Pharmaceutical Technology

JANUARY 2, 2023

Lifirafenib maleate is under clinical development by BeiGene and currently in the Phase II in clinical pathway. It seeks to work in partnership with academia, biotechnology and pharmaceutical companies to develop treatments for cancer patients.

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Drugs Development Clinical Trials Clinical Trials 100

pharmaphorum

APRIL 19, 2021

The French pharma just signed a deal with C4XD to develop drugs that could lead to oral medicines for inflammatory diseases such as psoriasis, as big pharma looks for more patient-friendly alternatives to therapies based on injections of antibody-based drugs. It spotlighted the UK as a place to do clinical development.

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pharmaphorum

APRIL 7, 2021

billion DKK ($672 million) from AbbVie after the companies struck an R&D deal to research epcoritamab, a bispecific antibody targeting CD3 and CD20 that the biotech developed in-house. Genmab has four technology platforms to draw from, with the most established being bispecific antibodies which target two receptors at once.

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Antibody Life Science Development Drugs 91

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 Pfizer and BioNTech have a $1.95

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Vaccine Vaccination RNA Clinical Trials 77

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. These cause the body to produce antibodies that neutralise the SARS-CoV-2 virus in the event of an infection.

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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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Life Science Antibody In-Vivo In-Vitro 52

The Pharma Data

JANUARY 13, 2021

The patent application is titled “Anti-CD154 Antibodies and Uses Thereof” and published under International Publication No. WO 2021/001458 A1. If claims are granted, a patent issuing from a national stage of this application could potentially provide U.S. Tonix’s President and Chief Executive Officer, Seth Lederman, M.D.

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Antibody Development Protein Vaccination 52

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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Development Antibody Clinical Development FDA Approval 52

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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Drugs Licensing Licensing Trials 75

XTalks

NOVEMBER 20, 2023

PI3K/AKT is a key intracellular signaling pathway that regulates cell survival and proliferation. The clinical development of PI3K and AKT inhibitors has proven to be more challenging than expected. Alterations in genes in the PI3K family lead to aberrant activation of the pathway to enhance cancer cell survival.

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HR FDA Approval Gene Trials 98

pharmaphorum

DECEMBER 11, 2020

Sanofi and GlaxoSmithKline have said their COVID-19 vaccine has hit a snag in clinical development, prompting analysts to note this could delay delivery of potentially more than a billion shots globally by up to nine months.

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Immune Response Trials Vaccine Vaccination 72

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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Containment Clinical Development Antibody Development 52

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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Vaccine Vaccination RNA Immune Response 59

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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FDA Approval Drugs Trials Clinical Trials 89

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

MARCH 26, 2021

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation. About COMET-ICE.

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Antibody Trials Vaccination Vaccine 52

The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

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FDA Approval Antibody Clinical Trials Clinical Trials 52

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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FDA Approval Clinical Development Allergies Development 52

The Pharma Data

OCTOBER 26, 2020

On 14 May 2018, the Company announced a collaboration with GlobalCo to work on its CDX antibody. This work complements the Company’s own development work currently being undertaken. This additional extension of the collaboration will allow us to choose the best CDX antibody for pre-clinical and clinical development.”

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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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Genetics Gene Antibody Development 52

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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Antibody Trials Drugs Development 52

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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Antibody Gene Therapy Containment Clinical Trials 40

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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Clinical Development Antibody Development Production 40

XTalks

APRIL 12, 2021

Currently being tested in the Phase 1/II PROPEL trial — announced in June 2019 — PR001 is the company’s first compound and is being developed to treat patients with Parkinson’s disease with confirmed mutations in the GBA1 gene (PD-GBA). According to Neuropore’s pipeline page, both UCB0599 and NPT520-34 remain in Phase I clinical development.

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Gene Therapy Gene Trials Development 96

The Pharma Data

MAY 7, 2021

GSK and Vir continue discussions with global regulators to make sotrovimab available to patients with COVID-19. Sotrovimab is also under review by other global regulators including Health Canada under the expedited Interim Order application pathway for COVID-19 drugs. About the Sotrovimab Clinical Development Program.

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Antibody Trials Vaccination Vaccine 40

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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Drugs Marketing Sales FDA Approval 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

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Gene Therapy Research Gene Antibody 52

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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Clinical Trials Clinical Trials Vaccine Vaccination 52

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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Development Gene Therapy Engineer Life Science 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

SEPTEMBER 9, 2020

Food and Drug Administration (FDA) for adults with anti-aquaporin-4 (AQP4) antibody positive NMOSD. This effect was more pronounced in aquaporin-4 antibody (AQP4-IgG) seropositive patients, who tend to experience a more severe disease course, with 66% reduction in risk of relapse (HR, 0.34; 95% CI, 0.19–0.62; Europe and Japan.

Antibody 52

Antibody Medicine In-Vitro HR 52

The Pharma Data

MAY 18, 2021

If approved, ENSPRYNG will be the first and only treatment available to both adults and adolescents from 12 years of age with anti-aquaporin-4 antibody (AQP4-IgG) seropositive NMOSD in the EU. AQP4-IgG antibodies are detectable in the blood serum of around 70-80% of people with NMOSD.

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Antibody Medicine In-Vitro Development 40

The Pharma Data

AUGUST 1, 2021

Saphnelo is a first-in-class type I interferon receptor antibody and the only new medicine in over a decade for patients with systemic lupus erythematosus . Saphnelo Saphnelo (anifrolumab) is a fully human monoclonal antibody that binds to subunit 1 of the type I IFN receptor, blocking the activity of type I IFNs. 7,8,9,10,11.

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Trials Clinical Development Antibody Medicine 52

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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Clinical Trials Clinical Trials Antibody Trials 52

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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