Drug Target Review

SEPTEMBER 10, 2024

Drug developer companies across the pharma industry report notable reductions in drug development timelines where 10 to 12 months, from lead monoclonal antibody (mAb) identification to IND application, is the new norm and in which earlier Tox material generation has been a critical component for shortening IND timelines.

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The Pharma Data

JANUARY 13, 2021

CD40-ligand is a protein expressed on the surface of activated T lymphocytes that mediates T cell helper function. 175:1091-1101 (1992) 2 Karpusas, M et al., International Immunol. (11):1583 11):1583 (2004) 6 Karpusas M, et al. Structure. 9(4):321-9. About CD40-Ligand.

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Pharmaceuticals Small Molecule Vaccine Protein Expression 52

The Pharma Data

DECEMBER 29, 2020

(NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ® plant cell-based protein expression system, and Chiesi Global Rare Diseases , a business unit of Chiesi Farmaceutici S.p.A.,

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Clinical Trials Disease Treatment Trials 52

The Pharma Data

OCTOBER 28, 2020

In almost all cases of Angelman syndrome, the maternal UBE3A allele is either missing or mutated, resulting in limited to no protein expression. Angelman syndrome is not a degenerative disorder, but the loss of the UBE3A protein expression in neurons results in abnormal communications between neurons.

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Protein Expression Therapies Treatment Disease 40

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Where vector presence is detected, transgene mRNA and/or protein expression levels should also be measured. Section #3: Human Trials Finally, the guidance provides a quick overview of clinical study recommendations. For cell therapy products, the draft guidance notes that in vivo imaging techniques provide certain advantages.

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The Pharma Data

JANUARY 15, 2021

3 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast, gastric, lung and colorectal cancer. About the Enhertu Clinical Development Program. 2,5 In the U.S., Approximately one in five gastric cancers are HER2 positive.3 Enhertu (6.4

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Treatment Trials Disease Therapies 52

The Pharma Data

SEPTEMBER 22, 2020

Trial design and other details are being evaluated and a comprehensive update on the overall Novartis SMA clinical development program will be provided at a future time following further discussions with health authorities. This guidance provides clarity on the path to registration for AVXS-101 IT.

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Clinical Development Therapies Clinical Trials Treatment 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 Trials Disease Therapies 52

Conversations in Drug Development Trends

MAY 30, 2024

Differences in regulatory sentiments and industry sponsors’ subsequent clinical development strategies historically restricted access based on geography.

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Treatment Clinical Trials Small Molecule Therapies 81

The Pharma Data

SEPTEMBER 2, 2020

Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, suggesting that important functions of the immune system may be preserved. The Phase III clinical development programme for ENSPRYNG includes two studies: SAkuraStar and SAkuraSky.

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Clinical Trials Disease Treatment Therapies 52

The Pharma Data

AUGUST 9, 2021

Enhertu is being further assessed in a comprehensive clinical development programme evaluating efficacy and safety across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers. 1 More than two million patients with breast cancer were diagnosed in 2020, resulting in nearly 685,000 deaths globally.

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Trials Treatment Clinical Trials Protein Expression 52

The Pharma Data

OCTOBER 26, 2020

Based on these promising findings, Transgene intends to continue the clinical development of TG4001 in a larger, controlled confirmatory study as we look to provide a better treatment option for this patient population,” added Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene. Conclusions.

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