Clearside Biomedical Announces SAPPHIRE Phase 3 Study of Combination Therapy in Retinal Vein Occlusion Did Not Meet Its Primary Endpoint
Tuesday, November 06, 2018 10:44 AM

ALPHARETTA, Ga., Nov. 05, 2018 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, today announced that the primary endpoint was not achieved in its Phase 3 clinical trial (“SAPPHIRE”) investigating the superiority of XIPERE (formerly “suprachoroidal CLS-TA”) used together with the intravitreal anti-VEGF agent EYLEA® (aflibercept) (“intravitreal Eylea”), compared to intravitreal Eylea monotherapy, for the treatment of retinal vein occlusion (‘RVO”).  The primary endpoint of this trial was the proportion of patients in the combination treatment arm, compared to the intravitreal Eylea-alone control arm, with improvements in best corrected visual acuity (“BCVA”) from baseline of at least 15 letters on the Early Treatment Diabetic Retinopathy Study (“ETDRS”) scale at eight weeks after initial treatment.

“In the SAPPHIRE trial, approximately 50% of patients in both arms showed at least a 15 letter improvement in vision; unfortunately, there was no additional benefit for patients receiving XIPERE together with intravitreal Eylea,” said Daniel White, Chief Executive Officer and President of Clearside.  “In light of these 8-week topline data, we plan to discontinue clinical development of combination therapy for RVO, which includes SAPPHIRE and its companion Phase 3  clinical trial, TOPAZ.”

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Oncology Analytics Moves Corporate Headquarters to Atlanta
Tuesday, November 06, 2018 10:44 AM

ATLANTA, October 31, 2018 – Oncology Analytics, a leading technology-enabled service company which provides health plans, providers and patients with an evidence-based, analytics focused approach to utilization management that is purpose-built for oncology, announced today it is expanding its operation by moving its corporate headquarters to Atlanta, Georgia.

“Atlanta is a mecca for organizations focused on cutting edge technology and breakthrough research and innovation in cancer treatments,” said Rick Dean, CEO of Oncology Analytics. “Driving the nexus of technology and patient care is fundamental to our company’s mission. We want to be part of a dynamic, forward thinking business community that shares this vision.”

Oncology Analytics provides the critical missing link for health plans in being able to manage the total cost of cancer care – which is access to current, evidence-based, disease-specific analytics on all cancer types and treatment options, backed by board-certified oncology physicians and pharmacists, to provide their members with the ability to achieve the best possible outcomes.

Founded in Plantation, FL by Dr. Marc Fishman, a hematologist, oncologist and patient advocate, Oncology Analytics will continue to retain an active presence there. The company’s new corporate headquarters will be located at 7000 Central Parkway in the vibrant Perimeter District of Atlanta, home to over 5,000 companies.

“Having our corporate headquarters in Atlanta provides us access to some of the finest clinical, technical and analytics talent in the country,” said Shay Hurst, SVP of Human Resources, Oncology Analytics. “As we look to significantly expand our team in roles focused on data science, software engineering, clinical oncology, product management and client services, we are confident Atlanta offers the resources we need for our next stage of growth.”

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Georgia Tech names new director for Advanced Technology Development Center
Tuesday, November 06, 2018 10:05 AM

Georgia Tech said Monday it's named John Avery as its next director of its Advanced Technology Development Center (ATDC) business incubator.

The announcement follows a four-month national search for a new leader at ATDC following the departure of Jen Bonnett, who left in June 2018 to become the Savannah Economic Development Authority’s vice president of innovation and entrepreneurship.

Most recently, Avery -- a Georgia Tech graduate -- was engineering group manager of Panasonic Automotive Systems’ Panasonic Innovation Center at the Georgia Tech campus.

As director of the ATDC, Avery will lead a team of 26 full- and part-time staff and advisors who run ATDC’s various initiatives. Read the complete announcement here.

In 2017, ATDC worked with more than 1,838 entrepreneurs across the state of Georgia. Its portfolio companies and program graduates received more than $823 million in capital investments, reported more than $148 million in revenue, and supported 2,260 jobs.

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Shire Files Submission for U.S. FDA Approval to Manufacture FLEXBUMIN® at New Plasma Manufacturing Facility near Covington, Georgia
Thursday, November 01, 2018 11:09 AM

Dublin, Ireland – October 25, 2018 – Shire plc (Shire) (LSE: SHP, NASDAQ: SHPG), the leading global biotechnology company focused on rare diseases, today announced that it has filed its second submission to the United States Food and Drug Administration (FDA) for its new plasma manufacturing facility near Covington, Georgia.

This second submission is for the manufacturing of FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solution, a treatment primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions. The Georgia facility received its first FDA approval, to manufacture GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% Solution.

“We are very pleased to file this second submission for our state-of-the-art manufacturing facility in Georgia, after the facility received FDA approval earlier this year,” said Matt Walker, Head of Technical Operations for Shire. “Expanding our capacity for manufacturing FLEXBUMIN will allow us to better meet the increasing global demand for plasma protein therapies and further supports our growing immunoglobulin and bio-therapeutics portfolio by enabling us to deliver these important treatments to our patients.”

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GeoVax Announces Further Positive Results of its HIV Preventive Vaccine Program at International HIV Research Conference
Wednesday, October 24, 2018 10:43 AM

Booster Vaccination After ~7 Years Resulted in 600-fold Increase in Antibody Response

Atlanta, GA - (NewMediaWire) - October 24, 2018 - GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, today announced the presentation of positive results from HVTN 114, a phase 1 trial testing a late protein boost of participants from a phase 2a trial of GeoVax’s GOVX-B11 preventive HIV vaccine candidate. The presentation was made by the Protocol Chair, Paul A. Goepfert, M.D., University of Alabama, during the HIV Research for Prevention (HIVR4P) conference in Madrid, Spain. HVTN 114 was conducted by the HIV Vaccine Trials Network (HVTN) through the support of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). 

GOVX-B11 consists of two experimental vaccine components – a recombinant DNA component and a recombinant live MVA (modified vaccinia Ankara) virus component. Both components produce non-infectious virus-like-particles (VLPs) in the cells of the vaccinated, HIV-negative, person.

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