Devices Market in the First Six Months of 2015: Legal Highlights
07 October 2015
Generally, 2014 was quite a challenging year for the Russian economy. Growing tension between Russia and Western countries and the “sanctions war” undermined Russia’s economic development and had a serious impact on the Russian Government’s domestic policy.
Biotech 're-tweets' in wake of pledge to rein in drug prices
07 October 2015
The last couple of months have seen the capital markets take a beating and biotech has not been immune from a 10 percent market correction and ongoing unresolved macro-economic issues that have kept Wall Street wary and on edge.
Parasitic Disease Drug Researchers Awarded Nobel Prize
06 October 2015
The 2015 Nobel Prize in Physiology or Medicine has been awarded three researchers for the development of therapies “that have revolutionized the treatment of some of the most devastating parasitic diseases,” the Nobel organization reports in a press announcement.
EyewireTV — Raindrop Near Vision Inlay PMA; MillennialEYE Live
06 October 2015
In this week's EyewireTV, ReVision Optics submits to the FDA the fourth and final module of the company’s premarket approval application for the Raindrop near vision inlay; and Ocular Therapeutix submits a new drug application to the FDA for Dextenza (dexamethasone 0.4 mg) for the treatment of ocular pain following ophthalmic surgery. Also, future and current leaders in ophthalmology discuss the hottest topics from annual MillennialEYE Live meeting in Hollywood.
06 October 2015
ReVision Optics announced the submission to the FDA of the fourth and final module of the company’s premarket approval (PMA) application for the Raindrop near vision inlay, according to a company news release. The Raindrop is a microscopic hydrogel inlay designed to correct presbyopia, thus reducing or even eliminating the need for reading glasses. The fourth module includes clinical data from more than 300 subjects who have been followed for at least 24 months post-procedure.
Clinical trial data transparency is the right thing to do
06 October 2015
At times, there can be a huge gulf between principle and practice. For example, eating healthy foods and getting lots of exercise are clearly beneficial, but they require commitment and hard work and are not sustained by many people.
Small-molecule remote control allows communication with cell therapies
06 October 2015
Researchers have developed a small-molecule "on" switch for chimeric antigen receptor (CAR) T cells that allowed them, in preclinical models, to control the cells' activity after transplantation.
Europe grants its first CE mark for leadless pacemaker to treat left ventricle
06 October 2015
EBR Systems' WiSE leadless pacemaker just earned a CE mark, becoming the first device in the class approved for improving left ventricular function. Medtronic and St. Jude Medical also offer leadless pacemakers, but they are implanted in the heart's right ventricle.
Pricing maelstrom threatens to suck in another drugmaker
05 October 2015
Hear that sucking sound? It's getting louder as the maelstrom Turing Pharmaceuticals LLC recently churned up over drug prices threatens to engulf another biopharma company.
The contentious gene editing field gets a tech upgrade. What now?
02 October 2015
Back when the patent war was brewing over CRISPR/Cas9, the Broad Institute's Feng Zhang made it clear that he believed the big innovations in gene editing still lay ahead. And in the last few days he set out to prove he was right, pointing to an alternative to Cas9 that could wind up serving as a much better tool to use to perform surgery on a gene.
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NovaMedica team wishes you a Merry Christmas and a Happy New Year!
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Russia and the UAE can simplify the drug registration process
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Orphan drug market to reach $270B by 2028 : Evaluate
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