By Mary Jo Laffler
The January 2010 approval for Acorda Therapeutics Inc.'s oral multiple sclerosis therapy Ampyra (dalfampridine) is an impressive accomplishment –...
Welcome to In Vivo
Create an account to read this article
Already a subscriber?
The January 2010 approval for Acorda Therapeutics Inc.'s oral multiple sclerosis therapy Ampyra (dalfampridine) is an impressive accomplishment - by any account. The company took a drug that failed one development program and resurrected it so that it ultimately won FDA approval and is fast becoming a commercial success. Every drug and indication has its challenges, and gaining FDA approval is never simple. But Acorda's challenges were greater than most. MS causes demyelination, which leads to slower nerve conduction; gait problems are one of its most common symptoms. Acorda was first to tackle the walking problem, and it faced the challenge of proving a novel benefit in a disease that is highly debilitating, progressive, and variable. Patients can feel better one day, worse another, for reasons no one entirely understands, making it difficult to discern a drug's impact. Along the way, Acorda also had to contend with the usual complications: development setbacks, edgy investors and negotiations with FDA. To demonstrate that its new drug for walking impairment was efficacious, Acorda devised an innovative responder rate analysis, which used a novel endpoint and an unusual statistical analysis to identify subsets of responders.
By Mary Jo Laffler
The January 2010 approval for Acorda Therapeutics Inc.'s oral multiple sclerosis therapy Ampyra (dalfampridine) is an impressive accomplishment –...
Create an account to read this article
Already a subscriber?
Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.
Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access In Vivo, or if you love it how it is, now is the time to have your voice heard.
The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.
Despite recent political turmoil, outside investor and corporate interest in South Korean biopharma innovation appears robust or even increasing.
Agnès Arbat, CEO of Oxolife and winner of the EU Women Innovators Prize, joins In Vivo to discuss OXO-001, a novel non-hormonal treatment aimed at improving embryo implantation in IVF. She shares insights from her biotech journey and the future of fertility innovation.