The Pharma Data

JANUARY 12, 2021

Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g. Graham earned an M.D., About Tiziana Life Sciences.

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The Pharma Data

OCTOBER 25, 2020

Company Confirms COVID-19 Antibody Home Test and Two Severity Triage Tests can be Submitted to U.S. SQI is accelerating the clinical development of its direct-to-consumer COVID-19 HOME Antibody Test, its COVID-19 RALI-dx Severity Triage Test and its COVID-19 RALI- fast Severity Triage Point-of-Care (POC) Test.

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pharmaphorum

DECEMBER 28, 2022

Biogen’s efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China’s InnoCare last year for $125 million upfront. Antibodies like Ocrevus also struggle to penetrate the CNS and hit MS at the site of the problem.

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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., In July 2020, the U.S. Source link.

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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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pharmaphorum

JUNE 7, 2021

Biogen and Eisai have defied the naysayers and secured an historic FDA approval for their amyloid-targeting antibody aducanumab as the first-ever disease-modifying treatment for Alzheimer’s disease.

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The Pharma Data

AUGUST 18, 2020

That roughly translates into $4 per dose, though the entire grant also covers funding for clinical development. The antibody titers started to increase after the second injection and further increased after the third injection, suggesting the need for a booster injection,” the researchers wrote in the study. “The government.

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The Pharma Data

APRIL 14, 2021

2 The use of Xolair across allergic asthma, CIU and nasal polyps is based on its well-established efficacy and safety profile and supported by a robust clinical development program, including 10 Phase III studies. Xolair is the only approved antibody designed to target and block immunoglobulin E (IgE). In the U.S.,

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XTalks

JANUARY 17, 2024

It was also very nice to see a lot of patients and advocacy groups involved in discussions with investigators and regulators to be part of clinical trial designs,” said Dr. Vidal. There were a range of therapies under discussion, from targeted therapies to advanced antibody-drug conjugates (ADCs) and cell and gene therapies,” he says.

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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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pharmaphorum

JUNE 14, 2021

GlaxoSmithKline has staked a claim to the fast-moving category of cancer therapies targeting the TIGIT immune checkpoint, agreeing a $2 billion plus licensing agreement with iTeos Therapeutics for an antibody candidate in early clinical development.

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The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — VBL Therapeutics (Nasdaq: VBLT), today announced that the European Patent Office (EPO) has granted Patent # 3328401 , which covers VBL’s proprietary investigational anti-MOSPD2 monoclonal antibodies to treat oncology conditions. TEL AVIV, Israel, Oct. About VBL Vascular Biogenics Ltd.,

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The Pharma Data

DECEMBER 12, 2020

Alexion ‘s franchise includes Soliris (eculizumab), a first-in-class anti-complement component 5 (C5) monoclonal antibody. More recently, Alexion launched Ultomiris (ravulizumab), a second-generation C5 monoclonal antibody with a more convenient dosing regimen.

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The Pharma Data

OCTOBER 18, 2020

Developed and marketed by Janssen, Tremfya (R) is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. The focus is on cancer. In July 2020, the U.S. References: 1. European Medicines Agency. Available at: www.medicines.org.uk/emc/medicine/34321.

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pharmaphorum

JANUARY 30, 2022

The US regulator has given the green light to the bispecific antibody – now called Vabysmo – for both neovascular or ‘wet’ age-related macular degeneration (AMD) and diabetic macular oedema (DME).

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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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The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Interim analysis from Phase 1/2a First-in-Human trial supports further clinical development of investigational vaccine candidate JNJ-78436735 (also known as Ad26.COV2.S).

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The Pharma Data

DECEMBER 17, 2020

Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinical development group. Immune Regulation – U.K.-based

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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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The Pharma Data

DECEMBER 15, 2020

On top of this, another 8 million carry auto-antibodies, blood molecules that indicate a person’s chance of developing an autoimmune disease. Many drug makers are investing in new science and hope to develop new therapeutics that address autoimmune disease. Monoclonal Antibodies. Bioelectronic Platform.

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pharmaphorum

MAY 14, 2021

This and its smaller size – it’s a “nanobody” that is only a fraction of the size of conventional antibodies – could allow it to penetrate deeper into the skin and joints. Since joining pharmaphorum he has written stories on topics including regulation, mergers and acquisitions, and the latest clinical developments.

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Roots Analysis

MAY 21, 2024

These are the vital structural component of cells, which help in cell functioning and regulation of building body tissues. However, continuous regulation of the cellular proteome is essential for maintaining the right balance of different proteins necessary for normal cellular function, survival, and proliferation.

