Pharmaceutical Technology

JULY 18, 2022

There have recently, however, been some notable developments towards improving the care of bronchiectasis patients. These include the ongoing clinical development of AstraZeneca’s Fasenra (benralizumab), Insmed’s brensocatib and Novartis’ icenticaftor (QBW251).

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pharmaphorum

NOVEMBER 17, 2020

Pfizer is poised to file the vaccine with the FDA in the coming days, seeking an Emergency Use Authorization (EUA) after gathering enough safety data required by the regulator. The four states will not receive the vaccine earlier because of the pilot, according to Pfizer. Pfizer and BioNTech have a $1.95

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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. A further 1.8

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Vaccination Vaccine Production Clinical Development 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. Russia and China are also winning a “vaccine diplomacy” war by sending vaccines direct to Africa, while the G7’s wealthy nations build up stockpiles. US-based Novavax said the deal with Gavi covers 1.1

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Vaccination Vaccine Manufacturing RNA 80

pharmaphorum

FEBRUARY 19, 2021

Rigel’s clinical-stage R552 is the main asset in the deal – which also includes $835 million in development, regulatory, and commercial milestones – but Lilly has also taken rights to preclinical-stage follow-ups that can cross into the brain and may have potential in central nervous system disorders.

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pharmaphorum

NOVEMBER 18, 2021

RNAi uses small RNA molecules to bind to messenger RNA, which is responsible for synthesising proteins, and either destroy it or recruit other cellular factors that regulate its activity. Once in the blood, the GalXC molecules travel to the liver, where they enter hepatocyte cells and can switch protein production on or off.

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Gene Silencing RNA Protein Gene 52

pharmaphorum

AUGUST 3, 2022

The five-year-old Chinese company – which is developing drugs for age-related degenerative diseases – said it will use the proceeds of the Series B to support the clinical development of its RIPK1 inhibitors as well as to expand its pipeline of drug candidates in other classes.

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Clinical Trials Clinical Trials Drugs Protein 59

pharmaphorum

OCTOBER 6, 2020

The European Medicines Agency has begun a second “rolling review” of a potential coronavirus vaccine jointly developed by BioNTech and Pfizer, setting up a race with a rival from AstraZeneca and Oxford University. According to latest figures from the World Health Organization, there are 42 potential COVID-19 vaccines in clinical development.

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Vaccination Vaccine RNA Immune Response 59

The Pharma Data

JANUARY 10, 2021

PLANEGG / MUNICH, GERMANY / ACCESSWIRE / January 11, 2021 / MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR), a commercial-stage biopharmaceutical company and a leader in antibody, protein and peptide technologies, announced today that Jean-Paul Kress, M.D., Source link.

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Containment Clinical Development Antibody Development 52

The Pharma Data

JANUARY 31, 2021

Ion channels represent a large but under-exploited class of drug targets beyond G protein-coupled proteins (GPCRs). Ion channels are a class of integral membrane proteins that regulate the flow of ions across the cell membrane as a means of conducting signals between cells and their environment.

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The Pharma Data

MARCH 1, 2022

This acquisition gives AbbVie access to Syndesi’s portfolio of novel modulators of the synaptic vesicle protein 2A (SV2A), including its lead molecule SDI-118. It has been a pleasure to partner with our investors to investigate the potential of SDI-118 in early clinical studies.

Protein 52

Protein Licensing Licensing Development 52

pharmaphorum

APRIL 15, 2021

There are several treatment options now available for SMA, with Novartis’ ultra-pricey Zolgensma offering a one-off gene therapy, while Biogen’s antisense drug Spinraza instructs the body to produce a working version of the SMN protein that is the root cause of the disease. The study met its primary endpoint.

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Gene Therapy Protein Clinical Development Gene 52

The Pharma Data

NOVEMBER 2, 2020

2, 2020 — An experimental antibody drug that targets one of the body’s key metabolism regulators may help obese people lose weight — at least briefly. But the protein is cleared from the body too quickly to be useful, explained Arora, who was with biotech company Genentech at the time of the study. MONDAY, Nov.

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Antibody Drugs Hormones Insulin 52

The Pharma Data

JULY 6, 2021

GlaxoSmithKline plc (LSE/NYSE: GSK) and Alector (Nasdaq: ALEC), today announced a strategic global collaboration for the development and commercialisation of two clinical-stage, potential first-in-class monoclonal antibodies (AL001 and AL101) designed to elevate progranulin (PGRN) levels.

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Genetics Gene Antibody Development 52

Delveinsight

DECEMBER 24, 2020

GPR35 is a G protein-coupled receptor (GPCR) that was recognized in the late 1990s. Information on the function of GPR35 was slow to develop because of the issues, including an initial lack of ligands, which regulate the receptor, and the inability to study its function in rodent models.

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Delveinsight

AUGUST 20, 2020

regulator that had earlier told there was no requirement of an AdComm for the drug, aka, valrox, has issued a complete response (CRL) letter, which could cause a significant delay for any future approval, and canceled what would have been the first-ever approval for gene therapy in the bleeding disorder. J&J has agreed to pay USD 52.50

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Gene Therapy Research Gene Antibody 52

The Pharma Data

APRIL 8, 2021

Roche will present data from five studies from the EVRYSDI clinical development programme, which was designed to represent a broad spectrum of people living with SMA. The full range of data from Roche’s clinical development programme in neuroscience being presented at 2021 AAN include: Medicine and/or Therapeutic Area.

