL065 to treat adrenoleukodystrophy (ALD). PXL770 is a new, first-in-class direct activator of adenosine monophosphate-activated protein kinase (AMPK).

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Pharmaceutical Technology

MAY 9, 2023

FibroGen has signed an exclusive licence agreement with Fortis Therapeutics for the FOR46 antibody-drug conjugate (ADC) that targets a new epitope on CD46, a protein-coding gene. FOR46 is currently being investigated in a Phase I trial as a potential treatment for metastatic castration-resistant prostate cancer (mCRPC).

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Scienmag

FEBRUARY 23, 2021

(February 23, 2021) – The Gates Biomanufacturing Facility (GBF) has completed the manufacturing and release of a protein-based biologic under Good Manufacturing Practice for Phase 1 Investigational Drugs for first-in-human clinical trials.

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Protein Manufacturing Clinical Trials Clinical Trials 57

STAT News

DECEMBER 10, 2022

NEW ORLEANS — Researchers had hoped in recent years that a protein called GPRC5D might offer a new way to get the immune system to hunt down and destroy multiple myeloma cells. Now, the results of a Phase 2 study on a bispecific antibody targeting this protein offers confirmation.

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Antibody Protein Trials Research 132

BioSpace

APRIL 1, 2021

One of the common research approaches to treating brain diseases such as Parkinson’s disease (PD) and Alzheimer’s disease (AD) is using antibodies designed to clear the accumulated misfolded proteins implicated in the diseases. To date, these drug trials have not been particularly successful at i.

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Protein Drug Trials Antibody Trials 74

Drug Discovery World

APRIL 3, 2024

In the last few years, immunotherapies like immune checkpoint inhibitors, vaccines and cell and gene therapies have revolutionised the treatment of cancer, and targeted drugs like monoclonal antibodies (mAbs), poly-ADP ribose polymerase (PARP) inhibitors and targeted protein degraders are also playing an important role.

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Drug Discovery World

MARCH 6, 2024

UK-based biotech SynaptixBio has secured a second Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA). Earlier last year the biotech successfully led a second round of investment, taking the total up to £13.2m ($16.7m), which will take it up to the start of in-human clinical trials later this year.

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