Tag: FDA

Globe Newswire

Aviragen Therapeutics Reports Fourth Quarter and Fiscal Year 2016 Financial Results

ATLANTA, Sept. 14, 2016 (GLOBE NEWSWIRE) — Aviragen Therapeutics, Inc. (NASDAQ:AVIR) today announced its financial results for the fourth quarter and 2016 fiscal year ended June 30, 2016, and also provided an update on recent corporate and clinical developments. “Over the last twelve months we have made significant advances with our three next generation direct-acting antivirals that address serious infections with limited therapeutic options. Enrollment is 90% complete in the SPIRITUS Phase 2b trial of vapendavir for the treatment of human rhinovirus infections in moderate and severe asthmatic patients, and we look forward to announcing top-line data from the trial

Miramar Labs’ miraSmooth Procedure Featured on The Rachael Ray Show

SANTA CLARA, Calif., Sept. 14, 2016 (GLOBE NEWSWIRE) — Miramar Labs, Inc., (OTCQB:MRLB), a global aesthetic company, announced today that its miraSmooth™ treatment was featured in the September 6th episode of “The Rachael Ray Show”, an award-winning and nationally syndicated daytime TV show. The theme of the episode, “Can 3 High-Tech Beauty Treatments Improve Your Problem Areas – Forever?” featured Dr. Whitney Bowe, a New York based board certified dermatologist, highlighting the miraDry/miraSmooth procedure. Dr. Bowe spoke about the benefits of miraSmooth’s microwave technology, including the permanent reduction of underarm sweat and hair of all color. The complete segment featuring

Zynerba Pharmaceuticals Reports Inducement Grant to New Chief Financial Officer

DEVON, Pa., Sept. 13, 2016 (GLOBE NEWSWIRE) — Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today announced that the Company’s Board of Directors granted James Fickenscher, the Company’s newly appointed Chief Financial Officer and Vice President, Corporate Development, an option to purchase 150,000 shares of the Company’s common stock as an inducement material to his acceptance of employment with the Company in accordance with NASDAQ Listing Rule 5635(c)(4).  The option will have an exercise price equal to the closing price of Zynerba Pharmaceuticals’ common stock on September 13,

BioXcel’s BXCL101, Receives Orphan Drug Designation from the U.S. FDA for the Treatment of Patients with Neurofibromatosis Type 2 (NF2)

BRANFORD, Conn., Sept. 13, 2016 (GLOBE NEWSWIRE) — BioXcel, a privately held biopharmaceutical company based in Connecticut, today announced that the U. S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BXCL101 for the treatment of Neurofibromatosis Type 2 (NF2), an orphan disease with significant unmet medical need.  BXCL101 is the first and only systemic therapy being developed to eliminate existing lesions and prevent the formation of new lesions by targeting the molecular mechanism of NF2 pathophysiology. BXCL101 is a proprietary version of an approved drug, bortezomib, adapted for chronic use in NF2 patients with both a

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Vascular Solutions Surpasses 150,000 Successfully Reprocessed ClosureFAST® Catheters

Reprocessing service for varicose vein ablation catheter continues to gain customers nearly five years after launch Excellent record of safety and reliability Reprocessing lowers costs and reduces medical waste for U.S. vein clinics MINNEAPOLIS, Sept. 13, 2016 (GLOBE NEWSWIRE) — Vascular Solutions, Inc. (Nasdaq:VASC) today announced that more than 150,000 ClosureFAST catheters have been successfully reprocessed by its partner, Northeast Scientific, Inc. (NES), since Vascular Solutions launched the reprocessing service for the popular vein ablation catheters in January of 2012. “As we approach the fifth anniversary of the launch of our novel reprocessing service for the ClosureFAST catheter, we are

NanoString Technologies Appoints Kirk Malloy, Ph.D. to Board of Directors

SEATTLE, Sept. 13, 2016 (GLOBE NEWSWIRE) — NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced the appointment of Kirk Malloy, Ph.D. to the company’s Board of Directors, effective September 12, 2016.  The Board now consists of seven members.  Dr. Malloy is a senior healthcare executive with more than 20 years of leadership in life science tools, applied markets and molecular diagnostics. He is currently founder and principal at BioAdvisors, LLC where he provides strategic consulting services to life science, genomic and diagnostic companies. His previous experience includes a 13-year

AGTC Announces Financial Results and Business Update for the Quarter and Fiscal Year Ended June 30, 2016

