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Opexa Therapeutics CEO Invited To Be Part Of The Panel At New York CEO Conference

Opexa Therapeutics CEO Invited To Be Part Of The Panel At New York CEO Conference

Opexa Therapeutics, Inc. announced that Neil K. Warma, the company’s  President and Chief Executive Officer, recently served as a panelist at the New York CEO Conference, which was held from November 12 – 13, 2014 in New York. Woodlands-based Opexa is a biopharmaceutical company focused on developing personalized immunotherapies to treat major illnesses such as multiple sclerosis, neuromyelitis optic, and other autoimmune diseases. Opexa uses T-cell ...

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ZS Pharma To Present At Phase 3 HARMONIZE (ZS004) Trial Results In Patients With Hyperkalemia At AHA Annual Meeting

ZS Pharma To Present At Phase 3 HARMONIZE (ZS004) Trial Results In Patients With Hyperkalemia At AHA Annual Meeting

ZS Pharma announced that data regarding ZS-9 (sodium zirconium cyclosilicate), their investigational treatment for hyperkalemia currently being tested in the HARMONIZE (ZS004) clinical trial, will be presented at the American Heart Association Annual Scientific Meeting from November 15 – 19. Hyperkalemia is characterized by high levels of potassium; it can be a life-threatening condition, since it can lead to arrhythmia and cardiac death. The high levels of potassium ...

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International Biophysics Requests Patent Protection for its AffloVest

International Biophysics Requests Patent Protection for its AffloVest

Austin-based International Biophysics Corporation is has announced that it will ask for U.S. patent protection from the U.S. Food and Drug Administration regarding its breakthrough technology, the AffloVest. The vest is the first-of-its-kind, self-contained, and portable High Frequency Chest Wall Oscillation (HFCWO) device to be commercialized in the United States and is indicated for airway clearance, cough productivity, and lessens difficulty of breathing, ...

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FDA Grants $1.6 Million to CTRC Study on Glioblastoma Treatment

FDA Grants $1.6 Million to CTRC Study on Glioblastoma Treatment

A scientist at one of the country’s leading academic cancer centers and National Cancer Institute (NCI) Designated Cancer Center, the Cancer Therapy & Research Center (CTRC) at The University of Texas Health Science Center at San Antonio, is the recipient of a $1.6 million orphan disease research grant from the US Food & Drug Administration. This grant will fund lead researcher ...

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AveXis’ Experimental Treatment for Spinal Muscular Atrophy Granted Orphan Drug Status

AveXis’ Experimental Treatment for Spinal Muscular Atrophy Granted Orphan Drug Status

The U.S. Food and Drug Administration recently granted ChariSMA, an experimental gene therapy for the treatment of Spinal Muscular Atrophy, orphan drug status, which is given to therapeutic products aimed at treating rare diseases or conditions that affect less than 200,000 people in the United States. ChariSMA is being developed by Dallas-based AveXis, and is currently in phase 1 clinical trials at Nationwide Children’s Hospital in ...

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Invictus Files FDA Application for GelShield Device for Newborns

Invictus Files FDA Application for GelShield Device for Newborns

One of the concerns a parent has for their newborn is having to be mindful of prolonged contact pressure around the baby’s scalp while he or she has yet to develop a hardened skull, as well as having the ability to support head and neck movements. Normally, parents have to periodically turn the infant’s head to rest on different sides ...

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FDA Recalls Unique Pharmaceuticals’ Sterile Drugs Due to Insanitary Conditions

FDA Recalls Unique Pharmaceuticals’ Sterile Drugs Due to Insanitary Conditions

The U.S. Food and Drug Administration (FDA) is recommending health care professionals and consumers avoid the use of all non-expired drug products produced for sterile use by Temple, Texas producer Unique Pharmaceuticals, as well as asking individuals to voluntarily recall the products, since an inspection of the company’s facilities confirmed insanitary conditions and sterility failures. Although the FDA has not received any ...

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Insys Granted FDA Orphan Drug Designation For Cannabidiol Epilepsy Treatment

Insys Granted FDA Orphan Drug Designation For Cannabidiol Epilepsy Treatment

Insys Therapeutics, an Arizona-based company with manufacturing facilities in Austin, recently announced that the Food and Drug Administration (FDA) has granted orphan drug designation for its product, which will provide the therapy with seven years of market exclusivity, among other financial incentives. Insys is producing and commercializing Cannabidiol, a cannabinoid treatment for Dravet syndrome. According to the Dravet Syndrome Foundation, this disease, also known ...