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Clinical Trials Clinical Trials Trials Antibody 52

The Pharma Data

OCTOBER 14, 2020

About VBL’s VB-600 Platform VBL is conducting two parallel drug development programs that are exploring the potential of MOSPD2 (motile sperm domain-containing protein 2), a protein that VBL has identified as a key regulator of cell motility, as a therapeutic target for inflammatory diseases and cancer.

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Antibody Gene Therapy Containment Clinical Trials 40

The Pharma Data

DECEMBER 29, 2020

(NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ® plant cell-based protein expression system, and Chiesi Global Rare Diseases , a business unit of Chiesi Farmaceutici S.p.A.,

Clinical Trials 52

Clinical Trials Clinical Trials Trials Protein 52

The Pharma Data

OCTOBER 18, 2020

About MorphoSys MorphoSys (FSE & NASDAQ: MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. References: 1. European Medicines Agency. emc/medicine/34321.

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Clinical Development Antibody Development Production 40

Roots Analysis

OCTOBER 30, 2023

These RNA based therapeutics play a crucial role in protein production and regulation of gene functions. Key players engaged in the development of self amplifying RNA based therapeutics include ( established before 2010, in alphabetical order ) Alphavax, GlaxoSmithKline, BioNTech and Pfizer.

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RNA Vaccination Vaccine Development 40

The Pharma Data

JANUARY 25, 2021

“The technology has a unique pharmacological profile, which is very different from other products in preclinical and clinical development in that it focuses on restoring function. The Company is developing drugs for the treatment of multiple sclerosis, spinal cord injury and Alzheimer’s disease. Corey Davis Ph.D.,

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Clinical Development Containment Development Research 40

The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. Brilacidin is a first-in-class Host Defense Protein (HDP) mimetic with antiviral, anti-inflammatory and antibacterial properties. Source link.

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Clinical Trials Clinical Trials Trials In-Vitro 52

The Pharma Data

OCTOBER 28, 2020

All patients experienced numerical increases in the sub-scale growth scores of expressive and/or receptive communication of the Bayley Scales of Infant and Toddler Development (Bayley-4) domains, and three patients showed improvements in the Observed Reported Communication Ability (ORCA) measure of expressive, receptive, and pragmatic communication.

Protein 40

Protein Production Development Drugs 40

The Pharma Data

DECEMBER 13, 2020

PXL770 is a first-in-class, oral direct adenosine monophosphate-activated protein kinase (AMPK) activator. AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. About PXL770.

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Trials In-Vitro Insulin Protein 40

The Pharma Data

DECEMBER 15, 2020

Scientists will be testing a drug class targeting the C-reactive protein (CRP) marker of acute inflammation in the body. The protein may be involved in such conditions, and a CRP test may be used to find or monitor conditions that cause inflammation. Treatment induced sustainable clinical responses and reduced systemic inflammation.

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Clinical Trials Clinical Trials Antibody Trials 52

The Pharma Data

OCTOBER 19, 2020

“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

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Vaccination Vaccine Immune Response Containment 52

The Pharma Data

JANUARY 18, 2021

About Chemerin and its receptor: The chemerin receptor (“CMKLR1”, also known as ChemR23) is a chemokine like G protein-coupled receptor (“GPCR”) expressed on select populations of cells, including inflammatory mediators (including macrophages, monocytes, plasmacytoid/myeloid dendritic cells and natural killer cells), as well as epithelial cells.

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Life Science Development Sales Drugs 40

The Pharma Data

SEPTEMBER 20, 2020

Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C ?inhibitor 1,2 Targeting the KRAS protein, the most commonly altered family member in solid tumors, has been one of the toughest challenges in cancer research.

Medicine 52

Medicine Production Sales Clinical Trials 52

The Pharma Data

OCTOBER 14, 2020

“This work may also guide the selection of appropriate participants for clinical trials of COVID-19 vaccines, including future human trials using Tonix’s TNX-1800, a live replicating, attenuated COVID-19 vaccine candidate designed to confer durable T cell immunity.”. About TNX-1800.

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Vaccination Vaccine Development Medicine 40

The Pharma Data

SEPTEMBER 2, 2020

Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, suggesting that important functions of the immune system may be preserved. The Phase III clinical development programme for ENSPRYNG includes two studies: SAkuraStar and SAkuraSky.

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Clinical Trials Clinical Trials Antibody Medicine 52

XTalks

APRIL 12, 2021

GBA1 encodes for beta-glucocerebrosidase (GCase), a lysosomal enzyme that is responsible for regulating the organelle’s ability to get rid of glycolipids. But just three months later, Voyager faced another stumbling block in the form of an FDA-mandated clinical hold on the trial. Cellular accumulation of ?-synuclein

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Gene Therapy Gene Trials Development 96

The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

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Clinical Development Development Licensing Licensing 40

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.

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Clinical Development Gene Therapy Development Gene 52

pharmaphorum

NOVEMBER 9, 2020

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. The independent data monitoring committee that conducted the interim analysis said that there had been no serious safety concerns identified.

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Vaccination Vaccine Clinical Trials Clinical Trials 98

XTalks

MARCH 28, 2024

Progressive muscle weakness in the disease is caused by genetic mutations in the dystrophin gene that lead to a lack of functional dystrophin protein. According to the FDA, life expectancy for those with DMD has increased over the years, with some patients surviving beyond 30 years.

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FDA Approval Genetics Gene Therapy Gene 105

The Pharma Data

DECEMBER 29, 2020

The expansion of the eligible stocks of Hong Kong Stock Connect, will further optimize the interconnected, intercommunicated, and mutual development of the capital markets between Mainland China and Hong Kong. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia, and China.

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