Drug Discovery World

SEPTEMBER 6, 2022

DDW Editor Reece Armstrong looks at the cell and gene therapy landscape, examining the challenges facing developers and the trends we can expect to see throughout the year. . There’s no doubt that cell and gene therapies present some of the most exciting opportunities for emerging drugs. million price point per dose.

Therapies 130

Therapies Clinical Trials Vaccine Disease 130

Drug Discovery World

AUGUST 21, 2023

Medications containing semaglutide such as Ozempic, licensed for diabetes, and Wegovy, for weight loss, are being studied to see if they can treat a range of different conditions, including addiction and dementia. The drugs are currently approved as treatments for type 2 diabetes and weight loss.

Clinical Trials 130

Clinical Trials Trials Treatment Licensing 130

Agency IQ

AUGUST 16, 2024

Many commenters took issue with the guidance’s statement that, “The contribution of the psychotherapy component to any efficacy observed with psychedelic treatment has not been characterized. In the clinical studies, this consisted of a four-month course of treatment with three doses of MDMA administered in supervised therapy sessions.

FDA 40

FDA Trials Regulations Therapies 40

Agency IQ

AUGUST 2, 2024

While this would not affect existing vouchers, it would prevent FDA from issuing new ones after September 2026. FDA September 30 Deadline for submission of Advancing RWE Pilot Program projects A semi-annual deadline for FDA’s Advancing Real-World Evidence Program is set for the end of the fiscal year.

FDA 40

FDA Science Regulations Biosimilars 40

Drug Discovery World

FEBRUARY 26, 2024

Reece Armstrong speaks to Kathryn Golden , SVP Technical Operations and Manufacturing, bit.bio, about novel technologies, and methods to manufacture human cells for therapies so more patients can access these treatments. Cell therapies have emerged as transformative and potentially curative treatments across a range of disease areas.

Therapies 130

Therapies Treatment Engineering Disease 130

The Pharma Data

DECEMBER 12, 2020

The medicine is approved in many countries for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH), atypical haemolytic uremic syndrome, generalized myasthenia gravis and neuromyelitis optica spectrum disorder. Rare diseases is a high-growth therapy area with rapid innovation and significant unmet medical need.

Regulations 75

Regulations International Disease Small Molecule 75

Codon

SEPTEMBER 29, 2024

It suggested that, in the future, certain classes of drugs, specifically genetic therapies, could be screened entirely virtually via models of life. At best, the corporations with the best models released weak versions to the public under non-commercial licenses. Of particular interest was how genetic therapies were delivered.

Engineering 125

Engineering Virus DNA Therapies 125