Inotek Pharmaceuticals (NSDQ:ITEK) said last week that its glaucoma drug failed in a Phase II trial. This marks the 2nd problem for Inotek’s drug this year, after it failed in a late-stage trial comparing it to a placebo in January. In response to the data, CEO David Southwell said in a statement that the company […]
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Ocular Therapeutix faces more manufacturing problems as FDA decision deadline looms
Shares in Ocular Therapeutix (NSDQ:OCUL) fell last week after the company revealed that it received another letter from the FDA about issues spotted by the regulatory agency during a pre-approval inspection of a manufacturing plant. This isn’t the first time that the company has dealt with manufacturing issues. In July last year, the FDA denied approval for Ocular’s hydrogel […]
FDA clears first new sickle cell treatment in 20 years
Emmaus Life Sciences said last week that the FDA approved its L-glutamine oral powder, Endari, as a therapy to lessen the complications of sickle cell disease in patients ages 5 and older. The drug’s approval was supported by data from a Phase III trial evaluating Endari compared to a placebo in 230 adults and children […]
Resolute Onyx drug-eluting stent launches in Japan
Medtronic (NYSE:MDT) said this week that it’s Resolute Onyx drug-eluting stent will launch in Japan on July 10th. The device’s predecessor, Resolute Integrity, began selling in Japan in August 2012. The drug-eluting stent has a metallically dense, radiopaque inner core within the cobalt alloy wire to boost visibility for accurate placement, according to Medtronic. The stent […]
Medtech stories we missed this week: July 7, 2017
From EnvisionTEC’s FDA approval to InVivo Therapeutics adding a new clinical site, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. EnvisionTEC wins FDA nod for 3D printing E-Denture material EnvisionTEC announced in a June 30 press release that it has received FDA approval for its E-Denture material […]
Pacira halts DepoCyt production over manufacturing issue
Pacira Pharmaceuticals (NSDQ:PCRX) said late last month that it plans to stop producing its liposomal chemotherapeutic due to “persistent technical issues specific to the DepoCyt(e) manufacturing process.” In a regulatory note filed to the SEC, the N.J.-based company said it expects a charge of $5 million thanks to the discontinuation, including $500,000 related to employee lay-offs. […]
Capillary Biomedical takes aim at ‘the Achilles heel of diabetes’
Major players in the medical device realm are in a heated race to develop the first artificial pancreas to help patients with diabetes manage the chronic condition. Just last year, Medtronic (NYSE:MDT) won FDA approval for its MiniMed 670G hybrid-closed loop system. But while companies compete for the top spot in developing what could be a […]
Researchers develop light-sensitive hydrogel for drug delivery
Researchers at the Hong Kong University of Science and Technology have developed a light-sensitive hydrogel that could be useful for drug delivery. Conventional materials for hydrogel scaffolds include synthetic polymers or natural biomolecules. This leaves the material to exist as a passive scaffold that can’t interact with the signals involved in biological processes. Instead, this […]
Endo pulls painkiller from the market following FDA request
Endo Pharmaceuticals (NSDQ:ENDP) said today that it will voluntarily pull its Opana ER painkiller from the market. The move comes just weeks after the FDA asked the company to pull the plug on its opioid, arguing that the benefits of the abuse-deterrent drug no longer outweigh the risks. To write off the remaining net book value […]
Google backs Decibel Therapeutics in big data hearing loss play
Decibel Therapeutics said today it landed an investment from GV, formerly Google Ventures. GV agreed to make an equity investment in the Boston-based company and lend its capabilities in big data sciences and analytics to Decibel’s efforts in developing therapies for hearing loss and tinnitus. “We are delighted to work with GV to amplify our […]