Drug Discovery World

APRIL 16, 2024

SEALS is a double-blind, randomised, placebo-controlled, multicentric Phase II study that will assess the efficacy, safety, tolerability and pharmacokinetics of NX210c treatment in ALS patients. The first results are expected by early 2026.

Clinical Trials 130

Clinical Trials Trials Drugs Pharmacokinetics 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

Drug Discovery World

FEBRUARY 23, 2024

Voyager Therapeutics has announced new data from its two preclinical programmes targeting pathological tau for the treatment of Alzheimer’s disease. Based on these data, Voyager has advanced this programme into late research and expects to file an investigational new drug (IND) application in 2026.

Therapies 130

Therapies Pharmacokinetics RNA International 130

Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Clinical application Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma CBER Final By 12/31/24 CBER CY 2024 Guidance Agenda Blood Considerations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method CBER Draft (..)

FDA 40

FDA Science Biosimilars Production 40

The Pharma Data

SEPTEMBER 15, 2020

27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. The prophylactic steroid treatment was also changed from 1 mg/kg to an intermediate dose of 2mg/kg. The most frequent treatment-emergent adverse events were nasopharyngitis and atopic dermatitis.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52