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First Integrated Stationary and Portable Oxygen Concentrator System Activox DUO2 Cleared by the FDA

First Integrated Stationary and Portable Oxygen Concentrator System Activox DUO2 Cleared by the FDA

Austin’s Inova Labs, a manufacturer of innovative oxygen therapy solutions, received clearance from the FDA to commercialize Activox DUO2, the first fully-integrated stationary and portable oxygen concentrator system. The system, designed for patients with respiratory conditions who need to be able to carry oxygen outside of their home, will be available in the upcoming months. Activox DUO2 works like a regular home-use stationary concentrator, but it also ...

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DNAtrix Drug For Recurrent Glioblastoma Receives Fast Track FDA Status

DNAtrix Drug For Recurrent Glioblastoma Receives Fast Track FDA Status

DNAtrix, a Houston-based company focused on several cancer indications, including recurrent glioblastoma, was granted Fast Track status by the U.S. Food and Drug Administration (FDA) for DNX-2401, a replication-competent adenovirus that has been studied for more than a decade at the University of Texas MD Anderson Cancer Center. The FDA Fast Track status facilitates the development of new products that the FDA believes have potential ...

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VuCOMP Announces FDA Approval of New Version of M-Vu CAD for Breast Cancer Detection in Several Digital Platforms

VuCOMP Announces FDA Approval of New Version of M-Vu CAD for Breast Cancer Detection in Several Digital Platforms

VuCOMP, Inc., a Texas-based developer of advanced computer vision systems for breast cancer detection, announced that its M-Vu Computer-Aided Detection (CAD) for mammography version 3.1. was approved by the U.S. Food and Drug Administration (FDA). The company also plans to launch an updated version of its CAD station that will include the ability to process additional standard screening views for technicians ...

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UT Southwestern Study Provides Evidence to the FDA of an Association between Testosterone and Cardiovascular Risks

UT Southwestern Study Provides Evidence to the FDA of an Association between Testosterone and Cardiovascular Risks

Men receiving testosterone treatment should be aware of studies led by Dr. Rebecca Vigen of the University of Texas at Southwestern Medical Center, Dallas, and the Food and Drug Administration (FDA). Dr. Vigen reported that a retrospective cohort study of 8,709 men with low testosterone levels showed a 30% increased risk for myocardial infarction, stroke, or death in those patients ...

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Budesonide Rectal Foam For Ulcerative Colitis Receives NDA Acceptance From FDA

Budesonide Rectal Foam For Ulcerative Colitis Receives NDA Acceptance From FDA

Rectal foam may not sound like a standard, over-the-counter medicine, however, its use in treating IBD, Crohn’s disease, and ulcerative colitis is well documented. Recently, Salix’s own Budesonide-based rectal foam for ulcerative colitis was approved by the Food and Drug Administration in a New Drug Application (NDA), clearing the way for the product to be introduced into the patient population. According to the ...

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Temple-Based Unique Pharmaceuticals Voluntarily Registers as Outsourcing Facility with FDA

Temple-Based Unique Pharmaceuticals Voluntarily Registers as Outsourcing Facility with FDA

Temple, Texas-based Unique Pharmaceuticals recently made an announcement that it will take steps to ensure compliance with the recently enacted Drug Quality and Security Act by voluntarily registering with the FDA as a Human Drug Compounding Outsourcing Facility. The decision came in reaction to an official memo issued by the FDA recently, which encouraged hospital purchasers to require their compounding pharmacy partners that supply ...

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Plano-Based Argon Medical Gets FDA Market Approval For Option™ELITE Retrievable Vena Cava Filter

Plano-Based Argon Medical Gets FDA Market Approval For Option™ELITE Retrievable Vena Cava Filter

Argon Medical’s Option(TM)ELITE Retrievable Vena Cava Filter has just received FDA Market Approval. Already marketed in Canada and soon to be sold in Europe, OptionELITE is an improvement over standard vena cava (IVC) filters. Often implanted in patients at risk for pulmonary embolisms to prevent blood clots from reaching the pulmonary artery, IVC filters must be carefully and accurately placed in ...

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FDA Rejects Sanofi’s New Multiple Sclerosis Drug Lemtrada (Alemtuzumab)

FDA Rejects Sanofi’s New Multiple Sclerosis Drug Lemtrada (Alemtuzumab)

French Pharmaceuticals Multinational Sanofi and its subsidiary Genzyme, which which makes Lemtrada, say they strongly disagree with the U.S. Food and Drug Administration’s (FDA) recent rejection of approval of its new Lemtrada (alemtuzumab) drug for treatment of relapsing forms of multiple sclerosis. After receiving a Complete Response Letter from the FDA for its supplemental Biologics License Application seeking approval of ...

