SENOMYX ANNOUNCES RECEIPT OF GENERALLY RECOGNIZED AS SAFE (GRAS) DETERMINATION FOR NEW SWEETMYX™ FLAVOR INGREDIENT
SAN DIEGO, March 11, 2014 /PRNewswire/ -- Senomyx, Inc. (NASDAQ: SNMX), a leading company using proprietary taste science technologies to discover, develop and commercialize novel flavor ingredients for the food, beverage and flavor industries, announced today that its new Sweetmyx...
Trojan Marinex™ BWT-System erhält IMO-Typengenehmigung nach US-Teststandards
LONDON, Ontario, March 11, 2014 /PRNewswire/ --
Trojan Technologies gab heute bekannt, dass die Produktsuite zur Ballastwasseraufbereitung (Ballast Water Treatment, BWT) von Trojan Marinex im Auftrag des norwegischen Seefahrtsdirektorats eine Typengenehmigung nach den Maßstäben...
El sistema Trojan Marinex™ BWT se asegura la aprobación de tipo IMO usando los estándares de pruebas de Estados Unidos
LONDRES, Ontario, March 11, 2014 /PRNewswire/ --
Trojan Technologies anunció hoy que la gama de productos Trojan Marinex Ballast Water Treatment (BWT) ha conseguido la aprobación del tipo International Maritime Organization (IMO) de Det Norske Veritas (DNV) en nombre del...
Fortschritte bei ESTEVE und U.A.B. im Programm zur Entwicklung eines Heilmittels für Sanfilippo-A-Syndrom
BARCELONA, Spanien, March 11, 2014 /PRNewswire/ --
Dieses Gentherapie-Programm wird im Rahmen einer öffentlich-privaten Partnerschaft zwischen ESTEVE und dem Forschungsteam von Dr. Fàtima Bosch am Center for Biotechnology and Gene Therapy der Universitat Autònoma de...
ESTEVE et U.A.B. font progresser leur programme d'élaboration d'un traitement du syndrome de Sanfilippo de type A
BARCELONA, Espagne, March 11, 2014 /PRNewswire/ --
Ce programme de thérapie génique est mené dans le cadre d'un partenariat public-privé conclu entre ESTEVE et l'équipe de recherche du Dr Fàtima Bosch au Centre de biotechnologie et de thérapie...
ESTEVE and U.A.B. Advance in Their Program to Develop a Cure for Sanfilippo A Syndrome
BARCELONA, Spain, March 11, 2014 /PRNewswire/ --
This gene therapy program is being developed in a public-private partnership between ESTEVE and the research team of Dr. Fàtima Bosch at the Center for Biotechnology and Gene Therapy of the Universitat Autònoma de Barcelona...
ESTEVE y la UAB impulsan el desarrollo de un tratamiento para el síndrome de Sanfilippo A
BARCELONA, España, March 11, 2014 /PRNewswire/ --
La investigación de esta nueva terapia génica se enmarca dentro del partenariado público-privado entre la farmacéutica y el grupo que dirige la Dra. Fàtima Bosch en el CBATEG de la UAB
Le système BWT de Trojan Marinex™ obtient une homologation de l'OMI en utilisant les normes de test des États-Unis
LONDON, Ontario, March 11, 2014 /PRNewswire/ --
Trojan Technologies a annoncé aujourd'hui que la gamme de produits Trojan Marinex de traitement des eaux de ballast (BWT) a obtenu de Det Norske Veritas (DNV), au nom de la Direction maritime norvégienne, l'homologation de...
FDA Designates Regado's REG1 in PCI as a Fast Track Development Program
BASKING RIDGE, N.J., March 10, 2014 /PRNewswire/ -- Regado Biosciences, Inc. (Nasdaq: RGDO), a biopharmaceutical company focused on the development of actively controllable therapeutics, today announced that the United States Food and Drug Administration (FDA) has designated REG1 for...
Frost & Sullivan: Tiered Strategy Will Help Pump Manufacturers Gain Ground as New FDA Food Safety Regulation (FSMA) Strengthens Demand
MOUNTAIN VIEW, Calif., March 6, 2014 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA)'s efforts to constantly improve regulations regarding sanitation and public safety have widened the scope of the pumps market in the U.S. The implementation of the Food Safety Modernization...
MedNet Solutions Welcomes Oncotherapeutics To The iMedNet Partner Program
MINNETONKA, Minn., March 6, 2014 /PRNewswire/ -- MedNet Solutions, a global life sciences technology company specializing in clinical study management systems, is pleased to announce that Oncotherapeutics, a full service CRO with a unique focus on therapeutic oncology, is the...
