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.
02 October 2015
The clinical data presented show the corneal inlay significantly improved near and intermediate uncorrected visual acuities across a 2.0 D range of preoperative refractive range (-0.5 D to +1.50 D) and age-related reading ADD powers between +1.50 D to +2.50 D. Near task performance was also significantly improved in good and dim light compared to preoperative levels. In the treated eye, the mean postoperative visual acuities were: 20/25 (near), 20/25 (intermediate), and 20/32 (distance). The clinical outcomes are explained by the center-near power profile of the cornea induced by the shape-changing inlay providing zones within the pupil for good near, intermediate, and distance image quality. And this thesis is confirmed by optical ray-trace predictions of visual acuity over this preoperative refractive range at distance, intermediate and near.
29 September 2015
Syndax Pharmaceuticals, Inc. and Merck, known as MSD outside the United States and Canada, today announced the dosing of the first patients in the Phase 1b/2 clinical trial of Syndax’s entinostat in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with non-small cell lung cancer (NSCLC) or melanoma.
15 September 2015
The Raindrop Near Vision Inlay (ReVision Optics) to treat presbyopia provided good near visual acuity without glasses in a study conducted and presented by Jeffrey Whitman, MD. The inlay, which is still an investigational device in the U.S., is inserted under a LASIK flap. It is a microscopic hydrogel inlay that creates a central steepening of the cornea to give a greater depth of focus, said Dr. Whitman, Key-Whitman Eye Center, Dallas.
11 September 2015
A blood test that was scarcely heard of two years ago is quickly emerging as an alternative to the often painful practice of using needles or surgery to sample a patient’s tissues for signs of cancer. Scientists from San Diego to Boston said the new “liquid biopsies” can easily detect potentially harmful tumor cells and mutated DNA traveling through the blood stream.
03 September 2015
Tragara Pharmaceuticals, Inc., Corporation just had published form D about $13.06 million equity financing. This is a new filing. Tragara Pharmaceuticals was able to fundraise $13.06 million. That is 100.00% of the financing round. The total fundraising amount was $13.06 million. The financing document was filed on 2015-09-01.
28 August 2015
Genentech has agreed to lend its closely-watched checkpoint inhibitor atezolizumab to Syndax for a combo study with the Waltham, MA-based biotech's lead drug entinostat for triple-negative breast cancer, just three days after Syndax landed an $80 million crossover round.
25 August 2015
Two months after signing up AstraZeneca ($AZN) R&D leader Briggs Morrison as its new CEO, Waltham, MA-based Syndax has raised $80 million from a syndicate that includes a group of high-profile crossover investors.
24 August 2015
If Syndax Pharmaceuticals’ latest financing is any indication, the Waltham, MA-based firm looks to have another shot at an initial public offering in mind.
07 August 2015
PharmaVOICE has named Dena Marinucci, Ph.D. CSO of Epic Sciences, to the magazine's 2015 list of 100 outstanding professionals in the life-sciences industry. Dena was chosen as part of the group of visionary entrepreneurs who recognized an opportunity to fill an industry need and are successfully leading their companies to new heights.
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