Harvoni® (ledipasvir/sofosbuvir) approved for the treatment of chronic hepatitis C, genotype 1 infection in adults; Diplomat to distribute
FLINT, Mich., Oct. 22, 2014 /PRNewswire/ -- U.S. Food and Drug Administration (FDA) announced October 10, 2014 that Gilead Sciences Harvoni® (ledipasvir/sofosbuvir) product was approved for the treatment of chronic hepatitis C, genotype 1 infection in adults. Harvoni® is the...
Unisense FertiliTech A/S erhält FDA-Zulassung für Embryoselektions-Tool zur Verbesserung der IVF-Behandlung
AARHUS, Dänemark, October 22, 2014 /PRNewswire/ --
Passgenaue Tools zur Beurteilung von Embryonen in der IVF-Praxis sind ab sofort für den klinischen Einsatz in den USA erhältlich
Unisense FertiliTech A/S, der weltweit führende Anbieter von...
Unisense FertiliTech A/S recibe aprobación de la FDA como herramienta para ayudar a la selección embrionaria
AARHUS, Dinamarca, October 22, 2014 /PRNewswire/ --
- Unisense FertiliTech A/S recibe la aprobación de la FDA como herramienta para ayudar a la selección embrionaria y así mejorar el tratamiento de IVF
Las herramientas de evaluación...
Unisense FertiliTech A/S : l'outil de sélection des embryons pour améliorer le traitement de FIV reçoit l'agrément de la FDA
AARHUS, Danemark, October 22, 2014 /PRNewswire/ --
L'utilisation clinique d'outils d'évaluation de la qualité embryonnaire personnalisés pour la pratique de la fécondation in vitro (FIV) est désormais possible aux États-Unis
MedNet Solutions To Host Third Annual iMedNet User Group Meeting
MINNETONKA, Minn., Oct. 22, 2014 /PRNewswire/ -- MedNet Solutions, a global life sciences technology company specializing in clinical study management systems, is pleased to announce the 2014 iMedNet User Group Meeting. This year's two-day event – to be held in...
BioLight to Present at the Canaccord Genuity 2014 Medical Technology and Diagnostics Forum
TEL AVIV, Israel, October 22, 2014 /PRNewswire/ --
BioLight Life Sciences Investments Ltd. (TASE: BOLT, OTCQX:BLGTY), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, announced today that Suzana...
Oramed Pharmaceuticals Reports Positive Top-Line Data from U.S. Phase IIa Trial with Oral Insulin in Type 1 Diabetes
JERUSALEM, October 22, 2014 /PRNewswire/ --
Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (http://www.oramed.com ), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, today reported positive top-line clinical results from its Phase IIa...
Expanding Orthopedics Inc. Granted a New US patent - Adding to its Extensive IP Portfolio of Expandable Bone Devices
OR AKIVA, Israel, October 22, 2014 /PRNewswire/ --
Expanding Orthopedics Inc. (EOI), a privately held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, is excited to announce that it has been granted its 13th US patent,...
Demostradas la eficacia y la seguridad a largo plazo de la monoterapia con Zonegran® (zonisamida) una vez al día en la extensión de un estudio fundamental
HATFIELD, Reino Unido, October 22, 2014 /PRNewswire/ --
COMUNICADO DE PRENSA SOLO PARA MEDIOS DE LA UE: NO PARA LOS MEDIOS SUIZOS/ESTADOUNIDENSES
Zonegran® (zonisamida) continúa presentando buena tolerabilidad y eficacia cuando se utiliza como monoterapia a largo plazo...
Studio di estensione in aperto conferma la sicurezza e l'efficacia a lungo termine di Zonegran® (zonisamide) come monoterapia in monosomministrazione giornaliera
HATFIELD, Regno Unito, October 22, 2014 /PRNewswire/ --
COMUNICATO STAMPA DESTINATO ESCLUSIVAMENTE AI MEDIA DELL'UE: NON DESTINATO AI GIORNALISTI DI SVIZZERA/STATI UNITI
Una nuova pubblicazione su Epilepsia ha confermato la tollerabilità e l'efficacia di Zonegran®...
