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Clearside tops Q3 estimates, posts license revenue

November 9, 2016 By Sarah Faulkner

Clearside Biomedical

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 […]

Filed Under: Drug-Device Combinations, Featured, MassDevice Earnings Roundup, Optical/Ophthalmic Tagged With: Clearside Biomedical

Ocular Therapeutix plans FDA re-submission for Dextenza by end of year, earnings

November 9, 2016 By Sarah Faulkner

Ocular Therapeutix

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 […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), MassDevice Earnings Roundup, Optical/Ophthalmic, Wall Street Beat Tagged With: Ocular Therapeutix

FDA warns Valeant on SPAG-2 nebulizer, OraPharma OnSet mixing pen

November 9, 2016 By Sarah Faulkner

California insurance board subpoenas Valeant

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 […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Respiratory Tagged With: Valeant Pharmaceuticals

Trump’s win boosts drug stocks

November 9, 2016 By Sarah Faulkner

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 […]

Filed Under: Featured, Pharmaceuticals, Policy, Wall Street Beat Tagged With: Mylan, Novo Nordisk, Roche

Gold nanoparticles target chromosomes in cancer cells

November 9, 2016 By Sarah Faulkner

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 […]

Filed Under: Featured, Nanoparticles, Oncology, Pharmaceuticals Tagged With: National Cancer Research Institute, Oxford Institute for Radiation Oncology

pSivida misses Q1 estimates, profits slide 47%

November 8, 2016 By Sarah Faulkner

pSivida

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 […]

Filed Under: Drug-Device Combinations, Featured, MassDevice Earnings Roundup, Optical/Ophthalmic Tagged With: pSivida Corp.

Clearside Biomedical names McElheny as biz dev veep | Personnel Moves, Nov. 8, 2016

November 8, 2016 By Sarah Faulkner

Clearside Biomedical

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 […]

Filed Under: Drug-Device Combinations, Featured, Optical/Ophthalmic, Personnel Tagged With: Clearside Biomedical, johnsonandjohnson

Hologic inks collab deal with Seegene

November 8, 2016 By Sarah Faulkner

Hologic, 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 […]

Filed Under: Diagnostics, Featured, Research & Development Tagged With: Hologic Diagnostics, Seegene

Senate panel adds to call for hearings over Mylan’s EpiPen pricing

November 8, 2016 By Sarah Faulkner

Mylan

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 […]

Filed Under: Drug-Device Combinations, Featured, Legal News, Pharmaceuticals, Wall Street Beat Tagged With: Federal Trade Commission (FTC), Mylan, U.S. Justice Dept.

Stanford uses CRISPR to correct sickle cell, human trials planned

November 8, 2016 By Sarah Faulkner

Stanford Medicine

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 […]

Filed Under: Clinical Trials, Featured, Research & Development, Stem Cells Tagged With: Broad Institute, Stanford University, University of California Berkeley

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