pharmaphorum

FEBRUARY 22, 2021

Sanofi and GlaxoSmithKline are restarting clinical development of their COVID-19 vaccine, which was delayed after hitting a snag late last year. The vaccine is based around an adjuvanted recombinant protein, which will be tested in a new phase 2 study to assess the response including in older adults.

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Vaccine Vaccination Recombinant DNA Technology Trials 89

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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Marketing Trials Development Protein 147

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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Vaccine Vaccination RNA Clinical Trials 77

pharmaphorum

SEPTEMBER 18, 2020

Vertex is already the top player in CF with a quartet of exon-skipping medicines that tackle the mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that underlies the disease, but there are still a sizeable group of patients with no treatment options.

Gene Editing 105

Gene Editing Gene Vaccination Vaccine 105

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

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

Vaccine 59

Vaccine Vaccination Production Clinical Development 59

pharmaphorum

MARCH 9, 2021

Last year, Belgium’s ExeVir Bio raised 23 million euros ($27 million) to finance development of llama antibodies – and now it is ready to begin clinical development of a potential treatment that could be effective against emerging COVID-19 variants.

Antibody 98

Antibody Life Science Scientist Development 98

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

Vaccine 80

Vaccine Vaccination Manufacturing RNA 80

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.

Vaccine 98

Vaccine Vaccination Clinical Trials Clinical Trials 98

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.

Clinical Development 52

Clinical Development Development Drugs Protein 52

pharmaphorum

APRIL 26, 2022

There’s only one vaccine candidate for tick-borne infection Lyme disease in clinical development – Valneva and Pfizer’s VLA15 – and it has just moved another step closer to being available. There’s no guarantee of revenues for the COVID-19 shot from the UK however as the government there backed out of a $1.5

Vaccine 69

Vaccine Vaccination Bacteria Trials 69

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.

Gene Silencing 52

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.

Clinical Trials 59

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.

Vaccine 59

Vaccine Vaccination RNA Immune Response 59

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.

FDA Approval 105

FDA Approval Genetics Gene Therapy Gene 105

The Pharma Data

FEBRUARY 22, 2021

(Nasdaq: RIGL) today announced a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel’s R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases. vice president of immunology at Lilly.

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Development Clinical Development Clinical Trials Clinical Trials 40

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

Gene Therapy 96

Gene Therapy Gene Trials Development 96

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.

Drugs 52

Drugs Protein In-Vitro Development 52

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

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.

Drugs 52

Drugs Development Protein Clinical 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.

Gene Therapy 52

Gene Therapy Protein Clinical Development Gene 52

pharmaphorum

SEPTEMBER 8, 2021

The orally-active drug can be used in patients aged 12 and over after two other systemic therapies have been tried, and is thought to work by downregulating inflammatory immune cells and boosting the levels of T cells that help to regulate the immune system. KD033 is an anti-PD-L1/IL-15 fusion protein and is currently in a phase 1 trial.

Drugs 52

Drugs Sales Immune Response Marketing 52

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has granted Fast Track designation to VTX-801, Vivet’s clinical-stage gene therapy for the treatment of Wilson Disease – a rare, genetic disorder that reduces the ability of the liver and other tissues to regulate copper levels, causing severe hepatic damage, neurological symptoms, and potentially death.

Gene Therapy 52

Gene Therapy Gene Clinical Trials Clinical Trials 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.

Antibody 52

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.

Genetics 52

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.

Research 52

Research Trials Clinical Trials Clinical Trials 52

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

Gene Therapy 52

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

The Pharma Data

MARCH 26, 2021

Preclinical data suggest VIR-7831 targets a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop. GSK and Vir will continue discussions with the European Medicines Agency (EMA) and other global regulators to make VIR-7831 available to patients with COVID-19 as soon as possible.

Antibody 52

Antibody Trials Vaccination Vaccine 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.

Antibody 40

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.

Clinical Development 40

Clinical Development Antibody Development Production 40

The Pharma Data

JANUARY 13, 2021

TNX-1500 is a third generation anti-CD40-ligand mAb that has been designed by protein engineering to decrease Fc?RII CD40-ligand is a protein expressed on the surface of activated T lymphocytes that mediates T cell helper function. antagonist receptor fusion protein. RII, but had other issues, including decreased efficacy 3-5.

Antibody 52

Antibody Development Protein Vaccination 52

The Pharma Data

APRIL 12, 2022

vice president and global head of oncology clinical development at AbbVie. The BCL-2 family of proteins are known regulators of the apoptosis pathway.3 Disease control with reversal of bone marrow fibrosis is a key objective for improving patient outcomes,” said Mohamed Zaki, M.D.,

Trials 52

Trials Medicine Protein Clinical Development 52

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.

RNA 40

RNA Vaccine Vaccination 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