Biogen has announced acceptance of marketing applications of Plegridy(peginterferon beta-1a) for review by the US and EU regulatory authorities. Plegridy, a member of the interferon class of treatments, is a pegylated subcutaneous ...
Tags: Biogen, Marketing Applications
La Jolla Pharmaceutical Company has reported a comprehensive net loss attributable to common stockholders of $3.74m, or $0.14 per share, for the second quarter ended on 30 June 2013 compared with $7.77m, or $0.67 per share in 2012. ...
Tags: La Jolla Pharmaceutical, Net Loss
Biopharmaceutical development company Chelsea Therapeutics has announced the US FDA acceptance of Northera (droxidopa) new drug application (NDA) resubmission to treat symptomatic neurogenic orthostatic hypotension (NOH). The company is ...
US-based Aquavit Pharmaceuticals has inked a definitive licensing agreement with U-Bio Med, a South Korea-based medical technology device firm, for the global commercialization of its microneedle device technology. The agreement offers ...
Tags: Aquavit Inks, U-Bio Med, Microneedle Device Technology
The Institute of Food Technologists (IFT) Board of Directors approved the launch of a new food traceability center designed to protect and improve the global food supply. The Global Food Traceability Center will serve as an authoritative, ...
Tags: Food Traceability Center, Food
Fiber-based packaging supplier Evergreen Packaging has entered into an intellectual property license agreement with Smart Planet Technologies to explore the development of cupstock products using EarthCoating technology. EarthCoating ...
Clinical-stage pharmaceutical company Adynxx has obtained the US Food and Drug Administration (FDA) fast track designation for its AYX1 injection, which is used for prevention of chronic pain. In a five-cohort, dose-escalating study ...
The US FDA has approved Janssen Biotech's Simponi ARIA (golimumab) for infusion to treat moderately to severely active rheumatoid arthritis (RA). Simponi ARIA is the only fully-human anti-tumor necrosis factor (TNF)-alpha infusible ...
The US Food and Drug Administration (FDA) has banned the imports of salmon produced in Chile by Norwegian multinational firm Marine Harvest after a carcinogenic chemical known as crystal violet was detected in a shipment. Crystal violet ...
Tags: Salmon, carcinogenic chemical
US regulatory authorities have allowed the marketing of a brain wave test, which can diagnose attention-deficit/hyperactivity disorder (ADHD) in children and adolescents aged between six and 17 years. This device, called Neuropsychiatric ...
Specialty pharmaceutical company Iroko Pharmaceuticals has announced the FDA acceptance for New Drug Application (NDA) filing of lower dose submicron Indomethacin, a non-steroidal anti-inflammatory drug. The proposed indication of the ...
Tags: FDA Acceptance, NDA Filing
Hagee Foods, dba Penny's Salsa, is recalling hummus products in the US as they may be contaminated Listeria monocytogenes. The retail hummus products come in 8 oz. and 12 oz. clear plastic packages and were distributed to retail stores ...
Tags: Hagee Foods, Hummus Products, Health Risk
Mylan Pharmaceuticals has introduced Norethindrone Tablets USP, 0.35mg, which is the generic version of Watson Laboratories' (now Actavis) Nor-Q.D. tablets, 0.35mg for 28-day cycle, for the prevention of pregnancy in the US. The ...
Tags: Generic Contraceptive Pill, Mylan
SynGen has received 510(k) approval from the US Food and Drug Administration (FDA) to market its SynGenX-1000 System, CryoPRO-2 Cryopreservation/Storage Bag Set, SynGen DataTrak software products to process cord blood. Previously, the ...
Tags: Cord Blood Processing, Syngen
The US Food and Drug Administration (FDA) has issued a Class I recall of Medtronic’s MiniMed Paradigm Insulin Infusion Sets. The Paradigm infusion sets are meant for use with Paradigm insulin infusion pumps. These infusion sets are ...