pharmaphorum

NOVEMBER 12, 2020

The companies said deliveries of an initial order of 200 million vaccines will be subject to approval by European regulators and are expected to start by the end of this year. The Pfizer/BioNTech vaccine is based on mRNA, which instructs the body to produce the “Spike” protein on the surface of the SARS-CoV-2 coronavirus that causes COVID-19.

Vaccination 105

Vaccination Vaccine Manufacturing Regulation 105

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.

Vaccination 59

Vaccination Vaccine Production Clinical Development 59

pharmaphorum

NOVEMBER 17, 2020

The vaccine developed in partnership with Germany’s BioNTech has been shown to be 90% effective in clinical trials. The company has picked four US states – Rhode Island, Texas, New Mexico and Tennessee, to trial a delivery programme that aims to overcome this challenge. Pfizer and BioNTech have a $1.95

Vaccination 77

Vaccination Vaccine RNA Clinical Trials 77

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. The study is one of the largest DMD Phase III trials to date. The global incidence of DMD is approximately one in every 3,500 to 6,000 male births.

FDA Approval 105

FDA Approval Genetics Gene Therapy Gene 105

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

Vaccination 69

Vaccination Vaccine Bacteria Trials 69

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. In the case of a rolling review, the EMA evaluates trial data as they become available before a complete filing is submitted.

Vaccination 59

Vaccination Vaccine RNA Immune Response 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. NVX-CoV2373 is being studied in two ongoing pivotal phase 3 clinical trials: in the United States and Mexico, as well as in the UK for the prevention of COVID-19.

Vaccination 80

Vaccination Vaccine Manufacturing RNA 80

pharmaphorum

NOVEMBER 9, 2020

The companies said they will be ready to file the vaccine with the FDA in the third week of November once they have enough safety data to meet the regulator’s requirements. Top-line results come from a phase 3 trial of the candidate known as BNT162b2 and an evaluation of 94 cases from the trial of 43,538 patients.

Vaccination 98

Vaccination Vaccine Clinical Trials Clinical Trials 98

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

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

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

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.

Containment 52

Containment Clinical Development Antibody Development 52

Drug Discovery World

DECEMBER 27, 2023

Ng is working on critical challenges in clinical trials, specifically in planning and recruitment, and has been building innovative solutions designed to benefit patients and researchers – with a focus on efficiency, transparency and diversity in clinical development. Listen here. Listen here.

Clinical Trials 69

Clinical Trials Clinical Trials Drugs Development 69

pharmaphorum

APRIL 15, 2021

Roche’s Genentech unit has released further data from a key trial of Evrysdi, its oral treatment for spinal muscular atrophy (SMA), the rare muscle wasting disease that is often fatal in babies that develop it. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics.

Gene Therapy 52

Gene Therapy Protein Clinical Development Regulation 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

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

Drug Discovery World

MARCH 2, 2023

Positive early signs for precision cancer therapies In the first presentation, Dr Fiona McLaughlin, CSO, provided an update on Avacta’s oncology candidates that are currently in clinical development. The company anticipates the drug will enter Phase I clinical trials in 2024.

Trials 52

Trials Development Genetic Analysis Drugs 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

The Pharma Data

APRIL 12, 2022

AbbVie (NYSE: ABBV) today announced new data from a Phase 2 trial of navitoclax in combination with ruxolitinib in patients with myelofibrosis. 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

Trials 52

Trials Medicine Protein Clinical Development 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

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 52

Trials In-Vitro Insulin Protein 52

Drug Discovery World

AUGUST 24, 2023

The Phase I clinical trial of VENT-02, an oral, brain-penetrant NLRP3 inhibitor from Ventus Therapeutics, has launched with the dosing of the first patient. Ventus expects preliminary results from the trial in the first half of 2024. NLRP3 is the best understood member of a family of proteins known as inflammasome receptors.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Protein 52

The Pharma Data

JANUARY 13, 2021

we determined the crystal structure of CD40-ligand 2 , developed a humanized version of our antibody (hu5c8, ruplizumab, or Antova®) and tested it in human trials for preventing organ transplant rejection and autoimmunity. TNX-1500 is a third generation anti-CD40-ligand mAb that has been designed by protein engineering to decrease Fc?RII

Antibody 52

Antibody Development Protein Vaccination 52

The Pharma Data

JANUARY 25, 2021

The AD-SAB will work closely with NervGen as the Company plans its upcoming preclinical studies and clinical trials and in the analyses of the results from these studies. The Company is developing drugs for the treatment of multiple sclerosis, spinal cord injury and Alzheimer’s disease. Inhibition of the PTP?

Clinical Development 40

Clinical Development Containment Development Research 40

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. In December interim phase 1/2 trial results showed the vaccine produced a lower immune response in older adults.

Vaccination 89

Vaccination Vaccine Recombinant DNA Technology Trials 89

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.

Protein 52

Protein Immune Response In-Vitro Regulation 52

The Pharma Data

JANUARY 4, 2021

Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis or programmed cell death. Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators.

Drugs 40

Drugs Development Protein Clinical Trials 40

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. ,

Clinical Development 40

Clinical Development Development Licensing Licensing 40

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.

Vaccination 52

Vaccination Vaccine Immune Response Containment 52

XTalks

APRIL 12, 2021

Like other neurodegenerative disorders, such as Alzheimer’s disease and dementias, Parkinson’s disease research has been immensely challenging for biotechs, with a high rate of late-stage attrition in trials leading to a lack of disease-modifying therapies being approved. Cellular accumulation of ?-synuclein Axovant Gene Therapies.

Gene Therapy 96

Gene Therapy Gene Trials Development 96

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

Drug Discovery World

AUGUST 21, 2023

Diana Spencer investigates therapies in clinical development for triple-negative breast cancer and asks what future treatments might look like. The regulator had already approved the combination treatment in advanced cancers the previous year. The addition of pembrolizumab was supported by further trial results in 2022.

Protein 52

Protein Trials Clinical Trials Clinical Trials 52

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. About AstraZeneca. AstraZeneca.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

Drug Discovery World

MARCH 6, 2024

Guiding neurological drug discovery and development to success The 20 years since the Human Genome Project has seen transformational advances in the molecular understanding of cancers and rare genetic diseases, leading to genetically informed, personalised selection of therapies and massively improved outcomes for many patients.

Genome 64

Genome Genomics Clinical Trials Clinical Trials 64

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials In-Vitro 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. Spinal Muscular Atrophy (SMA). Multiple Sclerosis (MS). Neuromyelitis Optica Spectrum Disorder (NMOSD). Roche will present five sets of data on adults living with NMOSD.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

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.

Development 40

Development Clinical Development Clinical Trials Clinical Trials 40