Plus   Neg

Orchard Therapeutics: CHMP Adopts Positive Opinion For Libmeldy - Quick Facts

Orchard Therapeutics (ORTX) announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending full, or standard, marketing authorization for Libmeldy, an investigational gene therapy for the treatment of metachromatic leukodystrophy. A final decision by the European Commission for Libmeldy is expected before the end of 2020.

Orchard Therapeutics noted that, if approved, Libmeldy would be the first commercial therapy and first gene therapy for eligible patients with early-onset Metachromatic Leukodystrophy.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Santa Cruz Bicycles LLC has recalled certain model year 2020 bicycles with aluminum frames citing fall risks, according to the U.S. Consumer Product Safety Commission. The recall involves about 2,900 units of model year 2020 Auminum Santa Cruz and Juliana Bicycles. In addition, about 216 were sold in Canada. AstraZeneca is mulling an additional global trial to confirm the 90% efficacy rate of its Covid-19 vaccine candidate at lower dosage, Bloomberg news quoted Chief Executive Officer Pascal Soriot as saying. In an interview, Soriot noted that instead of adding the trial to an ongoing U.S. process, the company might launch a fresh study to evaluate efficacy of lower dosage of its vaccine that perform U.S. airline Delta Air Lines, Inc. and its Italian codeshare partner Alitalia are planning to launch quarantine-free, COVID-free flights between U.S. and Europe through new testing protocols, starting in December. In a statement, Delta said it has signed deals with airports and governments eliminating quarantine requirements on COVID-tested flights connecting Atlanta and Rome.
Follow RTT