Shares of Portola Pharmaceuticals Inc. (NASDAQ:PTLA) climbed 46.6 percent to close at $56.06 on Friday after the company won FDA approval for its once-daily factor Xa inhibitor, Bevyxxa (betrixaban), for the prevention of venous thromboembolism (VTE) in certain adults.
Provention Bio Inc., a young company advancing two phase II-ready assets from Janssen Research & Development LLC and a vaccine platform technology from Finland's Vactech Oy, has raised its first financing, $28.4 million, in a private placement of series A preferred stock that closed April 25. Provention will use proceeds of the offering to develop the assets through proof of concept.
SAN DIEGO – Ambitious venture funds from Russia, China and India are seeking a growing stake in U.S. companies, creating new access to capital for startups. Though offering value beyond money to both investors and the recipients of their funds, international venture capitalists speaking at BIO 2017 said cultural and political frictions can still create challenges.
SAN DIEGO – Fungal infections, though equally as dangerous as bacterial and viral infections, often fail to secure the attention of high-profile superbugs like methicillin-resistant Staphylococcus aureus (MRSA) or get swept under the rug as a conversation too unseemly to contemplate. Like the late comedian and actor Rodney Dangerfield, they "get no respect," said Tom Chiller, chief of the mycotic disease branch of the Centers for Disease Control and Prevention, during a session at BIO 2017.
SAN DIEGO – Glenmark Pharmaceuticals Inc. has struck a deal to license a small-molecule cancer candidate from APC Therapeutics Inc., gaining worldwide development and commercialization rights to a compound based on antigen-presenting cell (APC) biology with potential as a monotherapy or in combination with existing therapies, it said.
A pivotal study of the rheumatoid arthritis (RA) candidate sirukumab in patients whose needs aren’t met by standard RA therapies has shown that a year of treatment with the anti-interleukin (IL)-6 antibody improved the signs and symptoms of moderate to severe RA. The results help lay further groundwork for an anticipated FDA approval and launch of the medicine later this year. Janssen-Cilag International NV and its partner, Glaxosmithkline plc, initiated the phase III program for sirukumab in August 2012. The candidate’s lineage dates back to Janssen precursor Centocor Ortho Biotech Inc. (See BioWorld Today, Aug. 24, 2012.)
Interim data from Epizyme Inc.’s ongoing phase II trial of EZH2 inhibitor tazemetostat boosted company shares (NASDAQ:EPZM) Wednesday as investors embraced news that 92 percent of patients with relapsed or refractory follicular lymphoma and EZH2-activating mutations treated with the experimental therapy saw their tumors shrink. People with the same mutation and diffuse large B-cell lymphoma (DLBCL) also benefited, though at a lower rate than seen in an earlier preview of the data. Both cancers are forms of non-Hodgkin lymphoma.
With plans to land a new drug application for its treatment-resistant depression candidate, ALKS-5461, on FDA's doorstep before year's end, Alkermes plc is launching a phase IIIb trial intended to bolster its case for approval. Called study 217, the trial will evaluate whether or not adding '5461 to standard antidepressant therapies helps improve both depressive symptoms and participants' moods, a new facet not closely measured in earlier studies. Efficacy outcomes in earlier phase III studies of the candidate have been mixed.
Teva Pharmaceutical Industries Ltd. has won FDA approval for the first generic version of Gilead Sciences Inc.'s Truvada (emtricitabine/tenofovir disoproxil fumarate) a treatment for HIV-1, in combination with other antiretroviral agents, and for pre-exposure prophylaxis.
