The FDA this week announced that it’s mandating labeling changes to cut the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in kids under 18 years of age. The agency wrote in a statement that the risks of these drugs outweigh their potential benefits for children. The medications will also receive […]
Pharmaceuticals
Endo Pharmaceuticals hit with subpoena over opioid products
Endo Pharmaceuticals (NSDQ:ENDP) was hit by a grand jury subpoena yesterday from the U.S. Attorney’s Office for the Southern District of Florida over its oxymorphone products. The subpoena requests an array of documents, including those derived from past or pending lawsuits, product safety and efficacy, overdoses, diversion, theft, abuse and misuse, withdrawal and addictiveness. The attorney’s […]
Medtronic touts therapy delivered via SynchroMed pump in patients with post-stroke spasticity
Medtronic (NYSE:MDT) touted data today showing that intrathecal baclofen therapy delivered via the company’s SychroMed II infusion pump performed better than the conventional treatment for patients with severe post-stroke spasticity. The medtech titan’s SynchroMed II pump is the only device approved in the U.S. for ITB therapy. The Sisters study pitted Medtronic’s ITB therapy against oral […]
Cordis, Medinol tout first commercial implants of Elunir drug-eluting stent in U.S.
Cordis and Medinol announced today that the first commercial uses of the Elunir drug-eluting stent in the U.S. were performed at New York-Presbyterian Hospital/Columbia University Medical Center and the Piedmont Heart Institute in Atlanta. The Elunir stent, developed by Medinol and distributed by Cordis, features a metallic spring tip and the narrowest strut width of […]
Braeburn raises $110m for opioid use disorder depot injection
Braeburn Pharmaceuticals has raised $110 million in a mezzanine round of financing led by Wellington Capital. Other investors included Avista Capital Partners, RA Capital Management, Deerfield Management and Apple Tree Partners. The Princeton, N.J.-based company said it plans to use the new funds to support the FDA approval process and commercialization of CAM2038, a weekly […]
Svelte Medical launches pivotal trial for drug-eluting stent-on-a-wire
The first patient has been enrolled in Svelte Medical System‘s Optimize pivotal trial, which is designed to evaluate the safety and efficacy of Svelte’s drug-eluting stent integrated delivery system and rapid exchange platforms. The 2,000-person trial comes in the wake of a first-in-man trial for Svelte’s product and a study comparing the system with Medtronic‘s […]
Eyenovia sets range for IPO
N.Y.-based startup Eyenovia updated its regulatory filings to reveal that it plans to offer 2.73 million shares priced between $10 – $12 apiece in its initial public offering. The 7-person company, which is developing a device to deliver small doses of drugs to the eye, is applying to list on the Nasdaq exchange under the […]
Glaukos touts Ph2 glaucoma trial for drug-eluting intraocular implant
Glaukos (NYSE:GKOS) touted data today from a Phase II trial of its travoprost intraocular implant in a 12-month cohort of glaucoma patients. The company’s iDose device is placed during a micro-invasive procedure and filled with a special formulation of travoprost – a drug used to reduce intraocular pressure. The implant continuously delivers therapeutic levels of travoprost […]
At confirmation hearing for Trump’s HHS nominee, drug pricing takes center-stage
Alex Azar, the president’s nominee to head the Dept. of Health & Human Services, has nearly a decade of experience in the pharmaceutical industry – and that experience is either predictive of his inability to act on lowering drug prices or will serve him well as HHS chief, depending on who you ask. At Azar’s […]
FDA approves clinician app for Medtronic’s SynchroMed II drug pump
The FDA has approved a new clinician application for Medtronic‘s (NYSE:MDT) SynchroMed II intrathecal drug pump. The newly-approved programmer was designed to give doctors visual tools and improved workflows to simplify therapy management. The medtech titan’s implantable pump, which has been problematic in the past, delivers drugs directly to the fluid around the spinal cord. […]