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. Read More
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. Read More
Spark Therapeutics Inc., of Philadelphia, launched a public offering to raise $300 million. The firm intends to grant underwriters the option to purchase up to an additional 15 percent of the shares of common stock offered in the public offering. Read More
The U.S. Patient-Centered Outcomes Research Institute reported this week that it has awarded more than $3 million for 83 new projects through its Pipeline to Proposal Awards program. Read More
An Australian study reported in the Aug. 2, 2017, edition of Science Translational Medicine has identified a promising new potential target in preclinical models of triple-negative breast cancer (TNBC) and human epidermal growth factor receptor 2 (HER2)-amplified breast cancer (BC). Read More
The FDA Reauthorization Act (FDARA) of 2017 sailed through a final Senate vote of 94-1 despite a drawn-out cloture vote, but several amendments were added to H.R. 2430 by unanimous consent, including a right-to-try bill and a bill that would require the Department of Health and Human Services to develop a standard for "prominently displaying" information related to a patient's opioid addiction history in electronic health records. Read More
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. Read More
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. Read More
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. Read More
