ARCA biopharma Announces US FDA Acceptance of Gencaro IND Application for the Treatment of Atrial Fibrillation
Phase 2B/3 GENETIC-AF Trial on Track to Begin Patient Enrollment in Q1 2014 Gencaro Potentially the First Genetically-Targeted Cardiovascular Treatment
ARCA biopharma, Inc. (ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that the Company’s GencaroTM Investigational New Drug (IND) application for atrial fibrillation (AF) has been accepted by the U.S. Food and Drug Administration (FDA) and is now active.
Oculus Innovative Sciences Receives FDA Clearance for Microcyn(R) Scar Management HydroGel
Oculus U.S Dermatology Partner, Quinnova Pharmaceuticals, Targeting U.S. Launch in Q2 2014
U.S. Double-Blind, Randomized Study for Scar Management Establishes Strong Foundation for International Approval
Oculus Innovative Sciences, Inc. (OCLS), a global healthcare company that designs, manufactures and markets prescription and non-prescription products in 27 countries, today announced that it has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company's new Microcyn(R) Scar Management HydroGel.
Conatus Pharmaceuticals Receives U.S. Orphan Drug Designation for Emricasan for Treatment of Liver Transplant Recipients With Reestablished Fibrosis
Conatus Pharmaceuticals Inc. (CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Conatus' drug candidate emricasan for the treatment of liver transplant recipients with reestablished fibrosis to delay the progression to cirrhosis and end-stage liver disease. The FDA's Orphan Drug Designation program is intended to encourage the development of drugs and biologics that may provide benefit to patients suffering from rare diseases or conditions.
Ampio Receives FDA Confirmation that The Spring Study is Pivotal and Will Initiate the Final Pivotal Trial for Ampion™ Biological License Application (BLA)
Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced receipt of FDA correspondence confirming the acceptance of The Spring Study as pivotal and providing guidance for the design of the second and final pivotal trial of Ampion™ for the treatment of osteoarthritis of the knee (OAK).
Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, noted the letter summarized the FDA's conclusions after reviewing the complete clinical data set provided by Ampio following their October 29th pre-BLA meeting. The FDA letter includes the following statements:
Cardiovascular Systems, Inc. Receives Coronary FDA Approval
Diamondback 360® Coronary Orbital Atherectomy System Approved to Treat Severely Calcified Coronary Lesions Controlled Commercial Launch to begin immediately
Cardiovascular Systems, Inc. (CSI) (CSII), today announced that it has received PMA approval from the U.S. Food and Drug Administration (FDA) to market its Diamondback 360® Coronary Orbital Atherectomy System (OAS) as a treatment for severely calcified coronary arteries.
“Today is a landmark moment for: patients suffering from calcified coronary artery disease, their families, our physician operators and everyone at CSI,” said David L. Martin, President and Chief Executive Officer of Cardiovascular Systems. “FDA approval of our Diamondback 360 Coronary OAS allows us to bring to market the first new coronary atherectomy system in more than two decades.”
Oxygen Biotherapeutics Signs Agreement to Acquire Phase 3, FDA Fast Track Product to Pursue Potential $600 Million Cardiovascular Market
Phyxius Pharma’s Experienced Management Team Brings Exclusive Rights to Levosimendan with FDA Fast Track Status and Agreed Protocol to Begin Phase 3 Trial
Oxygen Biotherapeutics, Inc., (OXBT) a developer of oxygen-carrying therapeutics, today announced it has signed a Definitive Agreement (“Agreement”) to acquire certain assets of Phyxius Pharma, a privately-held biopharmaceutical company focused on the development and near-term commercialization of levosimendan to prevent and treat cardiac surgery patients at risk for developing low cardiac output syndrome (LCOS), a significant unmet medical need addressing an estimated $600 million market in the U.S.
