2004, Licensing and Therapies - Drug Discovery Digest

Saphnelo (anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus

The Pharma Data

AUGUST 1, 2021

AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. 2,3 TULIP-2 demonstrated superiority across multiple efficacy endpoints versus placebo with both arms receiving standard therapy.

Trials

Trials Therapies Disease Treatment

Scaling Phage Therapy

Codon

FEBRUARY 13, 2024

Tom Ireland writes about the companies and technologies that are reimagining phage therapy. Soon after its publication, scientists, journalists, and investors were revisiting ‘phage therapy’ as a promising alternative to our failing antibiotics. Read it on our website here. Illustration by David S. Fast forward to 2023.

Therapies

Therapies DNA Virus Clinical Trials

First patients dosed in Phase 1a clinical trial of UCL-backed G-Quadruplex (G4) targeting treatment for solid tumors, including pancreatic cancer

Sygnature Discovery

NOVEMBER 29, 2023

Following on from their exclusive license agreement with UCL in January 2022, subsequent preclinical and clinical development was undertaken by Qualigen Therapeutics Inc. Since 2004, Sygnature Discovery has delivered over 40 novel pre-clinical and 22 clinical compounds, with its scientists named on over 170 patents.

Clinical Trials

Clinical Trials Treatment Trials Small Molecule

First patients dosed in Phase 1a clinical trial of UCL-backed G-Quadruplex (G4) targeting treatment for solid tumors, including pancreatic cancer

Sygnature Discovery

NOVEMBER 29, 2023

Following on from their exclusive license agreement with UCL in January 2022, subsequent preclinical and clinical development was undertaken by Qualigen Therapeutics Inc. Since 2004, Sygnature Discovery has delivered over 40 novel pre-clinical and 22 clinical compounds, with its scientists named on over 170 patents.

Clinical Trials

Clinical Trials Treatment Trials Small Molecule

Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19

The Pharma Data

JULY 23, 2021

The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process. We also continue to identify, develop and support potential therapies which can play a role in treating the disease. The impact of COVID-19 goes beyond those who contract it.

Treatment

Treatment Virus Clinical Trials Pharmaceuticals

Tonix Pharmaceuticals Announces Publication of Patent Application for TNX-1500 (Monoclonal Antibody Anti-CD40-Ligand) in Development for Preventing and Treating Organ Transplant Rejection and Treating Autoimmune Conditions

The Pharma Data

JANUARY 13, 2021

Dr. Lederman continued, “Despite the recognized promise of anti-CD40-ligand mAb therapy, first generation anti-CD40-ligand mAbs were limited because their crystallizable fragment (Fc) domain interacted with a cell surface receptor called Fc?RII, 11):1583 (2004) 6 Karpusas M, et al. 175:1091-1101 (1992) 2 Karpusas, M et al.,

Pharmaceuticals

Pharmaceuticals Small Molecule Vaccine Protein Expression

New phase III data shows investigational antibody cocktail casirivimab and imdevimab reduced hospitalisation

The Pharma Data

MARCH 22, 2021

New infections continue to rise globally with over three million reported cases last week, so this investigational antibody cocktail may offer hope as a potential new therapy to high-risk patients – particularly in light of recent evidence showing that casirivimab and imdevimab together retain activity against key emerging variants.

Clinical Trials

Clinical Trials Virus Trials FDA

Athersys Announces Three Appointments to Board of Directors

The Pharma Data

NOVEMBER 15, 2020

This prestigious group of professionals will help lead the Company as it prepares for potential commercialization of its investigational cell therapy, MultiStem ®. MultiStem therapy’s potential for multidimensional therapeutic impact may distinguish it from traditional biopharmaceutical therapies focused on a single mechanism of benefit.

Clinical Trials

Clinical Trials Trials Production Therapies

DARPA Neurotechnology: The Deep Dive

Codon

MARCH 28, 2023

” By 2004, DARPA entered what might be reasonably called the “Ling/Kruse Era” Around this time, a program manager named Dr. Geoff Ling started what we think is the most highly-funded DARPA neurotechnology project to date: Human Assisted Neuro Devices, or HAND, with at least $150M in funding.

Engineering

Engineering Research Science FDA Approval

EMA issues advice on Lilly’s bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union

The Pharma Data

MARCH 5, 2021

of regulation 726/2004 provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies. The opinion can now be considered by the EU member states when making decisions on the use of the therapies at a national level before a formal marketing authorization is issued. Ricks, Lilly’s chairman and CEO.

Treatment

Treatment Hospitals Long-Term Care Facilities Therapies

The Codon Guide to Synthetic Biology

Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Progress in biology is arguably moving faster today than at any point in the course of human history. PNAS (2004). Engineered biology has profound potential to change how we live, but the field has become broad, bloated, nebulous. Current Genetics (2017). Science (2021).

DNA

DNA Cell Biology Molecular Biology Engineering

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

JULY 28, 2023

That law built upon several other previous laws, including the Public Health Threats and Emergencies Act of 2000, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project BioShield Act of 2004. Some of the affected former NDAs were approved using drug master files (DMFs).

FDA

FDA Science Biosimilars Regulations

The Codon Guide to Synthetic Biology

Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Last edit: 13 September 2023 Progress in biology is arguably moving faster today than at any point in the course of human history. PNAS (2004). Engineered biology has profound potential to change how we live, but the field has become broad, bloated, nebulous. Science (2021).

DNA

DNA Cell Biology Engineering Molecular Biology

Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. The plaintiffs’ causation allegations foundered in Himes because the treating physician did not believe that the claimed risks of electroconvulsive therapy were all that big of a deal, and thus did not warn about it. April 1, 2022) (the companion case to this ).

Testimonials

Testimonials Doctors Production Laboratories

Drug Discovery Digest

Saphnelo (anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus

Scaling Phage Therapy

Trending Sources

First patients dosed in Phase 1a clinical trial of UCL-backed G-Quadruplex (G4) targeting treatment for solid tumors, including pancreatic cancer

First patients dosed in Phase 1a clinical trial of UCL-backed G-Quadruplex (G4) targeting treatment for solid tumors, including pancreatic cancer

Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19

Tonix Pharmaceuticals Announces Publication of Patent Application for TNX-1500 (Monoclonal Antibody Anti-CD40-Ligand) in Development for Preventing and Treating Organ Transplant Rejection and Treating Autoimmune Conditions

New phase III data shows investigational antibody cocktail casirivimab and imdevimab reduced hospitalisation

Athersys Announces Three Appointments to Board of Directors

DARPA Neurotechnology: The Deep Dive

EMA issues advice on Lilly’s bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union

The Codon Guide to Synthetic Biology

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

The Codon Guide to Synthetic Biology

Unimpressed Learned Intermediaries Defeat Warning Causation

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