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 […]
Drug-Device Combinations
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 […]
UPDATE: BTG’s U.S. Biocompatibles business to pay $36m settlement, plead guilty to misbranding
Updated to include BTG’s guilty plea entered Nov 7. BTG (LON:BTG) said today that it agreed to pay the U.S. Justice Dept. $36 million (£28.4 million) to settle a probe into the marketing of the LC Bead embolization microspheres made by its Biocompatibles subsidiary. The company plead guilty on Monday, November 7, to charges of improperly marketing […]
Flamel Technologies tops Q3 revenue, EPS estimate
Shares in Flamel Technologies (NSDQ:FLML) rose today after the pharmaceutical company met expectations on Wall Street with its 3rd quarter results. The Venissieux, France-based company posted a loss of -$22.3 million on sales of $32.1 million for the 3 months ended Sept. 30, for bottom-line growth of 20% despite a sales loss of 32% compared with the […]
PAVmed partners with Boston institutions for antibiotic-eluting ear device
PAVmed Inc. (NSDQ:PAVMU) said today that it inked an exclusive licensing agreement with academic institutions to develop and commercialize antibiotic-eluting resorbable ear tubes based on an aqueous silk technology designed by the institutions. The licensing deal includes agreements with Tufts University, Massachusetts Eye & Ear Infirmary and Massachusetts General Hospital, who developed the aqueous silk technology. As […]
Propeller wins FDA nod for connected GSK Ellipta inhaler
Propeller Health said today that it won 510(k) clearance from the FDA to market its Propeller platform with GlaxoSmithKline‘s (NYSE:GSK) Ellipta inhaler. A sensor for the dry powder inhaler was built as a part of a 1 year-long development and R&D collaboration between Propeller and GSK. This marks the 8th clearance for Propeller’s connected inhaler platform. […]
CMS acting chief Slavitt slams drug pricing
Centers for Medicare & Medicaid Services acting chief Andy Slavitt admonished pharma companies like Mylan (NSDQ:MYL) over unsustainable price increases before the Biopharma Congress in Washington D.C. last week. Mylan came under fire this year after reports showed that the Canonsburg, Penn.-based company raised the price of its emergency allergy epinephrine injector by 500% since it acquired the product in 2007 […]
Lab models drug-eluting polymer beads in blood flow
Researchers from the University of Huddersfield developed a method to predict how drug-eluting polymer beads can affect the body if they are modified. The UK team of researchers published their work in the European Journal of Pharmaceutical Sciences. Polymer beads are frequently used in cases of liver cancer, where they’re injected into a patient’s arteries to block […]
Antibacterial coated suture wins WHO recommendation
Ethicon said today that its triclosan-coated suture was included in the new “Global Guidelines for the Prevention of Surgical Site Infections (SSI)” by the World Health Organization. The guidelines are the 1st global guidelines for preventing surgical site infections. “The panel suggests the use of triclosan-coated sutures for the purpose of reducing the risk of […]
Mylan, Teva crash on report that Justice Dept. could file charges in generic pricing probes
The U.S. Justice Dept. could reportedly file charges in its generic-drug pricing probe into companies including Mylan Pharmaceuticals (NSDQ:MYL) and Teva Pharmaceuticals (NYSE:TEVA) by the end of year. The department is examining whether the generic drug makers colluded on drug pricing, Bloomberg reported yesterday. The news source said that Mylan and Teva have disclosed subpoenas and are cooperating […]
