InspireMD Receives Approval From US Food and Drug Administration to Begin US Regulatory Trial
InspireMD, Inc. (NYSE MKT: NSPR) ("Inspire" or the "Company"), the developer of the MGuard™ Embolic Protection Stent (EPS), announced today that on April 19, 2013, the Company received an approval with conditions for its Investigational Device Exemption (IDE) application with the U.S. Food and Drug Administration (FDA). An approval with conditions indicates that the FDA concurs with the overall trial design and while minor details are being finalized, allows the company to initiate enrollment in the MASTER II IDE trial.
The multi-center, randomized trial will consist of 1,114 patients suffering from ST Elevation Myocardial Infarction (STEMI), throughout 35 sites in the U.S. and an additional 35 sites in Europe, and will support the Company's application to market its MGuard™ Prime MicroNet™ covered coronary stent system in the US.
FDA Approves Neuralstem To Treat Final Cohort In NSI-189 Phase Ib Trial In Major Depressive Disorder
Neuralstem, Inc. (NYSE MKT: CUR) announced that it has received approval from the Food and Drug Administration (FDA) to begin dosing the third and final cohort of patients in its ongoing Phase Ib to test the safety of NSI-189 in the treatment of major depressive disorder (MDD). NSI-189, the lead compound in Neuralstem's neurogenic small molecule platform, is a proprietary new chemical entity that stimulates new neuron growth in the hippocampus, a region of the brain believed to be implicated in MDD, as well as other diseases and conditions such as: traumatic brain injury (TBI), Alzheimer's disease, and post-traumatic stress disorder (PTSD).
FDA Advisory Committee recommends approval of BREO™ ELLIPTA™ for the treatment of COPD
GlaxoSmithKline plc (GSK.L) and Theravance, Inc. (THRX) today announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US Food and Drug Administration (FDA) voted that the efficacy and safety data provide substantial evidence to support approval of BREO™ ELLIPTA™ as a once-daily inhaled treatment for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) (9 for, 4 against) and also for the reduction of COPD exacerbations in patients with a history of exacerbations (9 for, 4 against)*.
BREO™ ELLIPTA™, is the proposed proprietary name for FF/VI 100/25 mcg, a combination of the inhaled corticosteroid (ICS) fluticasone furoate "FF" and the long acting bronchodilator (LABA) vilanterol "VI" (FF/VI).
Neuralstem Receives FDA Approval To Commence Phase II Stem Cell Trial In Amytrophic Lateral Sclerosis
Trial Expands to Two Centers; Approval Includes Significant Increase in Dosing
Neuralstem, Inc. (NYSE MKT: CUR) announced that it has received approval from the Food and Drug Administration (FDA) to commence a Phase II trial using NSI-566 spinal cord-derived human neural stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). This Phase II dose escalation and safety trial will expand to two centers, Emory University Hospital in Atlanta, Georgia, where Phase I was recently completed, and ALS Clinic at the University of Michigan Health System, in Ann Arbor, Michigan, subject to approval by the Institutional Review Board at each institution. The trial is designed to treat up to 15 patients, in five different dosing cohorts.
ACADIA Pharmaceuticals Announces Expedited Path to NDA Filing for Pimavanserin Following Meeting with FDA
Single Pivotal Phase III -020 Study and Other Supportive Data Sufficient for Future NDA Filing for the Treatment of Parkinson’s Disease Psychosis
ACADIA Pharmaceuticals Inc. (ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced that the U.S. Food and Drug Administration (FDA) has agreed that the data from the pivotal Phase III -020 study, together with supportive data from other studies with pimavanserin, are sufficient to support the filing of a New Drug Application (NDA) for the treatment of Parkinson’s disease psychosis (PDP). As a result, ACADIA will no longer conduct the Phase III -021 study that was planned as a confirmatory trial and was scheduled to be initiated later this month.
FDA Grants Fast Track Designation for MediciNova's MN-166 (ibudilast) for the Treatment of Methamphetamine Dependence
MediciNova, Inc., a biopharmaceutical company that is publicly traded on the NASDAQ Global Market (MNOV) and the Jasdaq Market of the Osaka Securities Exchange (Code Number: 4875), today announced that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for MN-166 (ibudilast) for the treatment of methamphetamine dependence. Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended to treat serious diseases and have the potential to fill an unmet medical need. An important feature of the FDA's Fast Track program is that it emphasizes early and frequent communication between the FDA and the sponsor throughout the entire drug development and review process to improve the efficiency of product development. Accordingly, Fast Track status can potentially lead to a shortened timeline to ultimate drug approval.
