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. Read More
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. Read More
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. Read More
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. Read More
Reflecting a record-high workload at the FDA's drug center, the reconstructed PDUFA fees for fiscal 2018 will have to generate more than $911 million in revenue over the next year. Read More
Bayer AG's P13K inhibitor, copanlisib, won FDA approval Thursday for use in adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. Read More
Swept ahead of schedule by a summer protocol amendment, a positive phase III trial of Xtandi in men with early stage CRPC is now providing key evidence that could back their inclusion in the drug's label. Long desired by Astellas Pharma Inc. and Pfizer Inc. Read More
