2006, Clinical Development, Drugs and Therapies

Targeting the immunotherapy potential of cytokines IL-12 and IL-18 with new advancements in protein engineering

Drug Target Review

JUNE 6, 2023

We are in an era of immuno-oncology (IO) revolution with many approved therapies now available to treat a broad range of cancers. For the last several years, the field has worked to unlock the potential of IO therapies for additional tumour types, and has explored options beyond checkpoint inhibitors.

Engineering

Engineering Immune Response Biochemical Pharmacology Clinical Trials

Metabolism of macrocyclic drugs

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. However, in the quest to tackle challenging disease targets with difficult drug binding sites, there is revived interest in developing this compound type to offer unique solutions.

Metabolic Stability

Metabolic Stability Drugs FDA Approval Treatment

Metabolism of de novo designed macrocyclic drugs

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. However, in the quest to tackle challenging disease targets with difficult drug binding sites, there is revived interest in developing this compound type to offer unique solutions.

Metabolic Stability

Metabolic Stability Drugs FDA Approval Treatment

Multiple Dynamic Endpoints and the Role of Endpoint Adjudication Committees in Clinical Trials

Advarra

FEBRUARY 24, 2023

How do you know your experimental therapy is working? Sometimes, it can be as simple to determine as comparing drug A to placebo and measuring the physiological result with an approved assay. All key questions to consider and address before the therapy even leaves the lab.

Clinical Trials

Clinical Trials Trials FDA Therapies

CNS Pharmaceuticals Announces FDA Approval of IND Application for its Brain Cancer Drug Candidate Berubicin

The Pharma Data

DECEMBER 16, 2020

The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy. The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy.

FDA Approval

FDA Approval FDA Pharmaceuticals Clinical Trials

Update on US Regulatory Review of Roxadustat in Anemia of Chronic Kidney Disease

The Pharma Data

DECEMBER 18, 2020

18 December 2020 — The US Food and Drug Administration (FDA) has requested further clarifying analyses of clinical data, to complete its review of the New Drug Application (NDA) for roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for patients with anemia of chronic kidney disease (CKD).

Disease

Disease FDA FDA Approval Science

BioSpace Movers & Shakers, Nov. 6

The Pharma Data

NOVEMBER 5, 2020

Velders is presently chairman of HollandBIO, the association of Dutch biotech companies, and provides years of experience, specifically in the cell and gene therapy areas. acousia Therapeutics – Jonas Dyhrfjeld-Johnsen joined Germany-based Acousia in the new role of chief development officer.

Analytical Chemistry

Analytical Chemistry Pharmaceuticals Small Molecule Therapies

FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD)

The Pharma Data

AUGUST 16, 2020

First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology. Approval supported by one of the largest clinical trial programmes undertaken for this rare disease. In the SAkuraStar monotherapy study’s AQP4 antibody positive subgroup, 76.5%

FDA Approval

FDA Approval FDA Clinical Trials Treatment

New data show Roche’s ENSPRYNG (satralizumab) significantly reduces severity and risk of relapse in neuromyelitis optica spectrum disorder (NMOSD)

The Pharma Data

SEPTEMBER 9, 2020

Food and Drug Administration (FDA) for adults with anti-aquaporin-4 (AQP4) antibody positive NMOSD. The patients treated with ENSPRYNG were also less likely to require rescue therapy for a relapse compared with placebo (OR 0.46; 95% CI, 0.25–0.86, ENSPRYNG has been designated as an orphan drug in the U.S., 0.86, p=0.015).

Treatment

Treatment Disease Therapies FDA

OKYO Pharma Limited (“OKYO” or the “Company”) – OKYO announces filing of a patent application covering the use of Chemerin and associated analogues to treat “cytokine storm” associated with COVID-19 and ARDS

The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. Ranibizumab and other anti-VEGF agents have had a dramatic impact on the development of therapies for these blinding disorders.

Science

Science Virus FDA Approval Treatment

Cytokinetics Regains Rights to Develop and Commercialize Omecamtiv Mecarbil and AMG 594 From Amgen

The Pharma Data

NOVEMBER 22, 2020

We believe this is an important pivot point and opportunity for our company, as we reclaim omecamtiv mecarbil following positive Phase 3 clinical trial results,” said Robert I. We believe we are well prepared to press forward given our strong balance sheet and pioneering leadership in the development of muscle-directed therapies.”.

Clinical Trials

Clinical Trials Licensing Licensing Trials

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

SEPTEMBER 15, 2023

FDA’s nonprescription advisors find no efficacy for phenylephrine This week, FDA’s Nonprescription Drugs Advisory Committee (NDAC) voted unanimously that current scientific data do not support the efficacy of oral phenylephrine as a nasal decongestant, aligning with FDA analysis — and re-analysis — of data.

Science

Science FDA Clinical Trials Pharmacy

The evolution of assays for immuno-oncology research

Drug Discovery World

FEBRUARY 15, 2023

Existing therapies have been focused on eliminating the cancer cells and/or on preventing its progression by using a combination of chemotherapy, radiotherapy, and surgical approaches. Evolution of such defence mechanisms can lead to multi-drug resistance, further disease progression, and cancer metastasis.

Research

Research Therapies Immune Response Clinical Trials

Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Agency IQ

JUNE 9, 2023

FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity Late last week the FDA released a final guidance document containing recommendations on the nonclinical assessment of potential immunotoxicity for drugs and certain biologics.

FDA

FDA Science Small Molecule Immune Response

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1

The Pharma Data

NOVEMBER 24, 2020

Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients. Injection site reactions (ISRs) were the most common drug-related adverse reaction.

FDA Approval

FDA Approval Treatment FDA RNA

Drug Discovery Digest

Targeting the immunotherapy potential of cytokines IL-12 and IL-18 with new advancements in protein engineering

Metabolism of macrocyclic drugs

Trending Sources

Metabolism of de novo designed macrocyclic drugs

Multiple Dynamic Endpoints and the Role of Endpoint Adjudication Committees in Clinical Trials

CNS Pharmaceuticals Announces FDA Approval of IND Application for its Brain Cancer Drug Candidate Berubicin

Update on US Regulatory Review of Roxadustat in Anemia of Chronic Kidney Disease

BioSpace Movers & Shakers, Nov. 6

FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD)

New data show Roche’s ENSPRYNG (satralizumab) significantly reduces severity and risk of relapse in neuromyelitis optica spectrum disorder (NMOSD)

OKYO Pharma Limited (“OKYO” or the “Company”) – OKYO announces filing of a patent application covering the use of Chemerin and associated analogues to treat “cytokine storm” associated with COVID-19 and ARDS

Cytokinetics Regains Rights to Develop and Commercialize Omecamtiv Mecarbil and AMG 594 From Amgen

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

The evolution of assays for immuno-oncology research

Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1

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