Glaukos completes enrollment in Phase 3 trials for iDose TR drug-eluting implant

Glaukos (NYSE:GKOS) announced today that it completed enrollment for a Phase 3 clinical program for its iDose TR sustained-release travoprost implant.

San Clemente, Calif.-based Glaukos’ iDose TR implant contains a novel formulation of travoprost, a prostaglandin analog used to reduce intraocular pressure (IOP) through a design that continuously releases therapeutic levels of the medication for at least one year. Once all travoprost is released, the implant can be removed and replaced with a new iDose TR as an alternative to daily eye drop treatment.

Get the full story at our sister site, Drug Delivery Business News.

Read more
  • 0

DePuy Synthes launches next-gen variable angle clavicle plate system

[Image from DePuy Synthes]Johnson & Johnson (NYSE:JNJ) unit DePuy Synthes announced that it launched the 2.7 mm variable angle locking compression plate (VA LCP) clavicle plate system.

West Chester, Pa.-based DePuy Synthes designed the VA LCP clavicle plate system for the treatment of lateral, shaft and medial fractures for small, medium and large clavicles.

Get the full story at our sister site, Medical Design & Outsourcing.

Read more
  • 0

NeuroMetrix reports mixed results in fibromyalgia trial

NeuroMetrix (NSDQ:NURO) announced a mixed bag of top-line results from its trial of Quell in patients with fibromyalgia.

Woburn, Mass.-based NeuroMetrix’s double-blind, randomized, sham-controlled trial evaluated the treatment of fibromyalgia with Quell, an over-the-counter novel transcutaneous electrical nerve stimulator (TENS) indicated for symptomatic relief and management of chronic lower extremity pain.

Quell, a wearable device that can be used during the day while active and at night while sleeping, offers personalized and manageable therapy through its mobile app and provides health tracking metrics relevant to chronic pain sufferers, according to a news release.

The trial, conducted at the Center for Pain Management at Brigham & Women’s Hospital in Boston, enrolled 119 subjects with fibromyalgia, randomizing the subjects to a standard (active) or modified (sham) Quell device for three months of at-home use. Subjects registered an …

Read more
  • 0

Amazon wins EUA to sell its COVID-19 test directly to consumers

Amazon subsidiary STS Lab Holdco received FDA emergency use authorization (EUA) for the direct-to-consumer sale of its COVID-19 test.

The FDA authorized the test with indications as a direct-to-consumer product for testing individual anterior nasal swab specimens self-collected at home with the Amazon COVID-19 test collection kit DTC by any individual 18 years or older, according to an FDA letter.

STS Lab Holdco previously won EUA in March for the real-time PCR test without the direct-to-consumer sale option. The current indication includes those without symptoms or other reasons to suspect COVID-19 infection and is limited to authorized laboratories.

Authorization extends to pooled samples containing up to five individual anterior nasal swab specimens per pool that are self-collected in individual vials containing transport medium, the letter reads.

Test results from specimens collected with the Amazon COVID-19 test collection kit DTC can be deli…

Read more
  • 0

U.S. to buy nearly 2 million courses of Merck’s COVID-19 antiviral treatment

Merck (NYSE:MRK) announced today that it entered into an agreement to supply the U.S. government with its molnupiravir (MK-4482) for treating COVID-19.

Molnupiravir, developed through a collaboration between Merck and Ridgeback Biotherapeutics, is currently under evaluation in a Phase 3 clinical trial for the treatment of non-hospitalized patients with laboratory-confirmed COVID-19 infection and at least one risk factor associated with poor disease outcomes.

Get the full story at our sister site, Pharmaceutical Processing World.

Read more
  • 0

How to Avoid the Top 8 Micro Design Mistakes

Nothing is more frustrating for micro medical part designers than to spend countless hours on a new drawing, only to get to the manufacturing phase and find out they need to make significant revisions or compromises.

