The FDA triggered another biosimilar first Thursday with its right-on-schedule approval of Amgen Inc.'s Mvasi.

Chimerix Inc., of Durham, N.C., appointed Heather Knight-Trent vice president of regulatory affairs.

Levicept Ltd., of Sandwich, U.K., started a phase I trial testing LEVI-04, a p75 neurotrophin receptor fusion protein, in healthy volunteers and osteoarthritis patients.

Sunovion Pharmaceuticals Inc., of Marlborough, Mass., said the FDA approved the supplemental NDA to expand the indication for its antiepileptic drug, Aptiom (eslicarbazepine acetate), to include treatment of partial-onset seizures in children and adolescents, ages 4 to 17.

Sophiris Bio Inc., of San Diego, said it entered a loan and security agreement with Silicon Valley Bank and may borrow up to $10 million in two term loans, with $7 million of that amount having already been accessed.

Nanology LLC's strategy is "almost like having a new molecular entity, in terms of the broadness of the intellectual property [IP] around it, but on a more streamlined path to potential approval" if safety and efficacy pan out, Marc Iacobucci, managing director of DFB Pharmaceuticals Inc. told BioWorld, with a nod to the 505(b)(2) regulatory pathway that the Fort Worth, Texas-based firm intends to trod.

The FDA may be under a congressional mandate to advance the use of real-world evidence in its regulatory decisions, but many of the obstacles in getting the patient data needed to generate that evidence are beyond the agency's reach.

Akcea Therapeutics Inc., of Cambridge, Mass., an affiliate of Ionis Pharmaceuticals Inc., said it filed a new drug submission (NDS) to Health Canada for volanesorsen, an investigational medicine for the treatment of familial chylomicronemia syndrome (FCS).

Moleculin Biotech Inc., of Houston, engaged Bioscience SA, a contract research organization based in Bydgoszcz, Poland, to prepare a proof-of-concept trial in Poland for Moleculin's WP-1220 in patients with cutaneous T-cell lymphoma. Moleculin has completed the IND-enabling studies and plans to make an application to the Polish regulators soon.

HONG KONG – A recent University of Hong Kong (HKU) study has discovered a novel non-antibiotic drug with potent efficacy against methicillin-resistant Staphylococcus aureus (MRSA), which represents a promising lead compound for development of anti-virulence drugs against S. aureus.