Pharming Group and Santarus have announced the submission of Ruconest (recombinant human C1 esterase inhibitor) biologics license application to the FDA. Investigational drug Ruconest 50 U/kg is being developed for the treatment of acute ...
India-based Dr. Reddy's Laboratories is planning to relocate North America headquarters and establish R&D Center in Princeton, New Jersey, US. The new North America Headquarters accomodates company's generics, biologics, PSAI and ...
Tags: Dr.Reddy, R&D Center
Why WestHolland? With almost 500 million residents, and a purchasing power second to none, Europe is one of the world's most important business and consumer markets. Dutch know-how and expertise in international trade and commerce make ...
Tags: Service, Business cooperation
US-based privately-held spinal device company K2M has launched new VENADO Foam Strips and VENADO Granules bone graft systems under its US biologics range. VENADO is a new product family in K2M's growing biologics portfolio, which already ...
Tags: Bone Graft Systems, Health, Medicine
US-based contract research organization (CRO) Pharmaceutical Product Development (PPD) is expanding its cGMP cell-based assay laboratory in Middleton, Wisconsin, US. The cell lab facility has been added with an approximate 6,800ft2 space, ...
US-based pharmaceutical company Zogenix has extended its co-marketing partnership with Battelle, for the DosePro needle-free drug delivery system through 29 March 2014. The partnership is focused on advancing out-licensing opportunities ...
The US FDA has accepted Merck's biologics license application (BLA) for an investigational allergy immunotherapy tablet (AIT), Timothy grass pollen (Phleum pratense). The application includes safety and efficacy data of the ...
Tags: FDA, Merck Bla, Allergy Immunotherapy Tablet
AstraZeneca is set to establish a global research and development (R&D) center at Gaithersburg, Maryland to improve pipeline productivity. These changes are made in order to simplify the company's global site footprint and to invest in ...
Tags: AstraZeneca, R&D center, research and development center
Sonoco ThermoSafe, a unit of Sonoco, has announced the launch of the new Certis Silver Universal CRT (controlled room temperature) shipper series to protect pharmaceuticals, biologics, vaccines and other high-value products. The new ...
Sonoco ThermoSafe, a provider of temperature assurance packaging, has introduced new Certis Silver Universal controlled room temperature (CRT) design-qualified shippers. Certis CRT design-qualified shippers ensure ambient thermal ...
Tags: Sonoco, pharmaceuticals, value products
The US Food and Drug Administration (FDA) has granted 510(k) clearance to RTI Biologics' porcine dermis implant for use in soft tissue repair procedures such as hernia repair. The implant is comprised of non-crosslinked porcine dermis and ...
Tags: FDA, biologics portfolio, RTI Biologics
Biogen Idec is seeking marketing approval from the US Food and Drug Administration (FDA) for recombinant factor VIII Fc fusion protein (rFVIIIFc) therapy to treat hemophilia A. The company has submitted a biologics license application ...
Tags: Biogen Idec, FDA, hemophilia A
OsteoMed, a developer of small bone implants and biologics, has launched OsteoVation QWIK to fill bony voids and gaps of the skeletal system. Comprised of a proprietary composite of calcium phosphate and calcium sulfate granules, ...
Tags: OsteoMed, OsteoVation QWIK, bony voids
The US Food and Drug Administration (FDA) has accepted Biogen Idec's biologics license application (BLA) for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B. Using the company's ...
Tags: FDA, Idec BLA, hemophilia B
Baxter has submitted a biologics license application (BLA) supplement to the US Food and Drug Administration (FDA) for the approval of its prophylaxis treatment of FEIBA NF [Anti-Inhibitor Coagulant Complex], Nanofiltered and Vapor Heated, ...
Tags: Baxter, Feiba NF Drug, Medicine