Biotechnology company Avaxia Biologics has received AVX-470 investigational new drug (IND) application clearance for the treatment of ulcerative colitis from the FDA. The bovine anti-tumor necrosis factor polyclonal antibody is based on ...
Tags: Avaxia, Ulcerative Colitis Therapy, IND
The European Commission (EC) has granted a €6m grant to the "FIGHT HLH" consortium of institutions to support clinical testing of NovImmune's anti-interferon gamma drug candidate, NI-0501. The FIGHT HLH consortium lead by NovImmune ...
Janssen Biotech, a Johnson & Johnson company, has executed a license and development agreement for an investigational anti-cancer agent, daratumumab (HuMax-CD38), with Genmab. Daratumumab is a human CD38 monoclonal antibody which is ...
Tags: Daratumumab License, license and development agreement, anti-cancer
Pulmatrix has demonstrated iSPERSE capabilities for inhaled dry powder delivery of antibiotics, antibodies and other macromolecules. These preclinical data demonstrated the ability of iSPERSE formulations to deliver stable and ...
Ipsen has avoided an interruption in US supply of Increlex (IGF-1) to treat Severe Primary IGF-1 Deficiency due to delays in manufacturing site approval. Ipsen has worked in close relation with the US Food and Drug Administration to ...
Tags: Ipsen, Increlex Supply, Severe Primary IGF-1 Deficiency
The US FDA has accepted ThromboGenics'biologics license application for ocriplasmin intravitreal injection,2.5mg/ml and granted it priority review. The company proposed the injection for the treatment of symptomatic Vitreomacular ...
Synthetic Biologics has enterd into second worldwide exclusive channel collaboration with Intrexon to address unmet medical needs of infectious diseases. Synthetic Biologics leverages Intrexon's suite of proprietary technologies for the ...
Tags: Synthetic Biologics, infectious diseases, medical needs
Medtronic has obtained CE mark approval for its Shilla Growth Guidance system to provide new option for children with life-threatening curvature of spine. The Shilla system is designed to correct multi-planar spinal deformities associated ...
Tags: Medtronic, Shilla Growth Guidance system, curvature of spine
Orthofix International has launched a new spinal spacer system, designed to improve surgical efficiency during posterior lumbar interbody fusion and transforaminal lumbar interbody fusion procedures. The new system, FORZA, features ...
Tags: Orthofix, spinal spacer system, FORZA
RTI Biologics has introduced a new ready-to-use demineralized bone matrix (DBM) implant for use in sports medicine, orthopedic and spine surgeries. The new biologic implant, BioReady DBM Putty and Putty with Chips, is a 100% allograft ...
Bruker has launched a new software solution, BioPharmaCompass 1.1 to encompass the complete biopharmaceutical characterization challenge, which includes glycoforms, impurities and modifications. The software allows biotech customers to ...
Tags: software solution, biopharmaceutical characterization, mass spectrometry
Biomet, a distributor of musculoskeletal medical products, has entered into an agreement to distribute Bonesupport's proprietary Cerament|Bone void Filler product line, designed for orthopedics, trauma and foot and ankle indications. ...
Tags: musculoskeletal medical products, Bonesupport Void Filler Products
Genzyme, a Sanofi company, has received a refuse to file letter from the US Food and Drug Administration (FDA) in response to the supplemental Biologics License Application (sBLA) for the approval of Lemtrada (alemtuzumab) as a treatment ...
Tags: Genzyme, Lemtrada marketing, FDA
NSF International, which develops standards as well as tests and certifies products , has completed the acquisition of Becker & Associates Consulting. Becker & Associates, a clinical and scientific consulting firm, provides regulatory ...
Tags: certifies products, clinical consulting, scientific consulting
Emergent BioSolutions has received FDA approval for its supplemental Biologics License Application (sBLA) to change the administration schedule of BioThrax to a three-dose primary series of intramuscular injections at zero, one, and six ...
Tags: Medicine, Emergent BioSolutions, Anthrax Vaccine Adsorbed