Shares in Clearside Biomedical (NSDQ:CLSD) rose today after the biopharmaceutical company met expectations on Wall Street with its 3rd quarter results. The Alpharetta, Ga.-based company posted losses of -$5.6 million, or -28¢ per share, on sales of $5,000 for the 3 months ended Sept. 30. This is the 1st quarter that Clearside has reported revenue. Adjusted to exclude […]
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Ocular Therapeutix plans FDA re-submission for Dextenza by end of year, earnings
Shares in Ocular Therapeutix (NSDQ:OCUL) surged this morning after the biopharmaceutical company met expectations on Wall Street with its 3rd-quarter results and announced it will re-submit its new drug application to the FDA for Dextenza, its post-surgical ocular pain reliever, by the end of the year. In July, the FDA denied approval for Ocular’s hydrogel plug designed […]
FDA warns Valeant on SPAG-2 nebulizer, OraPharma OnSet mixing pen
The FDA this month warned Valeant Pharmaceuticals (NYSE:VRX) on violations found during inspections of its Rochester, N.Y., plant last summer. The federal safety watchdog, in a Nov. 3 warning letter posted online today, wrote that inspections from Aug. 23 through Sept. 1 turned up problems with its small-particle aerosol generator, the SPAG-2 device, and a high-precision compound and dispensing […]
Trump’s win boosts drug stocks
Pharmaceutical stocks surged today after Donald Trump won the U.S. presidential election, as investors concluded the threat of action on drug pricing had lessened. California’s Proposition 61, which would have prevented the state of California from purchasing drugs from a manufacturer for a price higher than that paid by the U.S. Veterans Affairs Dept., failed to […]
Gold nanoparticles target chromosomes in cancer cells
Researchers tagged gold nanoparticles with a small dose of radiation to trace the particles as they deliver a drug into the heart of a cancer cell, according to work presented at the 2016 National Cancer Research Institute conference. A team of researchers from the Oxford Institute for Radiation Oncology worked to deliver drugs to the “control […]
pSivida misses Q1 estimates, profits slide 47%
Shares in pSivida (NSDQ:PSDV) fell 6% today after the company missed expectations on Wall Street with its fiscal 1st-quarter results*. The Watertown, Mass.-based company posted losses of -$7.2 million, or -21¢ per share, on sales of $277,000 for the 3 months ended Sept. 30, for a bottom-line loss of -47% on a -41% sales decline, compared […]
Clearside Biomedical names McElheny as biz dev veep | Personnel Moves, Nov. 8, 2016
Clearside Biomedical (NSDQ:CLSD) today named Rick McElheny as its VP of business development. The Alpharetta, Ga.-based company is developing a microinjector loaded with CLS-TA (triamcinolone acetonide) to treat macular edema. The device is designed to inject the compound in the a 30-µm gap between the choroid and the sclera, called the suprachoroidal space. A pivotal Phase III […]
Hologic inks collab deal with Seegene
Seegene (KSDQ:096530) said today that it inked a collaboration deal with Hologic (NSDQ:HOLX) to develop high-multiplex, real-time PCR reagents for the developing Hologic Panther Fusion system. According to the agreement, Seegene will develop and manufacture multiplex assays for Hologic’s next-gen molecular diagnostics platform; Hologic will receive worldwide commercialization rights to the assays. Financial terms of the deal were […]
Senate panel adds to call for hearings over Mylan’s EpiPen pricing
The U.S. Senate Judiciary Committee yesterday called on the Federal Trade Commission to investigate whether Mylan (NSDQ:MYL) broke the law after reports claimed the EpiPen maker prevented schools from buying competing allergy treatments. In a letter penned to the FTC, committee chairman Sen. Charles Grassley (R-Iowa) and ranking member Sen. Patrick Leahy (D-Vt.) wrote, “increasing patient access […]
Stanford uses CRISPR to correct sickle cell, human trials planned
Researchers from the Stanford University School of Medicine have reportedly used CRISPR, a gene-editing tool, to repair the gene that causes sickle cell disease. The team is planning the 1st human clinical trial using this technique to correct cells with sickle cell disease, according to Reuters. “What we’ve finally shown is that we can do it. It’s […]
