Pacira Pharmaceuticals Inc. CEO David Stack said he didn't see "anything that causes us any great concern" in terms of a competitor for Exparel, the liposomal bupivacaine that sold $70 million in the second quarter, although not all analysts agree.
Jazz Pharmaceuticals plc is seeing the first concrete dividend of its $1.5 billion buyout of Celator Pharmaceuticals Inc. with FDA approval for Vyxeos (daunorubicin and cytarabine) for the treatment of adults with two types of high-risk acute myeloid leukemia (AML). It's the second new AML therapy approved this week, following Tuesday's approval of Idhifa (enasidenib) for certain adults with relapsed or refractory AML.
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., reported second-quarter U.S. sales of Eylea (aflibercept) totaling $919 million, up 11 percent over the second quarter of 2016.
Vaccibody AS, of Oslo, Norway, said it filed a clinical trial application for its cancer neoantigen vaccine, VB10.NEO, with German regulatory authority Paul Ehrlich Institute to run a phase I/IIa trial evaluating the safety, feasibility and efficacy of VB10.NEO in combination with standard-of-care checkpoint inhibitor therapy in patients with locally advanced or metastatic non-small-cell lung cancer, melanoma, renal cancer, bladder and head and neck cancer.
Aclaris Therapeutics Inc., of Malvern, Pa., submitted a marketing authorization application (MAA) to Sweden's Medicines Product Agency (MPA) for A-101, a topical high-concentration hydrogen peroxide formulation, for the treatment of seborrheic keratosis.
The FDA's Arthritis Advisory Committee (AAC) gave the agency a lot to chew on Wednesday as it voted 12-1 against recommending approval of Janssen Biotech Inc.'s sirukumab as a new tool in the rheumatoid arthritis (RA) armamentarium.
The FDA is releasing draft guidance on child-resistant packaging statements in the labeling of prescription and over-the-counter drugs. The guidance discusses the information that should be included to support the statements and to help ensure that the labeling is clear, useful, informative and, as much as possible, consistent in content and format, according to a notice slated for publication in Thursday's Federal Register. Comments on the guidance are due by Oct. 2.
Amplyx Pharmaceuticals Inc., of San Diego, said it raised $67 million through a series C financing led by Sofinnova Venture Partners, which included other new investors Lundbeckfonden Ventures, London-based Arix Bioscience plc and Pappas Capital, as well as existing investors New Enterprise Associates, RiverVest Venture Partners, 3×5 RiverVest II and BioMed Ventures.
RSS