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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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San Antonio-Based America Stem Cell, Inc. Receives FDA Clearance for Multi-Center Nationwide Trial

San Antonio-Based America Stem Cell, Inc. Receives FDA Clearance for Multi-Center Nationwide Trial

America Stem Cell, Inc., a privately-held biotechnology company based in San Antonio, TX, announced this week in BUSINESS WIRE, San Antonio, that it has received clearance from the FDA to carry out a Phase I/IIa multi-center for the evaluation of  ASC-101 with dual-umbilical cord transplantation in patients with hematologic malignancies and myelodysplastic syndrome. For many patients with leukemia or lymphomas, ...

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FDA Advisory Committee Considers sNDA For Vascepa, A Treatment For Triglycerides With Mixed Dyslipidemia

FDA Advisory Committee Considers sNDA For Vascepa, A Treatment For Triglycerides With Mixed Dyslipidemia

Amarin Corporation, a biopharmaceutical company that provides therapeutics for cardiovascular health, was recently informed by the U.S. Food and Drug Administration (FDA) that they will hold an advisory committee on October 16th 2013 in connection with the FDA’s review of the Supplemental New Drug Application (sNDA) for the approval of Vascepa® (icosapent ethyl) capsules. The drug will be supplied as ...

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Lifespan-Extending Drug Rapamycin Slowed, Reversed Age-Related Heart Disease in Mice

Lifespan-Extending Drug Rapamycin Slowed, Reversed Age-Related Heart Disease in Mice

Rapamycin, an FDA-approved immunosuppressant drug to help prevent organ rejection after transplantation and to treat some cancers, showed significant improvement of cardiac function in elderly mice suffering from age-related heart disease just in three months, according to a recent study. The study was led by a team of scientists at the Buck Institute for Research on Aging, which included contributions ...

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Houston’s Texas Heart Institute Completes Investigational Procedure In New FDA-Approved Clinical Trial Using Fat-Derived Regenerative Cells on Heart Failure Patients

Houston’s Texas Heart Institute Completes Investigational Procedure In New FDA-Approved Clinical Trial Using Fat-Derived Regenerative Cells on Heart Failure Patients

Doctors at the Texas Heart Institute (THI) and St. Luke’s Episcopal Hospital (SLEH) in Houston, Texas, have completed an investigational procedure on six patients with chronic heart failure in a FDA-approved clinical trial to evaluate the therapeutic effectiveness of adipose-derived regenerative cells (ADRCs). The “ATHENA” clinical trial is the first study in the United States using ADRCs invented by Cytori Therapeutics, a ...

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Houston’s Arcos Medical Receives FDA Approval for Army-Backed Burn Navigator

Houston’s Arcos Medical Receives FDA Approval for Army-Backed Burn Navigator

Arcos Medical, a Houston, Texas based company, has just received the green light from the U.S. Food and Drug Administration (FDA) for its Burn Navigator device. This medical device was developed by the University of Texas along with other burn research institutions across the country in conjunction with the U.S. Army (the device is patented by the U.S. government), and ...

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Texas Firm’s BiO2 Medical Inc. Angel Catheter Device Study Receives FDA Go Ahead

Texas Firm’s BiO2 Medical Inc. Angel Catheter Device Study Receives FDA Go Ahead

San Antonio based medical device manufacturer BiO2 Medical Inc. have received U.S. Food and Drug Administration (FDA) approval of their Investigational Device Exemption (IDE) application to begin an Early Feasibility Pilot Study (EFPS) using their Angel Catheter product. BiO2′s Angel Catheter is a truly retrievable IVC filter permanently attached to a multi-lumen central venous access catheter. Te device is intended ...

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FDA approves PCC to reverse warfarin-induced acute bleeding

FDA approves PCC to reverse warfarin-induced acute bleeding

Long standing and poorly managed warfarin intake is highly associated with complications like major bleeding that is difficult to control in case of severe hemorrhage. However, the recent FDA Approval of Kcentra after Pivotal Clinical Trial under Dr. Ravi Sarode suggests that the intake of PCC can lead to the reversal of acquired coagulation factor deficiency in warfarin treated individuals. ...

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Fort Worth Based Alcon Announces FDA Approval of Simbrinza Suspension, A New Beta Blocker-free, Fixed-Combination Therapy For Glaucoma

Fort Worth Based Alcon Announces FDA Approval of Simbrinza Suspension, A New Beta Blocker-free, Fixed-Combination Therapy For Glaucoma

Fort Worth based Alcon, a division of Novartis, has announced US FDA approval for Simbrinza Suspension, a new beta blocker-free, fixed-combination therapy for glaucoma patients, indicated for the reduction of elevated IOP in patients with primary open-angle glaucoma or ocular hypertension. Alcon, which provides a broad spectrum of pharmaceutical and surgical glaucoma treatment solutions to address patient needs at all ...

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San Antonio-based DPT Laboratories Fixes FDA Violations

San Antonio-based DPT Laboratories Fixes FDA Violations

DPT Laboratories, a pharmaceutical company based in San Antonio, Texas, has made amends for violations against manufacturing standards levied by the U.S. Food and Drug Administration. In announcing the FDA’s letter last Tuesday, DPT Laboratories assured federal regulators and the public that the company would continue to provide significant capital to sustain compliance, having already spent more than $40 million to expand and ...

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UT Southwestern Medical School Researcher Leads ADMA Biologics’ Enrollment In RI-002 Phase III Study For PIDD

UT Southwestern Medical School Researcher Leads ADMA Biologics’ Enrollment In RI-002 Phase III Study For PIDD

ADMA Biologics, Inc. (ADMA) has announced a new advancement in the efficacy and safety evaluation of its novel immunoglobulin RI-002. Adam S. Grossman, President and CEO of ADMA Biologics, announced that the patient enrollment process for Phase III clinical trials of RI -002 has begun and the first patient has been dosed with the immunoglobulin. The Phase III trial is being ...

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UT Health Researchers Find Low Incidence Of Venous Insufficiency In MS

UT Health Researchers Find Low Incidence Of Venous Insufficiency In MS

Chronic cerebrospinal venous insufficiency (CCSVI or CCVI), a term proposed by Italian neurosurgeon and researcher Dr. Paolo Zamboni, M.D. in 2008 to describe compromised flow of blood in the veins draining the central nervous system and hypothesized as a factor in development of multiple sclerosis (MS), is nothing if not controversial. MS is an unpredictable, progressive, immune-mediated disorder of the ...

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