GAINESVILLE, Fla., and CAMBRIDGE, Mass., Sept. 12, 2016 (GLOBE NEWSWIRE) — Applied Genetic Technologies Corporation (NASDAQ:AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, today announced financial results for the quarter ended June 30, 2016. “Over the past year we’ve continued to make progress across our clinical programs and have remained focused on advancing novel gene-based therapies to improve the lives of patients affected by rare inherited diseases,” said Sue Washer, President and CEO of AGTC. “We are continuing to advance our lead product candidates for X-linked retinoschisis and

pSivida Corp. Provides Company Update and Reports Fourth Quarter and FY 2016 Results

WATERTOWN, Mass., Sept. 12, 2016 (GLOBE NEWSWIRE) — pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug delivery products for treating eye diseases, today provided a Company update and announced financial results for its fourth quarter and fiscal year ended June 30, 2016. “Fiscal 2016 was a year of substantial progress for pSivida.  We significantly advanced Medidur™ for posterior segment uveitis toward planned EU and U.S. marketing applications, progressing toward a treatment with the potential to inhibit the disease for three years from a single injection without significant side effects and without systemic therapy,” said Dr. Paul Ashton, president and chief executive

Adamas Announces Two Data Presentations on ADS-5102 for the Treatment of Levodopa-induced Dyskinesia (LID) at the 4th World Parkinson Congress

EMERYVILLE, Calif., Sept. 12, 2016 (GLOBE NEWSWIRE) — Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced details regarding two poster presentations highlighting data from EASE LID and EASE LID 3, two completed trials from the company’s Phase 3 clinical program of ADS-5102 for the treatment of levodopa-induced dyskinesia (LID) associated with Parkinson’s disease, to be presented at the 4th World Parkinson Congress (WPC) being held in Portland, Oregon, September 20 to 23, 2016. Poster Presentation Details    Title:  Results of a Phase 3 Efficacy and Safety Study of ADS-5102 (amantadine hydrochloride)         Extended-release Capsules in Parkinson’s Disease Patients with

Advanced (3D/4D) Visualization Systems Market to Reach US$ 3.28 Bn in 2024; Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2016 – 2024: TMR

Albany – New York, Sept. 12, 2016 (GLOBE NEWSWIRE) — According to a new market report published by Transparency Market Research “Advanced (3D/4D) Visualization Systems Market (Platform: Ultrasound, MRI, CT, PET, and Others; Application: Cardiology, Oncology, Neurology, and Others; End-user: Hospitals, Diagnostic Labs, and Academics & Research) – Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2016–2024”, the global advanced (3D/4D) visualization systems market was valued at US$ 1.8 Bn in 2015 and is projected to expand at a CAGR of 6.4% from 2016 to 2024 to reach US$ 3.2 Bn in 2024. Interpret a Competitive outlook Analysis Report with free

CytoDyn Announces $10.0 Million Registered Direct Offering

VANCOUVER, Washington, Sept. 12, 2016 (GLOBE NEWSWIRE) — CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, today announced that it has entered into definitive agreements with healthcare dedicated institutional investors for an offering of 13,333,334 shares of common stock, at a price per share of $0.75, and warrants to purchase 6,666,667 shares of common stock with gross proceeds of approximately $10.0 million in a registered direct offering.  The warrants have an exercise price of $1.00 per share and will expire five years from the date of issuance. The closing

Flexion Therapeutics Announces Two Key Corporate Appointments

BURLINGTON, Mass., Sept. 12, 2016 (GLOBE NEWSWIRE) — Flexion Therapeutics, Inc. (Nasdaq:FLXN) announced today that it has made two key appointments to its leadership team: Carolyn Beaty Scimemi, Esq., an experienced compliance and legal professional, as Chief Compliance Officer, and Adam Muzikant, Ph.D., a veteran biotechnology deal negotiator and strategist, as Vice President, Business Development. Ms. Scimemi and Dr. Muzikant join the Flexion leadership team as the company prepares to submit a planned new drug application (NDA) in the fourth quarter of 2016 to the U.S. Food and Drug Administration (FDA) for its drug candidate Zilretta™ (also known as FX006),

Cellectar Biosciences Announces Lead Compound CLR 131 To Be Studied In Head and Neck Cancer in $12M University of Wisconsin SPORE Grant

MADISON, Wis., Sept. 12, 2016 (GLOBE NEWSWIRE) — Cellectar Biosciences, Inc. (Nasdaq:CLRB) (“the company”), an oncology-focused biotechnology company, today announces that its lead therapeutic compound, CLR 131, currently in a Phase 1 clinical trial for multiple myeloma and preparing for a Phase 2 study in multiple myeloma and other hematologic malignancies, will be evaluated by the University of Wisconsin in combination with external beam radiation as a potential combination treatment for head and neck cancers (squamous cell carcinoma).  The research will be conducted as part of a Specialized Program of Research Excellence (SPORE) grant, awarded to the University of Wisconsin

