Ipsen and Inspiration Biopharmaceuticals have announced FDA Fast Track status to an intravenous recombinant porcine factor VIII, OBI-1, for acquired hemophilia A therapy. The drug candidate is being studied to treat acquired hemophilia A ...
Tags: FDA, fast track status, drug candidate
Janssen Biotech and Janssen Biologics are seeking approval for Stelara in the US and Europe for the treatment of active psoriatic arthritis. A supplemental biologics license application (sBLA) was submitted to the FDA and a Type II ...
The US Food and Drug Administration(FDA)has approved Ethicon Biosurgery's new fibrin sealant patch to aid surgeons in stopping problematic bleeding during surgery. The fibrin sealant patch,EVARREST,comprises a coating of biologics(human ...
The Food and Drug Administration (FDA) has accepted Dynavax Technologies' heplisav biologics license application (BLA) for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of ...
Roche Group member, Genentech has received US Food and Drug Administration (FDA) official approval of priority review designation for trastuzumab emtansine Biologics License Application (BLA). Trastuzumab Emtansine is designed to treat ...
K2M, a developer of spinal solutions, has introduced its MESA Small Stature Spinal system. The MESA is a 4.5 mm pedicle screw system which utilizes Zero-Torque Technology to apply zero torsional loads, or twisting forces, to the spine ...
Tags: K2M, MESA, pedicle screw system, zero torsional loads
Inspiration Biopharmaceuticals has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the approval of IB1001, used for the treatment and prevention of bleeding in individuals with hemophilia B. ...
Tags: FDA, IB1001, intravenous recombinant factor IX protein
Specialty chemicals and biologics supplier SAFC has inked an agreement with CrystalGenomics to develop active pharmaceutical ingredients (APIs) for non-steroidal anti-inflammatory drugs (NSAID). The agreement reflects SAFC's ...
Genzyme, a Sanofi company, has submitted a supplemental biologics license application (sBLA) to the FDA and marketing authorization application (MAA) to EMA for Lemtrada to treat relapsing multiple sclerosis (RMS). In collaboration with ...
Tags: sBLA, relapsing multiple sclerosis, RMS
Aerial BioPharma, a biopharmaceutical company, has won FDA orphan drug designation for its narcolepsy drug in development. The issuance of designation from the FDA follows the completion of a Phase IIa study in which N05 demonstrated ...
Janssen Biotech and Janssen Biologics have submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) seeking approval of Simponi ...
Tags: Simponi, golimumab, active ulcerative colitis, anti-tumor necrosis factor
KineMatik has formed a strategic alliance to embed Scilligence's new cross-platform, mobile cheminformatics, and bioinformatics software tools into its electronic laboratory notebook (ELN) Scilligence's informatics products usage will ...
Tags: KineMatik, Scilligence's new cross-platform, mobile cheminformatics, ELN
Summit Media Group owned Healthcare Packaging magazine has joined hands with IQPC, a producer of cold chain conferences and events, in order to promote initiatives to increase awareness of their respective brands among buyers and sellers of ...
Tags: Healthcare Packaging, industry developments, industry applications
Teva Pharmaceutical Industries has launched Olanzapine and Fluoxetine Capsules USP 6mg/25mg, 12mg/25mg, 6mg/50mg, and 12mg/50mg. The Olanzapine and Fluoxetine Capsules are the company's generic equivalent to Symbyax. Lilly USA ...
Tags: Teva Pharmaceutical Industries, Olanzapine and Fluoxetine Capsules
DeltaTRAK has announced the launch of its new DeltaTRAK TempDot Plus time-temperature, irreversible indicator labels designed to provide positive indication that the label has been activated and is in the ‘ON’ condition. ...
Tags: DeltaTRAK, indicator labels