Download this white paper to learn how to improve the manufacturability of your next micro design.

if(!gform){document.addEventListener("gform_main_scripts_loaded",function(){gform.scriptsLoaded=!0}),window.addEventListener("DOMContentLoaded",function(){gform.domLoaded=!0});var gform={domLoaded:!1,scriptsLoaded:!1,initializeOnLoaded:function(o){gform.domLoaded&&gform.scriptsLoaded?o():!gform.domLoaded&&gform.scriptsLoaded?window.addEventListener("DOMContentLoaded",o):document.addEventListener("gform_main_scripts_loaded",o)},hooks:{action:{},filter:{}},addAction:function(o,n,r,t){gform.addHook("action",o,n,r,t)},addFilter:function(o,n,r,t){gform.addHook("filter",o,n,r,t)},doAction:function(o){gform.doHook("action",o,arguments)},applyFilters:fu…
Read more
  • 0

Inogen appoints chief medical officer

Inogen (NSDQ:INGN) this week announced that it has appointed Stanislav Glezer as executive VP and chief medical officer, effective June 21.

Glezer joins the Goleta, Calif.-based company after a stint as worldwide VP of medical care for diabetes care at BD. Prior to BD, he served as chief medical officer at Adocia and has held numerous leadership roles within Novo Nordisk and Sanofi.

“On behalf of the board of directors, I would like to congratulate Stan on this appointment as I am confident that he will be a tremendous asset to Inogen and a great addition to our executive team. I believe that expanding our clinical expertise and evidence dossier in respiratory therapy will serve us well in our endeavors to drive our market development efforts to eventually increase the penetration of portable oxygen concentrators (POCs) in support of our growth strategy as well as help guide our innovation agenda,” CEO Nabil Shabshab said in a news release. “I belie…

Read more
  • 0

DJO acquires Mathys AG Bettlach

Colfax Corp.’s DJO this week announced that it entered into a definitive agreement to acquire Mathys AG Bettlach for an undisclosed amount.

Mathys makes and distributes products for artificial joint replacement, synthetic bone graft solutions and sports medicine. The acquisition is expected to strengthen DJO’s patient-focused innovation pipeline and broaden its reconstructive portfolio.

Get the full story on our sister site, Medical Design & Outsourcing.

Read more
  • 0

Meet the drugs and devices giving hope to millions of migraine patients

Photo by Liza Summer from Pexels

But up until recently, neurologists had relatively few tools at their disposal to help migraine patients. The treatment landscape has evolved considerably in recent years, explains Alexander Feoktistov, a neurologist at the Synergy Integrative Headache Center in Chicago. “I’ve been in this field of headache medicine for probably over 20 years now, and I’ve never been as excited to work in this field as in the past few years,” he said.

The most recent article in a two-part interview with Dr. Feoktistov discusses both drug and device treatments for migraine headaches, which affect roughly one billion people globally.

Dr. Alexander Feoktistov

How has the migraine treatment landscape evolved in recent years?

Feoktistov: It has been unprecedented. It’s like a small revolution in the headache medicine field in the past three years.

So the first CGRP monoclonal antibody, which was erenumab-aooe, came out in May of 2018. A…

Read more
  • 0

Pfizer expands COVID-19 vaccine trial involving children under 12

Pfizer (NYSE:PFE) and its German partner BioNTech (NASDAQ: BNTX) will proceed with a COVID-19 vaccine trial involving as many as 4,500 children. The trial will significantly reduce the 30-mg dose that adults and adolescents receive. Investigators will administer a 10-µg dose to children aged 5 to 11 and give those aged six months to five years old a 3-µg dose.

The company anticipates data from 5- to 11-year-olds in September and plans on filing for emergency use authorization shortly after that.

The company anticipates that data for the 6-month to 2-year-old cohort will be available in October or November.

Get the full story from our sister site, Drug Discovery & Development.

Read more
  • 0

Biden administration wants to boost funding for new pharma manufacturing processes

President Joe Biden [Image courtesy of the White House]The Biden administration today released findings from 100-day supply chain assessments, determining the need to boost pharmaceutical manufacturing.

According to a fact sheet, the administration plans to take immediate action to “address vulnerabilities and strengthen resilience” with its effort to take on near-term supply chain disruptions for four products: semiconductor manufacturing and advanced packaging; large capacity batteries, like those for electric vehicles; critical minerals and materials; and pharmaceuticals and active pharmaceutical ingredients (APIs).

Get the full story at our sister site, Pharmaceutical Processing World.

Read more
  • 0

Private equity firms making majority investment in Medline

Medline Industries will stay a privately-held, family-run medtech giant after a majority investment from private equity firms.

Blackstone, Carlyle and Hellman & Friedman are making the investment in Medline, which media reports peg at $34 billion.

Get the full story on our sister site Medical Design & Outsourcing. 

Read more
  • 0