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Delveinsight

AUGUST 17, 2020

million in 2019 and is anticipated to increase at a CAGR for the study period 2017-2030 owing to dynamic pipeline therapies in the mid-/ late-stage clinical development and rising gastroparesis prevalence. At present, Diet-regulation is one of the mainstays of gastroparesis treatment.

Marketing 54

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FDA Law Blog

NOVEMBER 2, 2023

Regarding screening for risk of liver injury: “Total and/or neutralizing antibody titers are screened in many clinical studies, but how such testing is performed, the cut-offs, and the acceptance criteria are all variables that may need standardization.” Consensus does not require unanimity, but a general agreement.

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VirTrial

JUNE 17, 2024

In this article we will be discussing some of the history of this disease and the efforts made to develop treatments as we have continued to understand Myasthenia Gravis and its underlying mechanisms better over time. Different Monoclonal Antibodies in Myasthenia Gravis: A Bayesian Network Meta-Analysis. Wang, Z., & Chen, G.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

VirTrial

JUNE 17, 2024

In this article we will be discussing some of the history of this disease and the efforts made to develop treatments as we have continued to understand Myasthenia Gravis and its underlying mechanisms better over time. Different Monoclonal Antibodies in Myasthenia Gravis: A Bayesian Network Meta-Analysis. Wang, Z., & Chen, G.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

VirTrial

JUNE 17, 2024

In this article we will be discussing some of the history of this disease and the efforts made to develop treatments as we have continued to understand Myasthenia Gravis and its underlying mechanisms better over time. Different Monoclonal Antibodies in Myasthenia Gravis: A Bayesian Network Meta-Analysis. Wang, Z., & Chen, G.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

Delveinsight

DECEMBER 24, 2020

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. Sosei and GSK will collaborate during the research and early preclinical development stages of the R&D process.

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The Pharma Data

OCTOBER 14, 2020

Potential Development of Human Monoclonal Antibody Therapeutics to SARS-CoV-2. The research is part of an ongoing collaboration between Columbia University and Tonix that focuses on T cell and antibody responses to SARS-CoV-2 (CoV-2), the virus that causes COVID-19. CHATHAM, N.J., Ilya Trakht, Ph.D.,

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The Pharma Data

NOVEMBER 10, 2020

First Ever Study with take-home capsules of Foralumab , a Fully Human Anti-CD3 Monoclonal Antibody. Phase1b/2 clinical study to be conducted in the United States and several European countries. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. Billion by 2025.

Life Science 40

Life Science Clinical Trials Clinical Trials Trials 40

pharmaphorum

APRIL 28, 2022

The new hub will focus on centralising things like clinical development strategy, clinical operations, and regulatory approval strategy – not necessarily drug development itself. How big pharma tackles rare diseases. But they also don’t have to invest in mass market advertising.

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The Pharma Data

SEPTEMBER 2, 2020

New Phase III data from SAkuraStar and SAkuraSky studies demonstrate reduced severity of relapses with ENSPRYNG (satralizumab), recently FDA-approved as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).

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Clinical Trials Clinical Trials Antibody Medicine 52

The Pharma Data

SEPTEMBER 16, 2020

Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C ?inhibitor Amgen, along with members of?Amgen’s inhibitor sotorasib (AMG 510). On Monday, Sept. 21 , at 1:00 p.m. PDT , David M. Reese , M.D.,

Production 52

Production Sales Clinical Trials Clinical Trials 52

VirTrial

JUNE 17, 2024

In this article we will be discussing some of the history of this disease and the efforts made to develop treatments as we have continued to understand Myasthenia Gravis and its underlying mechanisms better over time. Different Monoclonal Antibodies in Myasthenia Gravis: A Bayesian Network Meta-Analysis. Wang, Z., & Chen, G.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Antibody 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 Amgen, along with members of?Amgen’s inhibitor sotorasib (AMG 510). On Monday, Sept. 21 , at 1:00 p.m. PDT , David M. Reese , M.D.,

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The Pharma Data

OCTOBER 19, 2020

Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies. V114 was generally well tolerated in both studies, with a safety profile consistent with that observed for V114 in previously reported studies.

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The Pharma Data

SEPTEMBER 9, 2020

On July 27, Pfizer and BioNTech announced that following extensive review of preclinical and clinical data from Phase 1/2 clinical trials, and in consultation with the FDA’s Center for Biologics Evaluation and Research (CBER) and other global regulators, the companies selected the BNT162b2 vaccine candidate to move forward into a Phase 2/3 study.

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