Zonegran® (zonisamide) en monotherapie: securite d’emploi et efficacite confirmees en administration unique quotidienne
HATFIELD, Royaume-Uni, October 22, 2014 /PRNewswire/ --
COMMUNIQUÉ DE PRESSE DESTINÉ AUX MÉDIAS EUROPÉENS UNIQUEMENT : NE CONCERNE PAS LES JOURNALISTES SUISSES/AMÉRICAINS
Zonegran® (zonisamide): un nouvel article publié dans...
Offene Verlängerung der Zulassungsstudie zeigt Langzeitsicherheit und Wirksamkeit der Monotherapie mit einmal täglich einzunehmendem Zonegran® (Zonisamid)
HATFIELD, Großbritannien, October 22, 2014 /PRNewswire/ --
Zonegran® (Zonisamid) ist auch in der Langzeit-Monotherapie für die Behandlung fokaler epileptischer Anfälle bei Erwachsenen mit neu diagnostizierter Epilepsie gut verträglich und wirksam, wie eine neue...
Boston Scientific Receives FDA And CE Mark Approval For New CoverEdge™ Surgical Leads For The Precision Spectra™ Spinal Cord Stimulator (SCS) System
MARLBOROUGH, Mass., Oct. 21, 2014 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) and CE Mark approval for the CoverEdge™ 32 and CoverEdge™ X 32 Surgical Leads, the world's first 32-contact surgical leads...
U.S. Food and Drug Administration accepts filing of new drug application for empagliflozin/metformin fixed-dose combination
RIDGEFIELD, Conn. and INDIANAPOLIS, Oct. 21, 2014 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for empagliflozin plus immediate-release metformin hydrochloride fixed-dose combination, an investigational compound being...
BioSpecifics Technologies Corp. Announces FDA Approval of sBLA for XIAFLEX® for the Concurrent Treatment of Two Dupuytren's Contracture Cords
LYNBROOK, N.Y., Oct. 21, 2014 /PRNewswire/ -- BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® (collagenase clostridium histolyticum or CCH) in the U.S. and XIAPEX® in...
West's Vial2Bag DC Device Receives U.S. FDA 510(k) Clearance and CE Mark
EXTON, Pa., Oct. 21, 2014 /PRNewswire/ -- West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, has received 510(k) clearance of the Vial2Bag® DC device from the United States Food and Drug Administration, and...
First Patient Successfully Implanted in Safety/Efficacy Study of Beta-O2's ßAir Bio-Artificial Pancreas for Type 1 Diabetes
ROSH HAAYIN, Israel, October 21, 2014 /PRNewswire/ --
Beta-O2 announced today that the first patient participating in the company's first broad study of the ßAir Bio-Artificial Pancreas has been successfully implanted. ßAir is in development as a treatment and a...
Auxilium Pharmaceuticals, Inc. Announces XIAFLEX Now Approved For The Concurrent Treatment Of Up To Two Affected Joints In The Same Hand In Dupuytren's Contracture Patients
CHESTERBROOK, Pa., Oct. 20, 2014 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics Application (sBLA) for XIAFLEX® (collagenase...
Novartis announces FDA Advisory Committee unanimously recommends approval of AIN457 (secukinumab) for patients with moderate-to-severe plaque psoriasis
EAST HANOVER, N.J., Oct. 20, 2014 /PRNewswire/ -- Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US Food and Drug Administration (FDA) today voted 7 to 0 to support the approval of AIN457 (secukinumab), a selective interleukin-17A...
OFEV® (nintedanib) Now Available in the United States
RIDGEFIELD, Conn., Oct. 20, 2014 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. has announced that OFEV® (nintedanib) capsules are now commercially available in the United States.
OFEV was approved by the U.S. Food and Drug Administration (FDA) on October 15,...