Oramed to Present at Upcoming Conferences
JERUSALEM, March 6, 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, announced today the Company will present at the following conferences in March...
Maxwell Biotech Venture Fund's Portfolio Company Hepatera Completes Enrollment of Phase IIa clinical trial of Myrcludex B, for HBV
MOSCOW, March 6, 2014 /PRNewswire/ --
A group of 48 patients infected with the hepatitis B virus (HBV) have been enrolled in the phase IIa clinical trial of Myrcludex B by Russian biotech company Hepatera Ltd. Hepatera is financed by Maxwell Biotech Venture Fund, set up with...
U.S. FDA Approves AVEED™ (Testosterone Undecanoate) Injectable Testosterone Replacement Therapy For Men Living With Hypogonadism, Or Low-T
DUBLIN, March 6, 2014 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) (TSX: ENL) announced today that its operating company Endo Pharmaceuticals Inc. received U.S. Food and Drug Administration (FDA) approval of AVEED™ (testosterone undecanoate) injection for the...
In New Poll Americans Weigh In On Best Options For FDA Updates To Nutrition Label
WASHINGTON, March 5, 2014 /PRNewswire-iReach/ -- Last week the FDA unveiled proposed changes to the 20-year-old nutrition label on food packaging. Changes include increased focus on calories, added sugar critical vitamins and minerals, recalibration of the daily-recommended value of...
U.S. Food and Drug Administration Issues Complete Response Letter for Empagliflozin
RIDGEFIELD, Conn. and INDIANAPOLIS, March 5, 2014 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (Lilly; NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the New Drug...
MedShape Introduces New Porous PEEK Suture Anchor
ATLANTA, March 5, 2014 /PRNewswire/ -- MedShape, Inc., today announced the company received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Morphix® SP Suture Anchor. The device features the company's new Scoria™ technology, a polyetheretherketone (PEEK)...
Bioniche Life Sciences Inc. Announces Key Corporate Updates
BELLEVILLE, ON, March 4, 2014 /PRNewswire/ - Bioniche Life Sciences Inc. (TSX:
BNC) announced today key corporate updates:
The establishment of Monday, April 14, 2014 as the date of the Shareholder Meeting for consideration of the C$61
million acquisition offer for Bioniche's Animal...
Preparing Products for New FDA Food and Beverage Labeling Laws
NEW YORK, March 4, 2014 /PRNewswire/ -- Selerant (www.selerant.com) provides clear steps to prepare food and beverage products for the FDA's proposed food labeling laws: http://blog.selerant.com/selerant-blog/how-will-the-new-labeling-rules-affect-you.
"The FDA's proposed...
D-Pharm Reports the Successful Interim Analysis of its Phase 2 Clinical Study of THR-18 in Acute Stroke Patients Treated With the Thrombolytic Drug tPA
REHOVOT, Israel, March 4, 2014 /PRNewswire/ --
D-Pharm Ltd (TASE: DPRM) announced today, March 4th, 2014, the successful interim analysis of the first group of stroke patients that completed follow-up in the Phase 2 clinical study of THR-18. The interim report confirms the safety and...
First Response™ Reaches Another Milestone with Enhanced Pregnancy Test Technology
EWING, N.J., March 4, 2014 /PRNewswire/ -- Church & Dwight Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) has cleared the First Response™ Gold™ Digital Pregnancy Test to determine if a woman is pregnant up to six (6) days before her missed...
AAA Receives Orphan Drug Designation from FDA and EMA for Gallium-68 DOTATATE for Use in Patients with Gastro-Entero-Pancreatic Neuroendocrine Tumors
SAINT-GENIS-POUILLY, France, March 4, 2014 /PRNewswire/ --
Advanced Accelerator Applications (AAA), a fast growing international player in Molecular Nuclear Medicine (MNM), announced today that they have received orphan drug designation status for their radiopharmaceutical, Gallium-68...
IGI Laboratories, Inc. Announces Fourteenth ANDA Submission
BUENA, N.J., March 3, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted its first abbreviated new drug application (ANDA) in 2014 to the U.S. Food and Drug Administration (FDA),...
Oramed to Present Results from its Phase 2a FDA Trial with ORMD-0801 at the 2014 Diabetes Summit on April 24, 2014
JERUSALEM, March 3, 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, announced today that it will be presenting detailed results from its recently...
