Omidria® Approved for Commercialization Throughout the European Union and price Additional Countries
SEATTLE, Aug. 3, 2015 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that the European Commission (EC) has granted marketing authorization for Omidria (phenylephrine and ketorolac injection) 1% / 0.3% in the European Union (EU) for use in cataract surgery and lens...
Independent Results Show that BiondVax's Universal Flu Vaccine Administered in a Trial 3 Years ago Improves Immunogenicity Against Current Flu H3N2 Epidemic
NESS ZIONA, Israel, August 3, 2015 /PRNewswire/ --
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) today announced it received the statistical analysis of results from a study which demonstrates that BiondVax's universal flu vaccine (M-001), administered in the BVX-005 phase II...
FDA Approves Bayer's Finacea® (azelaic acid) Foam, 15% for the Topical Treatment of the Inflammatory Papules and Pustules of Mild to Moderate Rosacea
WHIPPANY, N.J., July 31, 2015 /PRNewswire/ -- Bayer HealthCare today announced that the U.S. Food and Drug Administration (FDA) has approved Finacea® (azelaic acid) Foam, 15% for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. The...
Mundipharma EDO GmbH Announces FDA Investigational New Drug Approval of its First Anti-Cancer Compound, EDO-S101, for the Treatment of Patients with Relapsed/Refractory Haematologic Malignancies and Solid Tumours
BASEL, Switzerland, July 31, 2015 /PRNewswire/ --
First in human clinical trials to commence Q3 2015
Mundipharma EDO GmbH (Early Development in Oncology) is pleased to announce that the United States Food and Drug Administration ("FDA") has accepted the company's Investigational...
Halaven® (éribuline) : Eisai dépose des demandes d'enregistrement simultanément aux Etats Unis, au Japon et UE pour le traitement du sarcome des tissus mous
HATFIELD, Angleterre, July 31, 2015 /PRNewswire/ --
Une demande de variation de type II a ete soumise en union europeenne, pour l'extension d'indication d' Halaven® (eribulin) dans le traitement des patients atteints de sarcome des tissus mous, non resecable ayant recu au...
Eisai solicita autorización en la Unión Europea, Estados Unidos y Japón para una nueva indicación de Halaven® (eribulina) en sarcoma de tejidos blandos
HATFIELD, Inglaterra, July 31, 2015 /PRNewswire/ --
SOLO PARA LOS MEDIOS DE LA REGIÓN EMEA: NO PARA LOS MEDIOS SUIZOS/AUSTRÍACOS/ESTADOUNIDENSES
Se ha presentado una variación de tipo II ante la Unión Europea para ampliar la indicación de Halaven®...
Eisai reicht in den USA, Japan und der EU einen Antrag für eine neue Indikation für Halaven® (Eribulin) bei Weichteilsarkomen ein
HATFIELD, Großbritannien, July 31, 2015 /PRNewswire/ --
NUR FÜR MEDIEN AUS EMEA-LÄNDERN. NICHT FÜR JOURNALISTEN AUS DER SCHWEIZ//ÖSTERREICH/DEN USA JOURNALISTEN
Eine Typ 2 Variation zur Beantragung der Erweiterung der Indikation von Halaven®...
Eisai presenterà la richiesta di autorizzazione all'immissione in commercio di Halaven® (Eribulina) per il sarcoma dei tessuti molli negli Stati Uniti e in Giappone
HATFIELD, Inghilterra, July 31, 2015 /PRNewswire/ --
DESTINATO ESCLUSIVAMENTE AI MEDIA DELL'AREA EMEA: NON DESTINATO AI GIORNALISTI DI SVIZZERA/AUSTRIA/STATI UNITI
In data odierna verrà presentata la richiesta di autorizzazione all'immissione in commercio nell'Unione europea...
"Vorstellung der Guten Authentifizierungspraxis GAP TM von Aegate in Krankenhausapotheken"
MELBOURN, England, July 30, 2015 /PRNewswire/ --
Das GAP-Protokoll wurde im Rahmen des FMD Academic Pilot Project in Oxford entwickelt, das den ersten Echtzeit-FMD-Arzneimittel-Verifizierungsprozess über einen Krankenhausapothekendienst darstellt, der mehrere Krankenhäuser...
