The Pharma Data

OCTOBER 28, 2020

Food and Drug Administration (FDA) prior to resuming enrollment and dosing. In almost all cases of Angelman syndrome, the maternal UBE3A allele is either missing or mutated, resulting in limited to no protein expression. Food and Drug Administration (FDA). About GeneTx Biotherapeutics.

Protein Expression 40

Protein Expression Therapies Treatment Disease 40

The Pharma Data

SEPTEMBER 2, 2020

Initiation of Phase III clinical trial programme for fenebrutinib, an investigational medicine designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, which may offer novel approach to suppress disease activity and slow disease progression in MS. ENSPRYNG is approved in the US, Canada, Japan and Switzerland.

Clinical Trials 52

Clinical Trials Disease Treatment Therapies 52

The Pharma Data

SEPTEMBER 22, 2020

Basel, September 23 , 2020 – Novartis Gene Therapies recently received feedback from the US Food and Drug Administration (FDA) following their review of data from the STRONG study of the intrathecal (IT) formulation of AVXS-101 in older patients with spinal muscular atrophy (SMA).

Clinical Development 52

Clinical Development Therapies Clinical Trials Treatment 52

The Pharma Data

JULY 21, 2021

Positive top-line results have already been reported for two Phase 2 clinical trials of VLA15 in over 800 healthy adults. VLA15 is the only active Lyme disease vaccine candidate in clinical development today, and covers six serotypes that are prevalent in North America and Europe. About VLA15.

Vaccine 52

Vaccine Disease Trials Protein Expression 52

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. Related Articles: Enhertu (fam-trastuzumab deruxtecan-nxki) FDA Approval History. 2,5 In the U.S.,

Treatment 52

Treatment Trials Disease Therapies 52

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. TNX-801 , live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox. 175:1091-1101 (1992) 2 Karpusas, M et al., International Immunol. (11):1583

Pharmaceuticals 52

Pharmaceuticals Small Molecule Vaccine Protein Expression 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. Initial approval in 1994: FDA, U.S. Initial approval in 2022: FDA, U.S. Initial approval in 2023: FDA, U.S. Then 1 packet to be used twice daily thereafter.

Treatment 81

Treatment Clinical Trials Small Molecule Therapies 81

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.

Vaccine 40

Vaccine Trials Treatment Virus 40