Repros Reports FDA Recommends Pivotal Study ZA-301 of Androxal(R) to be Completed as Originally Planned FDA recommends all subjects in study ZA-301 complete as per the original protocol FDA accepts additional enrollment into pivotal study ZA-302 SPA for both pivotal trials remains intact
Repros Therapeutics Inc.(R) (RPRX) today provided a clinical update of its Androxal(R) Phase 3 program following receipt of written guidance from the FDA.
The FDA has informed Repros to proceed with the analysis of ZA-301 as previously planned, and that data should be evaluated both with and without patients from the high enrolling site where the patients' baseline characteristics appeared different from other sites in the study.
Pharmacyclics First to Announce Breakthrough Therapy Designation in Oncology from the U.S. Food and Drug Administration
Pharmacyclics, Inc. (the "Company") (PCYC) announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to the investigational oral agent ibrutinib monotherapy for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL) and to ibrutinib monotherapy for the treatment of patients with Waldenstrom's macroglobulinemia (WM), both of which are B-cell malignancies.
BIOLASE Receives FDA Clearance for Its 940nm Diolase 10(TM) Diode Soft Tissue Laser for a Broad Spectrum of Medical Procedures
Clearance for Over 80 Procedures in 19 Additional Medical Markets
BIOLASE, Inc. ( NASDAQ : BIOL ), the world's leading manufacturer and distributor of dental lasers, announced today that the U.S. Food and Drug Administration (FDA) has cleared the 940nm Diolase 10 diode soft tissue laser for use in 19 additional medical markets including: ear, nose and throat, oral surgery, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, GI/GU, gynecology, neurosurgery, ophthalmology, pulmonary surgery, cardiac surgery, thoracic surgery, urology, dermatology, aesthetics, and vascular surgery. This FDA clearance includes over 80 different procedures.
Hyperion Therapeutics' RAVICTI(TM) (glycerol phenylbutyrate) Liquid Receives FDA Approval for Treatment of Urea Cycle Disorders Anticipated market launch by end of April 2013 Patent allowance extends coverage to 2032
Hyperion Therapeutics, Inc. (HPTX) today announced that the U.S. Food and Drug Administration (FDA) has approved RAVICTI for the treatment of Urea Cycle Disorders (UCD) in patients two years of age and older. The drug is expected to be commercially available by the end of April 2013.
EDAP Submits U.S. FDA Pre-Market Approval Application for Ablatherm(R)-HIFU for Treatment of Low Risk, Localized Prostate Cancer
EDAP TMS SA (EDAP), the global leader in therapeutic ultrasound, announced today the submission of its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) on January 31, 2013 for the Company's Ablatherm-HIFU (High Intensity Focused Ultrasound) for treatment of low risk, localized prostate cancer. EDAP's PMA submission includes data from the ENLIGHT study, a multi-center U.S. Phase II/III clinical trial that completed the two year follow-up needed to evaluate its primary endpoint in August 2012, as well as data from the Company's extensive worldwide database of treatment information and follow-up data from patients who have undergone HIFU therapy for prostate cancer.
Keryx Biopharmaceuticals Announces Zerenex™ (ferric citrate) Meets Primary and All Key Secondary Endpoints in Phase 3 Long-Term Study as a Treatment for Hyperphosphatemia in End-Stage Renal Disease Patients on Dialysis
Zerenex Significantly Increases Iron Storage Parameters and Decreases Need for Intravenous Iron and Erythropoiesis-Stimulating Agents Versus Active Control U.S. and European New Drug Application Submissions Anticipated in Second Quarter 2013 Conference Call to Be Held Today, Monday, January 28, 2013, at 8:00 am Eastern Time
Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) today announced successful top-line results from the long-term Phase 3 study of Zerenex™ (ferric citrate), the Company's ferric iron-based phosphate binder drug candidate, for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis.
Furiex Confirms Takeda’s Receipt of FDA Approval of NESINA (alogliptin) and Fixed-Dose Combinations OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl) for the Treatment of Type 2 Diabetes
Furiex Pharmaceuticals, Inc. (FURX) today confirmed that Takeda Pharmaceutical Company Limited has received approval from the U.S. Food and Drug Administration of three new type 2 diabetes therapies, NESINA (alogliptin) and the fixed-dose combination therapies, OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl), for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise.