"Présentation des bonnes pratiques d'authentification d'Aegate (Good Authentication Practice GAP™) dans les dispensaires hospitaliers"
MELBOURN, Angleterre, July 30, 2015 /PRNewswire/ --
Le protocole GAP a été développé par le biais des activités du projet pilote académique de la FMD à Oxford qui est le premier processus de vérification des médicaments en direct de la FMD...
"Introduzione di GAP™ (Good Authentication Practice) Aegate nei dispensari ospedalieri"
MELBOURN, Inghilterra, July 30, 2015 /PRNewswire/ --
Il protocollo GAP è il risultato delle attività del Progetto accademico pilota a sostegno della FMD condotto a Oxford, ovvero il primo processo attivo di verifica dei medicinali provato in un dispensario ospedaliero che serve...
"Introductie van de Good Authentication Practice GAP™ van Aegate in ziekenhuisapotheken"
MELBOURN, Engeland, July 30, 2015 /PRNewswire/ --
Het GAP-protocol is ontwikkeld in verband met de activiteiten van het academisch proefproject voor FMD in Oxford, dit is het eerste live geneesmiddelenverificatieproces via een ziekenhuisapotheekdienst voor meerdere...
"Presentación de las buenas prácticas de autentificación (por sus siglas en inglés, Good Authentication Practice, GAP™) en farmacias hospitalarias"
MELBOURN, Inglaterra, July 30, 2015 /PRNewswire/ --
El protocolo de buenas prácticas se ha desarrollado a través de las actividades del Proyecto académico piloto del FMD en Oxford, primer proceso de verificación en tiempo real del FDM que se realiza a través del...
NanoSmart Receives Second FDA Orphan Drug Designation for Treatment of Pediatric Cancer
LAGUNA HILLS, Calif., July 30, 2015 /PRNewswire/ -- NanoSmart Pharmaceuticals, Inc., a private pharmaceutical company developing nanoparticle drug delivery platforms, has received Orphan Drug Designation from the Food and Drug Administration (FDA) for a second drug product that uses...
D-Pharm Receives Final Report for Phase 2 Clinical Study of DP-b99 in Acute High-Risk Pancreatitis Patients
REHOVOT, Israel, July 30, 2015 /PRNewswire/ --
D-Pharm Ltd (TASE:DPRM) announced today July 30th 2015, final positive results from a pilot Phase 2 study of DP-b99 in acute pancreatitis. This was the first clinical study exploring DP-b99 in patients with acute high-risk inflammation of...
Roche submits filing to FDA for companion diagnostic for non-small cell lung cancer drug therapy
PLEASANTON, Calif., July 30, 2015 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced it has submitted the cobas® EGFR Mutation Test v2 for Premarket Approval (PMA) to the U.S. Food and Drug Administration (FDA), as a companion diagnostic test for AZD9291, an...
KaloBios Announces FDA Clearance of Investigational New Drug Application for KB003 in Patients with Chronic Myelomonocytic Leukemia
SOUTH SAN FRANCISCO, July 29, 2015 /PRNewswire/ -- KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO), a monoclonal antibody company focused on developing innovative therapies to benefit patients with diseases of unmet medical need, with a focus on oncology, announced today that the U.S....
New FDA-Approved Device For Treatment Of Drug-Resistant Epilepsy Now Offering Hope To Patients In U.S.
HOUSTON, July 29, 2015 /PRNewswire/ -- In just one month following FDA approval of the AspireSR® generator for the VNS Therapy® System, leading hospitals across approximately 40 states have begun providing this new treatment option for patients with drug-resistant epilepsy....
Lightlake Therapeutics Inc. Announces Adapt Pharma Limited Submits NDA To FDA For Narcan® (naloxone) Nasal Spray
NEW YORK, July 29, 2015 /PRNewswire/ -- Lightlake Therapeutics Inc. ("Lightlake") (OTCQB: LLTP), a specialty pharmaceutical company developing addiction treatments based on its expertise in opioid antagonists, announced today that Adapt Pharma Limited ("Adapt"), Lightlake's partner...
inSleep® Health's Cloud9® Anti-Snoring System Receives FDA Clearance
WESTON, Fla., July 28, 2015 /PRNewswire/ -- inSleep® Health announced today that it has received 510(K) clearance for the company's Cloud9® Anti-Snoring System. The indication for use is to reduce or eliminate simple snoring in adults. Cloud9 is a...