Celsion Corporation Announces Independent NIH Analysis Showing Treatment with ThermoDox® Plus RFA May Significantly Improve Overall Survival of Patients with Primary Liver Cancer

Conclusions Drawn from Results of Celsion’s HEAT Study Prompted NIH Analysis; Prior Subgroup Analysis of HEAT Study by Celsion Demonstrated a Two-Year Overall Survival Benefit Compared to Treatment with RFA Alone Abstract Accepted for Oral Presentation at the 2016 RSNA Annual Meeting LAWRENCEVILLE, N.J., Sept. 12, 2016 (GLOBE NEWSWIRE) — Celsion Corporation (NASDAQ:CLSN) today announced that the National Institutes of Health (NIH) has conducted an independent retrospective analysis of data from the intent-to-treat population of the Company’s HEAT Study, a 701-patient study investigating ThermoDox®, Celsion’s proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radiofrequency ablation (RFA) in primary liver cancer, also

Aptose Submits Formal Response to Clinical Hold for APTO-253

SAN DIEGO and TORONTO, Sept. 12, 2016 (GLOBE NEWSWIRE) — Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, announced today that it has submitted a formal response to the U.S. Food and Drug Administration (FDA) regarding the previously announced clinical hold of Aptose’s Phase 1b clinical trial of APTO-253 in patients with hematologic cancers.  Aptose provided responses to all of the questions cited in the clinical hold letter issued by the FDA. “This submission represents months of disciplined labor to resolve a manufacturing matter related to APTO-253

Inovio’s Zika Vaccine Selected As 2016 Technology Breakthrough

PLYMOUTH MEETING, Pa., Sept. 12, 2016 (GLOBE NEWSWIRE) — Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that its Zika vaccine in development has been named a 2016 Technology Breakthrough by the editors of Popular Mechanics magazine, the leading technology voice in the U.S. with millions of readers. Inovio has advanced its DNA-based Zika vaccine into two trials in the U.S., Canada and Puerto Rico. Inovio expects to have results before the end of this year for its U.S. study.  In addition, the CDC estimates Zika will infect more than 25% of the Puerto Rican population by year end, providing the potential

TESARO Receives FDA Fast Track Designation for Niraparib and Initiates Rolling NDA Submission

WALTHAM, Mass., Sept. 12, 2016 (GLOBE NEWSWIRE) — TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to niraparib for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. TESARO has initiated a rolling submission of a New Drug Application (NDA) for niraparib to the FDA, and intends to complete this submission during the fourth quarter. The Marketing Authorization Application (MAA) for niraparib is planned for submission to the European Medicines Agency (EMA) in the fourth quarter. The FDA Fast Track designation

Amarin’s REDUCE-IT Cardiovascular Outcomes Study of Vascepa to Continue as Planned at Recommendation of Independent Data Monitoring Committee

BEDMINSTER, N.J. and DUBLIN, Ireland, Sept. 12, 2016 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) announced that, as expected, the independent data monitoring committee (DMC) has completed its review of the first pre-specified interim efficacy analysis for the REDUCE-IT cardiovascular outcomes study and has recommended that the trial continue as planned without modification. The 8,175-patient outcomes study is evaluating whether treatment with Vascepa® (icosapent ethyl) reduces cardiovascular events in patients who despite stabilized statin therapy have elevated triglyceride levels and other cardiovascular risk factors. In accordance with the study protocol, the first interim efficacy analysis was performed after adjudication of

Adamas Announces New Employment Inducement Grant

EMERYVILLE, Calif., Sept. 09, 2016 (GLOBE NEWSWIRE) — Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that its new Vice President of Corporate Communications and Investor Relations, Martin Forrest, received a grant of an option to purchase 31,875 shares of the company’s common stock, at a per share exercise price of $16.13, the closing trading price on September 8, 2016, and 5,313 restricted stock units, pursuant to the terms of his employment agreement with Adamas.  The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by

Review of Xtampza® ER Published in The Journal of the American Medical Association

CANTON, Mass., Sept. 09, 2016 (GLOBE NEWSWIRE) — Collegium Pharmaceutical, Inc. (Nasdaq:COLL) today announced the publication of an independent review of Xtampza® ER in The Journal of the American Medical Association (JAMA).  The review titled, “A New Abuse-Deterrent Opioid–Xtampza ER”, was previously published in The Medical Letter.  JAMA is one of the most widely read medical journals in the world and The Medical Letter is widely recognized for its unbiased information about drug therapy.  Through a collaboration, one article each month is chosen by the editors for publication in both journals. The publication can be found here. About Collegium Pharmaceutical, Inc.