FDA Clears First Autonomous Telemedicine Robot for Hospitals
RP-VITA™, by iRobot and InTouch Health, enables doctors to provide patient care from anywhere in the world via a telemedicine solution
iRobot Corp. (IRBT), a leader in delivering robotic solutions, announced that the RP-VITA Remote Presence Robot has received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for use in hospitals. RP-VITA is the first autonomous navigation remote presence robot to receive FDA clearance.
RP-VITA is a joint effort between two industry leaders, iRobot and InTouch Health. The robot combines the latest in autonomous navigation and mobility technologies developed by iRobot with state-of-the-art telemedicine and electronic health record integration developed by InTouch Health.
NuPathe's Zecuity Approved by the FDA for the Acute Treatment of Migraine
First FDA-Approved Migraine Patch Conference Call Scheduled January 18 at 8:30 a.m. EST
NuPathe Inc. ( NASDAQ : PATH ) today announced that the U.S. Food and Drug Administration (FDA) has approved Zecuity™ (sumatriptan iontophoretic transdermal system) for the acute treatment of migraine with or without aura in adults. Zecuity is a single-use, battery-powered patch that actively delivers sumatriptan, the most widely prescribed migraine medication, through the skin. Zecuity provides relief of both migraine headache pain and migraine-related nausea (MRN).
Hyperion Notified That FDA Will Not Meet the PDUFA Action Date for Ravicti(TM)
Hyperion Therapeutics, Inc. (HPTX) said that the U.S. Food and Drug Administration (FDA) has advised the Company not to expect a final action by the Prescription Drug User Fee Act (PDUFA) action date of January 23, 2013. The agency explained it is continuing to work on label and post-marketing requirements in connection with Hyperion's New Drug Application (NDA) for Ravicti(TM) (glycerol phenylbutyrate) for the treatment of Urea Cycle Disorders (UCD).
Santarus Receives FDA Approval of UCERIS (Budesonide) for the Induction of Remission in Patients with Active, Mild to Moderate Ulcerative Colitis
Commercial launch expected in March 2013 Company provides 2013 financial guidance
Santarus, Inc. (SNTS) announced today that the U.S. Food and Drug Administration (FDA) has approved UCERIS™ (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis. The company expects to commence the commercial launch of UCERIS in March 2013.
Neuralstem Receives FDA Approval To Commence Spinal Cord Injury Trial
NSI-566 to be tested in patients with chronic spinal cord injury
Neuralstem, Inc. (NYSE MKT: CUR) announced that it received approval from the United States Food and Drug Administration (FDA) to commence a Phase I safety trial of its lead cell therapy candidate, NSI-566, in chronic spinal cord injury patients. This open-label, multi-site study, will enroll up to eight patients with thoracic spinal cord injuries (T2-T12), who have an American Spinal Injury Association (AIS) A level of impairment, between one and two years after injury. AIS A impairment refers to a patient with no motor or sensory function in the relevant segments at and below the injury, and is considered to be complete paralysis.
U.S. Food and Drug Administration approves Cangene's VARIZIG®
Readers are referred to the cautionary notes regarding Forward-Looking Information at the end of this release.
Cangene Corporation ("Cangene") today announces that the United States Food and Drug Administration has approved VARIZIG® [Varicella Zoster Immune Globulin (Human)] for post-exposure prophylaxis of varicella (chickenpox) in high risk patient groups including immunocompromised children, newborns and pregnant women. VARIZIG is intended to reduce the severity of chickenpox infections in these patients.
Aeterna Zentaris Granted Special Protocol Assessment by the FDA for Phase 3 Registration Trial in Endometrial Cancer with AEZS-108
Aeterna Zentaris Inc. (NASDAQ) (TSX: AEZ) (the "Company") today announced that it has reached an agreement with the U.S. Food and Drug Administration ("FDA") on a Special Protocol Assessment ("SPA") for an upcoming Phase 3 registration trial in endometrial cancer with its doxorubicin peptide conjugate, AEZS-108. The SPA agreement states that the proposed trial protocol design, clinical endpoints and planned analyses are acceptable to the FDA to support a regulatory submission.
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