FDA Approves The ReShape™ Integrated Dual Balloon System, A First-Of-Its-Kind Non-Surgical Weight Loss Procedure For People With Mild To Moderate Obesity
SAN CLEMENTE, Calif., July 28, 2015 /PRNewswire/ -- ReShape Medical® today announced that the U.S. Food and Drug Administration (FDA) has approved the ReShape™ Integrated Dual Balloon System, a first-of-its-kind non-surgical weight loss procedure for people with mild to...
ChiRhoClin, Inc. announces Secretin drug shortage resolved; ChiRhoStim® (Human Secretin for Injection) is now available
BURTONSVILLE, Md., July 28, 2015 /PRNewswire/ -- During the past 5 years, ChiRhoClin, Inc. has worked directly with the Food and Drug Administration, CDER, the Drug Shortage Team, and the Office of Pharmaceutical Quality (OPQ) to resolve the shortage of ChiRhoStim® (Human...
U.S. FDA Accepts for Review CSL Behring's Biologics License Application for Its Novel rVIII-SingleChain Therapy for Patients with Hemophilia A
KING OF PRUSSIA, Pa., July 28, 2015 /PRNewswire/ -- CSL Behring announced today that the U.S. Food and Drug Administration has accepted for review the company's Biologics License Application (BLA) for its novel investigational recombinant factor VIII single-chain (rVIII-SingleChain) for...
Kerastem Receives Conditional Approval from FDA for Alopecia Trial
SAN DIEGO, July 28, 2015 /PRNewswire/ -- Kerastem Technologies announce that the Company has received notice of conditional approval from the U.S. FDA Center For Biologics Evaluation and Research (CBER) Office of Cellular, Tissue and Gene Therapies to conduct a clinical trial...
FDA Grants Breakthrough Therapy Designation to Eisai's Lenvatinib for the Potential Treatment of Metastatic Renal Cell Carcinoma
WOODCLIFF LAKE, N.J., July 28, 2015 /PRNewswire/ -- Eisai Inc. announced today the U.S. Food and Drug Administration (FDA) granted lenvatinib, the company's multiple receptor tyrosine kinase inhibitor, Breakthrough Therapy designation for the investigational use in patients with advanced...
Upsher-Smith's ANDROXY™ (Fluoxymesterone Tablets, USP) CIII Now Available
MAPLE GROVE, Minn., July 27, 2015 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. (Upsher-Smith) announced that it has received U.S. Food and Drug Administration (FDA) approval of a supplemental abbreviated new drug application (sANDA) and request for an alternate active pharmaceutical...
ANI Pharmaceuticals and Sofgen Announce FDA Approval of Nimodipine 30mg Capsules
BAUDETTE, Minn., July 27, 2015 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP) today announced that its ANDA collaboration partner Sofgen has received approval from the U.S. Food and Drug Administration (FDA) of the Abbreviated New Drug Application (ANDA) for...
FDA approves a new ultrasound imaging agent
The U.S. Food and Drug Administration today approved Lumason (sulfur hexafluoride lipid microsphere) for patients whose ultrasound image of the heart (echocardiograms) are hard to see with ultrasound waves.
FDA approves first combination pill to treat hepatitis C
The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.
FDA approves first drug-coated angioplasty balloon catheter to treat vascular disease
The U.S. Food and Drug Administration today approved the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB). This is the first drug-coated balloon used to re-open arteries in the thigh (superficial femoral arteries) and knee (popliteal arteries) when narrowed or blocked as a result of peripheral artery disease (PAD).
FDA approves Akynzeo for nausea and vomiting associated with cancer chemotherapy
The U.S. Food and Drug Administration today approved Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy.
FDA seeks permanent injunction against Pharmaceutical Innovations, Inc.
The U.S. Food and Drug Administration is seeking a permanent injunction to stop Pharmaceutical Innovations Inc., and its principal officer, Gilbert Buchalter, from manufacturing, marketing, selling, and distributing medical products until they come into compliance with all applicable FDA requirements.
