Prothena Corp. plc, of Dublin, said it sold 2.7 million of its ordinary shares priced at $57.50 per share for gross proceeds of about $155.3 million. Read More
Batu Biologics Inc., of San Diego, disclosed the publication of mechanistic data for the Vallovax platform in the current issue of Oncotarget. Read More
TG Therapeutics Inc., of New York, said preliminary results of a phase II study of ublituximab, its glycoengineered anti-CD20 monoclonal antibody, showed that in patients with relapsing forms of multiple sclerosis it demonstrated rapid and robust B-cell depletion. Read More
Different platinum-based chemotherapies differed in their mechanisms of action, opening the door to rational combinations with other therapies. Read More
The FDA gave its nod to Milford, Penn.-based Serenity Pharmaceuticals LLC's Noctiva (desmopressin acetate) nasal spray for nocturnal polyuria (overproduction of urine during the night) in adults who awaken at least two times per night to urinate. It's the first FDA-approved treatment for that condition. Read More
A few lawmakers seized the first congressional hearing on the second rendition of the U.S. generic drug and biosimilar user fee agreements to frame their concerns about the administration's federal hiring freeze, regulatory crackdown and plans to replace the Affordable Care Act (ACA). Read More
LONDON – The FDA and EMA have signed a mutual recognition agreement (MRA) under which they will accept and rely upon the conclusions of each other's good manufacturing practice (GMP) inspections in their respective territories. Read More
DUBLIN – Sanofi SA is paying €120 million (US$127 million) up front and could pay up to €495 million more in development and commercial milestones for a 50 percent share in the economics of Astrazeneca plc's MEDI8897, a next-generation successor to its longstanding Synagis (palivizumab) franchise for preventing respiratory syncytial virus (RSV) infection in at-risk infants. Read More
Johnson & Johnson's anti-interleukin 23 candidate, guselkumab, has outperformed Abbvie Inc.'s Humira (adalimumab) in a second pivotal plaque psoriasis trial, firming up the foundation for potential U.S. and European regulatory approvals late this year. Read More
Privately held Neurovance Inc. struck a potential $250 million acquisition deal with Japanese pharma giant Otsuka Pharmaceutical Co. Ltd. on the basis of a single asset in attention-deficit hyperactivity disorder (ADHD). Read More
Even in fresh, high-quality DNA samples, the act of sequencing itself induced DNA damage at a frequency comparable to that of rare mutations occurring, potentially confounding the identification of rare variants. Read More
In a second-quarter meeting with the FDA, Scynexis Inc. will be talking about three mild to moderate thrombotic events in healthy phase I volunteers, and CEO Marco Taglietti told BioWorld Today that the company was already putting together a data package when informed by regulators that no further trials will be allowed with the intravenous (I.V.) form of the antifungal SCY-078 until questions are resolved. Read More
