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85 articles with Sandoz
Sandoz Inc. and its affiliate, Novartis Pharmaceuticals Corporation, voluntarily recall select blister packages of products in the U.S. due to packaging requirements for child resistance
Voluntary recall and notice of corrective action issued after discovering certain blister card packages distributed in the U.S. do not meet U.S. child-resistant packaging requirements
Basel, Switzerland-based Novartis announced that between the ASCO meeting and the 23rd Annual Congress of the European Hematology Association (EHA) meeting being held June 14 to 17 in Stockholm, Sweden, it will be presenting 84 abstracts.
The U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) to Sandoz, a division of Novartis, for its Biologics Licensing Application (BLA) for its biosimilar to Roche/Genentech’s Rituxan.
A proposed $20 million settlement has been reached in a class action lawsuit involving the antibiotic drug Solodyn®.
Four Canadian provinces add ErelziTM (etanercept) to provincial drug plans for the treatment of multiple inflammatory diseases
Manitoba, Saskatchewan, Alberta and Newfoundland are the most recent provinces to add Sandoz biosimilar Erelzi (etanercept) to provincial drug plans for the treatment of multiple inflammatory diseases.
If a brand name drug loses patent protection, that often marks the date when companies can begin marketing generic versions of the drug. However, this has grown more complicated with the approvals of biosimilars.
Amgen gets to breathe a small, but temporary sigh of relief as a court case determining whether or not Novartis subsidiary Sandoz can launch its biosimilar challenge to blockbuster rheumatoid arthritis drug Enbrel has been delayed.
Acquired portfolio of 25 US FDA-approved abbreviated new drug applications (ANDAs) from Sandoz Inc.
STEM CELLS Translational Medicine Release: Scientists Identify Molecule That May Help Aid Kidney Repair
A new study appearing in STEM CELLS Translational Medicine shows how understanding the way a type of molecule called CD133 functions might contribute to an understanding of the mechanisms involved in kidney repair.
The test detects 14 types of HPV from specimens collected for cervical cancer screening in the BD SurePath liquid based cytology vial.
The first of the pink slips at Sandoz' generic-drug manufacturing facility in Broomfield, Colo. have been handed out.
CASI intends to select and commercialize certain products from the portfolio that have unique market opportunity and cost-effective manufacturing in China and/or in the U.S.
Here’s a look at the top six generic drug companies to work for.
Both companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of products, and will have a cost and profit share arrangement globally.
Sandoz announced today that the FDA has accepted its BLA for proposed biosimilar adalimumab to the reference medicine, Humira.
Sandoz Announces New Phase I Data Showing Proposed Biosimilar Pegfilgrastim Matches Reference Medicine
The Phase I study, conducted in healthy volunteers, confirmed that Sandoz biosimilar pegfilgrastim matches the reference biologic in terms of PK, PD, safety and immunogenicity profiles.
Studies included two innovative trials involving switching and two pharmacokinetic (PK) and pharmacodynamic (PD) studies.
Pegfilgrastim is a long-acting formulation of filgrastim and Sandoz is seeking approval for use of its biosimilar in the same indication as the reference medicine.
Sandoz Proposed Biosimilar Adalimumab Matches Reference Biologic In Terms Of Efficacy And Safety In Long-Term Study