InterMune® annonce son soutien à la création de la première Charte européenne des patients atteints de fibrose pulmonaire idiopathique (FPI)
MUTTENZ, Suisse, February 28, 2014 /PRNewswire/ --
A l'occasion de la Journée internationale des maladies rares, InterMune annonce son soutien au développement d'une Charte européenne des patients atteints de fibrose pulmonaire idiopathique (FPI).
Ellman International Enters Body Treatment Market
HICKSVILLE, N.Y., Feb. 27, 2014 /PRNewswire/ -- Ellman International, Inc., a global leader in advanced radiofrequency (RF) and laser technology for precision surgical and aesthetic procedures, announced today that the company has received clearance from US Food and Drug...
BioElectronics Researchers And Clinicians Support FDA's Position To Reclassify Shortwave Medical Devices To Class II
FREDERICK, Md., Feb. 27, 2014 /PRNewswire/ -- Medical device researchers and clinicians are optimistically supportive of the Food and Drug Administration's decision last week to reclassify and rename electronic shortwave diathermy for many other uses, a decision that may improve...
FDA proposes updates to Nutrition Facts label on food packages
The U.S. Food and Drug Administration today proposed to update the Nutrition Facts label for packaged foods to reflect the latest scientific information, including the link between diet and chronic diseases such as obesity and heart disease. The proposed label also would replace out-of-date serving sizes to better align with how much people really eat, and it would feature a fresh design to highlight key parts of the label such as calories and serving sizes.
FDA Grants Astellas Qualified Infectious Disease Product Designation for Isavuconazole for the Treatment of Invasive Mucormycosis
NORTHBROOK, Ill., Feb. 27, 2014 /PRNewswire/ -- Astellas Pharma Global Development, Inc., a subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced today that the U.S. Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product...
FDA approves Myalept to treat rare metabolic disease
The U.S. Food and Drug Administration today approved Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy.
FDA issues first orders to stop sale, distribution of tobacco products
The U.S. Food and Drug Administration issued orders today to stop the further sale and distribution of four tobacco products currently on the market. The action marks the first time the FDA has used its authority under the Family Smoking Prevention and Tobacco Control Act to order a manufacturer of currently available tobacco products to stop selling and distributing them.
FDA and European Medicines Agency strengthen collaboration in pharmacovigilance area
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have set-up a new 'cluster' on pharmacovigilance (medicine safety) topics. Clusters are regular collaborative meetings between the EMA and regulators outside of the European Union, which focus on specific topic areas that have been identified as requiring an intensified exchange of information and collaboration. Building on the experience of previous regular videoconferences between the FDA and the EMA in this area and on the recent creation of the EMA’s Pharmacovigilance Risk Assessment Committee, this cluster will provide a forum for a more systematic and focused exchange of information on the safety of medicines.
FDA approves Northera to treat neurogenic orthostatic hypotension
The U.S. Food and Drug Administration today approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension (NOH). NOH is a rare, chronic and often debilitating drop in blood pressure upon standing that is associated with Parkinson's disease, multiple-system atrophy, and pure autonomic failure.
FDA initiates the Secure Supply Chain Pilot Program to enhance security of imported drugs
The U.S. Food and Drug Administration is announcing the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs. In August 2013, the FDA published a notice in the Federal Register (78 FR 51192) to solicit companies to voluntarily submit applications for participation in this two-year program. Thirteen prequalified companies have now been designated to take part, and will receive expedited entry for the importation of up to five selected drug products into the United States.
FDA approves Vimizim to treat rare congenital enzyme disorder
The U.S. Food and Drug Administration today approved Vimizim (elosulfase alfa), the first FDA approved treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome). Morquio A syndrome is a rare, autosomal recessive lysosomal storage disease caused by a deficiency in N-acetylgalactosamine-6-sulfate sulfatase (GALNS). Vimizim is intended to replace the missing GALNS enzyme involved in an important metabolic pathway. Absence of this enzyme leads to problems with bone development, growth and mobility. There are approximately 800 patients with Morquio A syndrome in the United States.
Science Financier Jeffrey Epstein Heralds FDA's Approval of Inhibitor Cocktails for Melanoma
NEW YORK, Feb. 14, 2014 /PRNewswire/ -- The well-known science philanthropist and founder of the Program for Evolutionary Dynamics at Harvard University, has heralded the Food and Drug Administration's approval of the first inhibitor combination clinical trial for melanoma...
