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Menlo Park, Calif.-based startup Tusker Medical Inc. has received U.S. FDA approval to market its breakthrough-designated system for inserting tympanostomy tubes into the eardrum to treat recurrent ear infections. The Tubes Under Local Anesthesia (Tula) system is the first delivery system for tympanostomy tubes, commonly known as ear tubes, that can be performed in young children under local anesthesia in a doctor’s office. The Tula system consists of the ionic anesthetic Tymbion, Tusker Medical tympanostomy tubes and several devices for inserting the anesthetic and tubes into the ear drum. A low-level electrical charge delivers the anesthesia to the eardrum prior to tube placement, allowing for quick and needle-free numbing of the tympanic membrane.
On its PDUFA date Thursday, the FDA cleared Xcopri (cenobamate) tablets from South Korea’s SK Biopharmaceuticals Co. Ltd. to treat partial-onset seizures in adults. The drug’s mechanism of action is not fully understood, but it's believed to work through two separate mechanisms: enhancing inhibitory currents through positive modulation of GABA-A receptors and decreasing excitatory currents by inhibiting the persistent sodium current.
Shares of San Diego-based Adamis Pharmaceuticals Corp. (NASDAQ:ADMP) fell 51% to close Monday at 62 cents after the FDA issued a complete response letter regarding its high-dose naloxone injection candidate, Zimhi, for the treatment of opioid overdose. The agency raised questions about chemistry, manufacturing and controls (CMC), but not the candidate's safety or efficacy, the company said.
The FDA has posted the names of the companies that will take part in the ethylene oxide (EtO) challenge in response to the recent state action against EtO device sterilization sites, but the agency also has opened a pilot program for a streamlined notification process for changes to sterilization that should be faster and leaner than the usual PMA supplement.
On its PDUFA date Thursday, the FDA cleared Xcopri (cenobamate) tablets from South Korea’s SK Biopharmaceuticals Co. Ltd. to treat partial-onset seizures in adults. The drug’s mechanism of action is not fully understood, but it's believed to work through two separate mechanisms: enhancing inhibitory currents through positive modulation of GABA-A receptors and decreasing excitatory currents by inhibiting the persistent sodium current.
Shares of Eyegate Pharmaceuticals Inc. (NASDAQ:EYEG) rose 54.8% to $7.09 Friday on news that its ocular bandage gel (OBG) proved superior to standard of care in healing corneal wounds following photorefractive keratectomy (PRK) surgery. The pivotal top-line data will allow the Waltham, Mass.-based company to submit a de novo application to the FDA for commercialization in the first half of 2020, said CEO Stephen From. If approved, the OBG eye drop would be the first product indicated to repair corneal epithelial defects, as well as the first prescription hyaluronic acid (HA) eye drop in the U.S., creating new competition for widely used bandage contact lenses (BCL).
Recro Pharma Inc. CEO Geraldine Henwood said the firm, in response to its appeal to the FDA on behalf of I.V. meloxicam for moderate to severe postoperative pain, got a “very lengthy letter” agreeing that safety and efficacy were sufficient for approval but “there was a need to negotiate labeling.”
LONDON – It’s no secret that American citizens pay the most for drugs, but the extent of the disparity is laid bare in a new index of the prices of 13 medicines...
The U.S. FDA has cleared Cochlear Ltd.’s newest cochlear implant, the Osia 2 system, an active implantable bone conduction hearing system. Unlike Cochlear’s...
Commissioner of the FDA for five years starting in 1984, Frank Young relished his position “at the vortex of controversy” as he sought to deal with the AIDS...
After being in the doldrums for the majority of the year, public biopharmaceutical companies, it appears, have turned the corner and are now on a major upswing.
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