The FDA issued a draft guidance for industry aiming to clarify requirements relating to requests for orphan designation regarding a pediatric population of a common disease. Read More

Atreca Inc., of Redwood City, Calif., reported the publication of results in preclinical cancer research enabled by its Immune Repertoire Capture (IRC) technology. Read More

Aclaris Therapeutics Inc., of Malvern, Pa., said it started a phase II, open-label trial of ATI-50002, a topical JAK1/3 inhibitor, for the potential treatment of nonsegmental vitiligo of the face. The trial will evaluate the safety, tolerability and preliminary efficacy of ATI-50002 applied twice daily in 24 adult subjects. Read More

Northwest Biotherapeutics Inc., of Bethesda, Md., said it launched a general solicitation Regulation D offering to accredited investors, which will remain open for execution and subscription agreements until 5:30 p.m. EST Dec. 27, with closing expected Dec. 29. Read More

HONG KONG – Scientists at The Scripps Research Institute (TSRI) in Jupiter, Fla., have developed a new means of identifying promising new drug candidates from microbial natural products, using information stored in the genomes of the bacteria that produce them. Read More

DUBLIN and PERTH, Australia – Sensorion SA is teaming up with Cochlear Ltd. to explore the potential for combining drug therapy with cochlear implant surgery to improve patient outcomes. Read More

HONG KONG – Osaka, Japan-based Ono Pharmaceutical Co. Ltd. entered a license agreement with Bristol-Myers Squibb Co. for the development and commercialization of its compound, ONO-4578, a selective antagonist of EP4, a prostaglandin E2 (PGE2) receptor. Read More

LONDON – Orchard Therapeutics Ltd. has raised a massive – and oversubscribed – £85 million (US$113.5 million) series B round to fund the commercialization of rare disease gene therapy programs in-licensed from academic labs. Read More

Christmas came early for Aerie Pharmaceuticals Inc. with an FDA approval of Rhopressa (netarsudil) for open-angle glaucoma or ocular hypertension on Monday – or maybe call it an early Valentine's Day gift considering the PDUFA goal date wasn't until Feb. 28, 2018. Read More

Spark Therapeutics Inc. turned the commercial corner with the FDA's nod for Luxturna (voretigene neparvovec-rzyl), which became the first gene therapy approved in the U.S. that targets an inherited disease, caused by mutations in a specific gene. Read More