Hemispherx offers more data on Ampligen

Hoping to overcome the FDA's concerns regarding Ampligen, Hemispherx announced that it has submitted new preclinical data for the drug to regulators. The agency had rejected Ampligen after concluding that the studies Hemispherx had mounted for the drug had not provided conclusive evidence of the drug's efficacy as a treatment for chronic fatigue syndrome. The FDA recommended that Hemispherx mount a major new trial involving at least 300 patients. And that decision capped 20 years of work on the drug. Report

Suggested Articles

Half of patients in an early trial of Allogene's off-the-shelf CAR-T cells for lymphoma who received a higher dose of its antibody ALLO-647 responded.

Takeda is tossing out a Shire pipeline med after it couldn't find a buyer.

Ipsen's new hire arrives at a company reeling from a torrent six months that have crushed hopes for its $1 billion bet on a rare disease drug.