Shire Announces FDA Approval of Manufacturing Facility for VPRIV® (Velaglucerase Alfa for Injection) Drug Substance
LEXINGTON, Massachusetts, February 14, 2014 /PRNewswire/ --
Shire plc (LSE: SHP, NASDAQ: SHPG), the global specialty biopharmaceutical company, announced today that the US Food & Drug Administration (FDA) has approved the production of VPRIV® drug substance (velaglucerase alfa...
IMRIS receives FDA clearance for next generation VISIUS Surgical Theatre
Most advanced Siemens MR scanners provide highest intraoperative image
quality and best workflow available
MINNEAPOLIS, Feb. 13, 2014 /PRNewswire/ - IMRIS Inc. (NASDAQ: IMRS; TSX: IM)
("IMRIS" or the "Company") today announced US Food and Drug
Administration clearance of the newest...
Illegal prescription drug sellers arraigned on charges for smuggling illicit cancer drugs into the United States
Two individuals today were arraigned for charges that they, among other things, smuggled adulterated and misbranded prescription cancer treatments from Turkey and other countries into the United States and conspired to defraud the United States and the U.S. Food and Drug Administration. The drugs did not meet the FDA’s standards and had not been approved for distribution in the United States.
JustRight Surgical® wins FDA clearance for first ever 5mm classic surgical stapler
BOULDER, Colo., Feb. 13, 2014 /PRNewswire/ -- JustRight Surgical, a micro-laparoscopic medical device company devoted to miniaturizing surgical instrumentation, has received 510 (k) clearance from the U.S. Food and Drug Administration (FDA) for its JustRight™ 5mm Stapler. The...
FDA approves Imbruvica to treat chronic lymphocytic leukemia
The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.
FDA warns against using Uncle Ben's Infused Rice
The FDA, the Centers for Disease Control and Prevention (CDC), and state and local officials have been investigating a cluster of illnesses associated with Uncle Ben’s Infused Rice Mexican Flavor sold in 5- and 25-pound bags.
Updated FDA requirements for infant formula will maintain high-quality standards and help ensure healthy growth of infants
Today, the U.S. Food and Drug Administration published an interim final rule to further safeguard the health of infants fed infant formula in the United States. The rule, which sets standards for manufacturers to produce safe infant formula that supports healthy growth, is accompanied by two draft guidance documents for industry.
FDA Commissioner Hamburg travels to India
Today, the U.S. Food and Drug Administration announced that Commissioner Margaret A. Hamburg, M.D. will travel February 10-18 to India to further strengthen cooperation between the FDA and its Indian regulatory counterparts.
FDA launches its first national public education campaign to prevent, reduce youth tobacco use
The U.S. Food and Drug Administration today announced the launch of a national public education campaign to prevent youth tobacco use and reduce the number of kids ages 12 to 17 who become regular smokers. 'The Real Cost' campaign is the FDA's first of several planned tobacco education campaigns using the new authority granted under the Family Smoking Prevention and Tobacco Control Act, signed into law by President Obama in 2009.
FDA approves pediatric use of Dexcom's G4 Platinum continuous glucose monitoring system
The U.S. Food and Drug Administration today approved the expanded use of the Dexcom G4 Platinum Continuous Monitoring System for patients with diabetes ages 2 to 17 years. The G4 Platinum System, which monitors blood glucose levels in people with diabetes, had been approved for patients ages 18 and older.
FDA Approves Hetlioz: first treatment for non-24 hour sleep-wake disorder in blind individuals
The U.S. Food and Drug Administration today approved Hetlioz (tasimelteon), a melatonin receptor agonist, to treat non-24- hour sleep-wake disorder (“non-24”) in totally blind individuals. Non-24 is a chronic circadian rhythm (body clock) disorder in the blind that causes problems with the timing of sleep. This is the first FDA approval of a treatment for the disorder.
FDA proposes rule to prevent food safety risks during transportation
The U.S. Food and Drug Administration today proposed a rule that would require certain shippers, receivers, and carriers who transport food by motor or rail vehicles to take steps to prevent the contamination of human and animal food during transportation.
FDA Statement on Western Sugar Cooperative voluntary recall of beet pulp and tailings
he U.S. Food and Drug Administration, in close coordination with the Wyoming Department of Agriculture (WDA) and the U.S. Department of Agriculture (USDA), has been working to address a tragic accident that occurred at the Western Sugar Cooperative’s Lovell, Wyo., manufacturing facility on Jan. 4, 2014.
FDA prohibits Ranbaxy's Toansa, India facility from producing and distributing drugs for the U.S. market
The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. The Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012.