FDA Agrees with Omeros' Pediatric Study Plan for OMS302
-- Completion of Pediatric Study Can Lead to Additional Marketing Exclusivity -
Omeros Corporation (OMER) today announced that the U.S. Food and Drug Administration (FDA) confirmed its agreement with the Pediatric Study Plan (PSP) proposed by Omeros to study the use of OMS302 in pediatric patients undergoing primary cataract extraction. The FDA also issued a Written Request consistent with the PSP, which means that successful completion of the PSP would make OMS302 eligible for an additional six months of marketing exclusivity in the U.S. Added to standard irrigation solution used during ophthalmological procedures, OMS302 is Omeros' proprietary PharmacoSurgery® product designed to maintain intraoperative mydriasis (pupil dilation), prevent surgically induced miosis (pupil constriction), and reduce postoperative pain resulting from cataract and other lens replacement surgery.
Discovery Labs Announces FDA Approval of SURFAXIN® (lucinactant) Updated Product Specifications
Commercial Introduction of SURFAXIN Planned for the Fourth Quarter of 2013 Discovery Laboratories, Inc. (DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced the U.S. Food and Drug Administration (FDA) has agreed to the Company's updated product specifications for SURFAXIN® (lucinactant) Intratracheal Suspension which was approved for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. The Company has initiated manufacturing of SURFAXIN for its planned commercial introduction in the fourth quarter of 2013. SURFAXIN is the first FDA-approved synthetic, peptide-containing surfactant available for the prevention of RDS in premature infants and the only approved alternative to animal-derived surfactants currently used today.
Catalyst Pharmaceutical Partners Receives Breakthrough Therapy Designation From FDA for Firdapse(TM) for the Treatment of LEMS
Catalyst Pharmaceutical Partners, Inc. (CPRX), a specialty pharmaceutical company focused on the development and commercialization of novel prescription drugs targeting rare (orphan) neuromuscular and neurological diseases, today announced that its investigational product Firdapse(TM) (amifampridine phosphate) has received "Breakthrough Therapy Designation" by the U.S. Food and Drug Administration (FDA) for the symptomatic treatment of patients with Lambert-Eaton Myasthenic Syndrome (LEMS). Firdapse(TM) is Catalyst's investigational therapy that is being evaluated for the treatment of the debilitating symptoms associated with LEMS, including muscle weakness.
Supernus Announces Final FDA Approval and Upcoming Launch of Trokendi XR(TM)
Supernus Pharmaceuticals, Inc. (SUPN), a specialty pharmaceutical company, received final approval from the Food & Drug Administration (the "FDA") for Trokendi XR, a novel once-daily extended release formulation of topiramate for the treatment of epilepsy. The company expects to launch the product and for it to be available in pharmacies over the next few weeks.
The approval letter states that the FDA has completed its review of the application and that Trokendi XR is approved effective August 16, 2013 for use as recommended in the agreed-upon labeling. The FDA granted a waiver for certain pediatric study requirements and a deferral for submission of post-marketing pediatric pharmacokinetic assessments that are due in 2019 followed by clinical assessments in 2025.
FDA Accepts Tasimelteon New Drug Application For Priority Review In The Treatment Of Non-24-Hour Disorder In The Totally Blind
Vanda Pharmaceuticals Inc. (VANDA) (VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing and granted a priority review classification to Vanda's New Drug Application (NDA) for tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder (Non-24) in the totally blind.
The FDA grants priority review status for a "drug that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness" over current therapies. Currently, there is no approved treatment for Non-24 and tasimelteon has the potential to address this unmet medical need.
Stereotaxis Receives FDA Clearance of Vdrive(TM) with V-Sono(TM) System
Strengthens Niobe(R) Adoption and Opens Growing ICE Catheter Market to Company
Stereotaxis, Inc. (STXS) announced today that it has been granted 510(k) clearance by the Food and Drug Administration (FDA) to market its Vdrive(TM) Robotic Navigation System with V-Sono(TM) Intracardiac Echocardiography (ICE) catheter manipulator in the U.S. This represents the first FDA clearance for the Vdrive family of products, which has been utilized in Europe since 2011.
Chelsea Therapeutics Announces FDA Acceptance of NORTHERA(TM) (droxidopa) NDA Resubmission
Chelsea Therapeutics International, Ltd. (CHTP) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the New Drug Application (NDA) resubmission seeking approval to market NORTHERA(TM) (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy. The FDA has deemed the resubmission a complete response to its March 28, 2012 Complete Response Letter and assigned a new Prescription Drug User Fee Act (PDUFA) goal date of January 3, 2014.