The FDA takes steps to strengthen cybersecurity of medical devices
To strengthen the safety of medical devices, the U.S. Food and Drug Administration today finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information.
FDA awards grants to stimulate drug, device development for rare diseases
The U.S. Food and Drug Administration today announced it has awarded 15 grants totaling more than $19 million to boost the development of medical device, drug, and biological products for patients with rare diseases, with at least a quarter of the funding going to studies focused solely on pediatrics.
U.S. Marshals seize botanical substance kratom from southern California facility
U.S. Marshals at the request of the U.S. Food and Drug Administration today seized more than 25,000 pounds of raw kratom material worth more than $5 million from Rosefield Management, Inc. in Van Nuys, California.
NIH and FDA win top award for intellectual property licensing of meningitis vaccine
The National Institutes of Health and the U.S. Food and Drug Administration will receive a top national award for the year’s most outstanding intellectual property licensing deal, for technology transfer of a pioneering, low-cost meningitis vaccine launched in sub-Saharan Africa. The 2014 Deals of Distinction Award will be presented to the two federal agencies and their collaborators by the Licensing Executives Society at the society’s 50th annual meeting, Oct. 5-8 in San Francisco.
FDA clears glucose monitoring system for use in hospital critical care units
Today the U.S. Food and Drug Administration cleared a new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized. This is the first blood glucose monitoring system (BGMS) cleared by FDA for use in these patients.
FDA food safety challenge to spur new technologies for fighting foodborne illness
The U.S. Food and Drug Administration is asking for potential breakthrough ideas on how to find disease-causing organisms in food – especially Salmonella in fresh produce.
FDA allows marketing of the first test to identify five yeast pathogens directly from a blood sample
The U.S. Food and Drug Administration today allowed marketing in the U.S. of the first direct blood test for detection of five yeast pathogens that cause bloodstream infections: Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata and/or Candida krusei.
FDA releases updated proposals to improve food safety and help prevent foodborne illness in response to public comments
Based on extensive outreach and public comment, the U.S. Food and Drug Administration today proposed revisions to four proposed rules designed to help prevent food-borne illness. When finalized, the proposed rules will implement portions of the FDA Food Safety Modernization Act (FSMA), which aims to strengthen food safety by shifting the focus to preventing food safety problems rather than responding to problems after the fact.
FDA approves Trulicity to treat type 2 diabetes
The U.S. Food and Drug Administration today approved Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.
FDA approves Movantik for opioid-induced constipation
The U.S. Food and Drug Administration today approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.
FDA approves weight-management drug Contrave
The U.S. Food and Drug Administration today approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.
FDA reminds health care professionals and consumers not to use sterile products from Downing Labs/NuVision Pharmacy of Texas
The U.S. Food and Drug Administration is reminding health care professionals and consumers about safety concerns with all sterile-use drug products made and distributed by Downing Labs LLC, doing business as NuVision Pharmacy, in Dallas, Texas. Health care professionals should not use any NuVision/Downing Labs sterile products for their patients because the firm cannot ensure the safety or quality of these products. Administration of a non-sterile drug product may result in serious and potentially life-threatening infection or death.
FDA allows marketing of the first test to assess risk of developing acute kidney injury
Today the U.S. Food and Drug Administration allowed marketing of the NephroCheck test, a first-of-a-kind laboratory test to help determine if certain critically ill hospitalized patients are at risk of developing moderate to severe acute kidney injury (AKI) in the 12 hours following the administration of the test. Early knowledge that a patient is likely to develop AKI may prompt closer patient monitoring and help prevent permanent kidney damage or death.
U.S. Marshals seize drug products from Flawless Beauty
Various unapproved and improperly labeled drug products that were marketed, sold and distributed via the Internet by Flawless Beauty LLC, of Asbury Park, New Jersey, have been seized by U.S. Marshals at the request of the U.S. Food and Drug Administration and the U.S. Attorney for the District of New Jersey. These products, including injectable drug products, were marketed, sold and distributed to individuals, retail outlets, health spas and clinics.
FDA approves Keytruda for advanced melanoma
The U.S. Food and Drug Administration today granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.