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FDA Panel Member From UT Southwestern Greenlights New Crohn’s Disease Treatment

FDA Panel Member From UT Southwestern Greenlights New Crohn’s Disease Treatment

A noted panelist from the University of Texas Southwestern who is a voting member of the Food and Drug Administration’s (FDA) Gastrointestinal Drugs and Drug Safety and Risk Management joint advisory committee, was one of a plurality of votes approving the investigational biologic agent vedolizumab for the treatment of Crohn’s disease, as well as supporting an additional indication for ulcerative colitis. While the ...

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Cystic Fibrosis Treatment Developer Savara Pharmaceuticals’ AeroVanc Receives Key FDA Designations

Cystic Fibrosis Treatment Developer Savara Pharmaceuticals’ AeroVanc Receives Key FDA Designations

Austin-based Savara Pharmaceuticals continues to make significant strides in bringing its impressive AeroVanc antibiotic to market for treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in cystic fibrosis patients. Just last week, BioNews Texas reported on how the company bolstered its Board of Directors with top-flight biotech business development executives in a bid to further increase velocity of its AeroVanc ...

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Fort Worth’s Ampcare Earns FDA Approval For ESP™, A Treatment For Swallowing Disorders

Fort Worth’s Ampcare Earns FDA Approval For ESP™, A Treatment For Swallowing Disorders

Fort Worth, Texas-based incubator TECH Fort Worth (Tech FW) has consistently made headlines with several of its successful clients, such as the recent news that its client RPM2 signed a multi-year, Bronze-Level partnership with USA Triathlon. Now, Ampcare, LLC, another Tech FW client, has announced that the U.S. Food and Drug Administration (FDA) has cleared the company to market its innovative ESP™ ...

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Austin’s Affinium Pharmaceuticals Announces FDA QIDP Designation for AFN-1252, Completion of Dosing of AFN-1720 Phase 1 Trial

Austin’s Affinium Pharmaceuticals Announces FDA QIDP Designation for AFN-1252, Completion of Dosing of AFN-1720 Phase 1 Trial

According to a recent report from Affinium Pharmaceuticals, the company’s lead drug candidate, AFN-1252, has received designation from the U.S. Food and Drug Administration (FDA) as a QIDP (Qualified Infectious Disease Product). This designation will allow the use of the drug for the management of acute infections of the skin and associated skin structures against bacterial agents like MRSA. This step ...

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Repros Receives Guidance From FDA For Upcoming Proellex Clinical Study

Repros Receives Guidance From FDA For Upcoming Proellex Clinical Study

Repros Therapeutics Inc. announced that it has received guidance from the FDA for its clinical trial on Proellex, a drug candidate for the treatment of uterine fibroids. The agency recommended endpoints that are believed to be acceptable for the treatment and instructed Repros to submit a request for lifting of the full clinical hold when it submits a new protocol. ...

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San Antonio-based iTraumaCare Receives FDA Expanded Indication for iTClamp Hemorrhage Control System

San Antonio-based iTraumaCare Receives FDA Expanded Indication for iTClamp Hemorrhage Control System

Canadian-based medical device company iTraumaCare, which maintains a facility in San Antonio, Texas, has successfully achieved another regulatory milestone, as it has been approved by the U.S. Food and Drug Administration (FDA) for expanded indications. The early-stage, advanced medical equipment designed by iTraumaCare mainly deals with introducing qualitative solutions for traumatic injuries. The iTClamp has now also been approved for ...

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Texas Children’s Hospital receives $1.5 Million Grant from FDA for Pediatric Medical Device Consortium

Texas Children’s Hospital receives $1.5 Million Grant from FDA for Pediatric Medical Device Consortium

Texas Children’s Hospital and Baylor College of Medicine (BCM) are part of a consortium that has received a five-year, $1.5 million grant from the U.S. Food and Drug Administration (FDA) to improve the pipeline for the development of pediatric medical devices. Texas Children’s Hospital is a non-profit organization, committed to creating a community of healthy children through excellence in patient ...

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UTSPH Awarded $20 Million From FDA, NIH To Launch Tobacco Regulatory Science Center

UTSPH Awarded $20 Million From FDA, NIH To Launch Tobacco Regulatory Science Center

The University of Texas School of Public Health has received $20 million in funding from the United States Food and Drug Administration (FDA) and the National Institutes of Health (NIH) as part of an ongoing interagency partnership. The UT School of Public Health Austin Regional Campus, part of The University of Texas Health Science Center at Houston (UTHealth), is one ...

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