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• ReVision Optics Files Final Module of FDA Premarket Approval Application for Raindrop Near Vision Inlay

  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.

• Range of refractive independence and mechanism of action of a corneal shape–changing hydrogel inlay: Results and theory

  02 October 2015 Roger F. Steinert, MD, Jim Schwiegerling, PhD, Alan Lang, PhD, Adam Roy, MS, Keith Holliday, PhD, Enrique Barragán Garza, MD, Arturo S. Chayet, MD / Journal of Cataract Refractive Surgery

  

  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. 

• Syndax and Merck Announce First Patients Dosed in Phase 1b/2 Clinical Trial of Entinostat and KEYTRUDA

  29 September 2015 The FINANCIAL

  

  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.

• Tackling presbyopia with an inlay

  15 September 2015 Vanessa Caceres, Jeffrey Whitman MD / Ophthalmology Times

  

  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.

• New blood test helps detect cancer early

  11 September 2015 Gary Robbins / The San Diego Union-Tribune

  

  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.

• Tragara Pharmaceuticals $13.06 million Financing. Thomas M Estok Filed Sep 1 SEC Form

  03 September 2015 Private Financing News

  

  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. 

• Syndax adds Genentech PD-L1 'atezo' combo pact to its growing pipeline

  28 August 2015 John Carroll / FierceBiotech

  

  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.

• Syndax banks an $80M crossover round for PhIII cancer drug

  25 August 2015 John Carroll / FierceBiotech

  

  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.

• New CEO and $80M Later, Syndax Looks Prepped for Second IPO Try

  24 August 2015 Ben Filder / Xconomy

  

  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.

• Epic's CSO Dena Marinucci Named to Pharmavoice 100

  07 August 2015 PharmaVoice.com

  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.