FDA Grant Fast Track Designation to ELND005 for the Treatment of Neuropsychiatric Symptoms in Alzheimer's Disease
Transition Therapeutics Inc. ("Transition" or the "Company") (NASDAQ: TTHI, TSX: TTH) announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to the development program for ELND005 which was submitted for the treatment of Neuropsychiatric Symptoms (NPS) in Alzheimer's disease (AD). The FDA concluded that the development program for ELND005 for the treatment of NPS in AD meets their criteria for Fast Track Designation.
Transition's licensing partner, Elan Corporation, plc ("Elan"), is responsible for all development and commercialization activities and costs of ELND005.
Raptor's PROCYSBI(TM) Receives U.S. Orphan Drug Exclusivity
June 25, 2013 - Raptor Pharmaceutical Corp. (RPTP) today announced that the Office of Orphan Product Development at the Food and Drug Administration (FDA) granted Raptor orphan drug exclusivity for PROCYSBI(TM) (cysteamine bitartrate) delayed-release capsules for the management of nephropathic cystinosis patients age six and older. The exclusivity period began on the date of FDA approval, April 30, 2013, and lasts seven years subject to certain exceptions.
"This decision was the outcome of a productive and cooperative process with the FDA. We believe the issuance of orphan drug exclusivity highlights an appreciation that PROCYSBI is an important new therapeutic option for nephropathic cystinosis patients," stated Thomas E. Daley, chief business officer of Raptor. "The exclusivity also adds incremental protection alongside our issued patents listed in the FDA's Orange Book with expirations in 2027."
Salix and Progenics Announce FDA Advisory Committee to Review Relistor sNDA for Opioid-Induced Constipation in Patients with Chronic Pain
Salix Pharmaceuticals, Ltd. (SLXP) and Progenics Pharmaceuticals (PGNX) today announced that the FDA is seeking input from an Advisory Committee on Salix's Supplemental New Drug Application (sNDA) for RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection, for opioid-induced constipation, or OIC, in patients with chronic pain.
The FDA's action to convene an Advisory Committee was taken in response to the formal appeal by Salix of the complete response action taken by the FDA on July 27, 2012 regarding the RELISTOR sNDA for chronic pain. The FDA has said that it will take action under the appeal after receiving input from the Advisory Committee. The FDA will notify the Company once the Advisory Committee meeting date has been determined.
Avanir Pharmaceuticals Announces Accelerated Development Path for AVP-786 Following Successful Pre-IND Meeting with FDA
Expedited Development Path will Allow Seamless Integration of AVP-786 into ongoing Clinical Programs
Avanir Pharmaceuticals, Inc. (AVNR) today announced that the U.S. Food and Drug Administration (FDA) has agreed to an expedited development pathway for their next-generation compound, AVP-786, requiring only a limited pre-clinical package as part of the Investigational New Drug (IND) application. Upon completion of these preclinical studies the company intends to proceed directly into human clinical trials.
Flamel Technologies Announces FDA Approval of Bloxiverz
Flamel Technologies (NASDAQ: FLML) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for Bloxiverz™ (neostigmine methylsulfate), a drug used intravenously in the operating room for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Flamel expects to launch Bloxiverz™ in July 2013 in 0.5 and 1.0 mg/mL strengths.
"We are extremely excited and pleased to receive this FDA approval for Bloxiverz™, the first product from the portfolio of Éclat products acquired in March 2012," said Mike Anderson, Chief Executive Officer of Flamel.
Medtronic Garners First-Of-Its-Kind FDA Approval for 'AUI' Device with Endurant II AAA Stent Graft System
Global Market-Leader in Medical Technology for Endovascular Aortic Repair Also Receives 510(k) Clearance for Sentrant Introducer Sheath
MINNEAPOLIS -- May 30, 2013 -- Medtronic, Inc. (MDT) is expanding its market-leading portfolio of products for endovascular aortic repair in the United States with two new medical devices: the company recently received approval from the U.S. Food and Drug Administration (FDA) for the Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System and the FDA`s 510(k) clearance for the Sentrant Introducer Sheath; both devices will be on exhibit at the Medtronic booth during the Society for Vascular Surgery`s "Vascular Annual Meeting," which runs May 30-June 2 in San Francisco.
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.
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