Halozyme Receives FDA Approval For Additional Manufacturing Facilities For Hylenex® Recombinant
SAN DIEGO, Oct. 20, 2014 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S. Food and Drug Administration (FDA) has approved new contract manufacturing facilities used in the production of Hylenex® recombinant (hyaluronidase human injection)....
IMBRUVICA® (ibrutinib) Supplemental New Drug Application Submitted to the U.S. FDA for Waldenstrom's macroglobulinemia
RARITAN, N.J., Oct. 20, 2014 /PRNewswire/ -- Janssen Research & Development, LLC ("Janssen") today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA® (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its strategic partner...
IonMed Receives CE Mark Clearance for Bioweld1™ Cold Plasma System
YOKNEAM, Israel, October 20, 2014 /PRNewswire/ --
IonMed announced today that it has received CE Mark clearance for its Bioweld1™ cold plasma system for surgical incision closure. Bioweld1 is the first system in the rapidly emerging field of plasma medicine designed for use in...
Taiho Oncology, Inc. Receives FDA Fast Track Designation for TAS-102 as a Potential Treatment for Refractory Metastatic Colorectal Cancer
PRINCETON, N.J., Oct. 20, 2014 /PRNewswire/ -- Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for TAS-102 (nonproprietary names: trifluridine and tipiracil...
Takeda and Orexigen Announce Availability of CONTRAVE® (naltrexone HCI and bupropion HCI) Extended-Release Tablets for Chronic Weight Management in Obese Adults
DEERFIELD, Ill. and OSAKA, Japan, Oct. 20, 2014 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda"), its wholly-owned subsidiary Takeda Pharmaceuticals U.S.A., Inc. and Orexigen® Therapeutics, Inc. (Nasdaq: OREX) jointly announced today that Contrave®...
Pharmacyclics Files Supplemental New Drug Application for IMBRUVICA® for Waldenstrom's Macroglobulinemia
SUNNYVALE, Calif., Oct. 20, 2014 /PRNewswire/ -- Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based on data from a Phase 2 study evaluating the use of IMBRUVICA®...
Pulmonary Fibrosis Foundation Applauds The Food And Drug Administration's (FDA) Prompt Decision To Approve Esbriet® (pirfenidone) And OFEV® (nintedanib) For The Treatment Of Idiopathic Pulmonary Fibrosis
CHICAGO, Oct. 16, 2014 /PRNewswire-USNewswire/ -- The Pulmonary Fibrosis Foundation (PFF) applauds the approval of Esbriet® (pirfenidone) and OFEV® (nintedanib) by the U.S. Food and Drug Administration (FDA) as the first disease-specific therapies for idiopathic pulmonary...
Esbriet® (pirfenidone) receives FDA approval under 'breakthrough status'; Diplomat to distribute
FLINT, Mich., Oct. 16, 2014 /PRNewswire/ -- Diplomat, the nation's largest independent specialty pharmacy, announced today that it has a contract to distribute Esbriet (pirfenidone), which was approved Oct. 15, 2014 by the U.S. Food and Drug Administration for the treatment of...
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.
Syneron annuncia il lancio del dispositivo a picosecondi PicoWay per il trattamento delle lesioni pigmentate e la rimozione dei tatuaggi
WAYLAND, Massachusetts, October 8, 2014 /PRNewswire/ --
Nuovo dispositivo presentato all'EADV (Accademia Europea di Dermatologia e Venereologia)*
Syneron Medical Ltd. (NASDAQ:ELOS), azienda leader a livello mondiale nella produzione di dispositivi per il settore...
Syneron gibt die Markteinführung des PicoWay-Picosekundengeräts bekannt, eines Geräts zur Behandlung von Pigmentläsionen und zur Entfernung von Tattoos
WAYLAND, Massachusetts, October 8, 2014 /PRNewswire/ --
Neues Gerät wurde an der Europäischen Akademie für Dermatologie und Venerologie vorgestellt*
Syneron Medical Ltd. (NASDAQ:ELOS), ein führendes, weltweit tätiges Unternehmen, das Geräte...
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.