Bayer HealthCare and Onyx Pharmaceuticals have announced FDA priority review designation for Nexavar (sorafenib) supplemental new drug application for the treatment of radioactive iodine-refractory differentiated thyroid cancer. Nexavar ...
Tags: New Drug Application, FDA
The US Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee has recommended approval of Bayer’s oral soluble guanylate cyclase (sGC) stimulator, riociguat, in two forms of pulmonary ...
Tags: FDA Advisory Committee
Regeneron Pharmaceuticals and Bayer HealthCare have started a new Phase 3 VEGF Trap-Eye In Vision Impairment Due to DME (VIVID EAST-DME) trial of its Eylea (aflibercept) injection. Eylea, which is formulated as an iso-osmotic solution for ...
Packaging Engineering at Rutgers University received another major boost at a Nov. 7 fundraising event organized by the Rutgers Packaging Engineering Advisory Board (RPEAB). The second annual banquet drew 120 people including School of ...
Germany-based Bayer HealthCare's Consumer Care division has begun a voluntary recall of BRONKAID Caplets Dual Action Formula in consultation with the US Food and Drug Administration (FDA), over labeling issue. Bayer has identified that ...
Tags: health care, recall, FDA, labeling issue, expiration date
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
Bayer HealthCare has filed a new drug application (NDA) with the FDA seeking approval for the oral multi-kinase inhibitor regorafenib to treat patients with metastatic colorectal cancer (mCRC). The company has even filed an application ...
Tags: oral multi-kinase inhibitor regorafenib, metastatic colorectal cancer
Bayer HealthCare Pharmaceuticals has updated the labels for its drospirenone-containing combination oral contraceptives (COCs) in the US. The revised labels state that COCs containing drospirenone may be associated with a higher risk of ...
Tags: COCs containing drospirenone, VTE, venous thromboembolism
Bayer HealthCare has submitted has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its regorafenib drug. The oral multi-kinase inhibitor regorafenib is used for the treatment of metastatic and ...
Tags: NDA, FDA, inhibitor, metastatic, GIST
Bayer HealthCare Pharmaceuticals, a research-based company, has acquired MediSapiens' new cloud computing application to analyze and visualize multi-dimensional genomics data. The OncoGenomics Explorer solution will provide Bayer with a ...
The European Commission (EC) has approved Bayer HealthCare's EYLEA (aflibercept solution for injection) at a recommended dose of 2 mg for the treatment of wet age-related macular degeneration (wet AMD). Formulated as an iso-osmotic ...
Tags: European Commission, Bayer, Aflibercept Solution, EYLEA
Liam Condon (44) has been appointed Chairman of the Executive Committee of the Bayer CropScience subgroup and Chairman of the Board of Management of Bayer CropScience effective December 1, 2012. The decision was made by the Supervisory ...
Tags: Bayer, Liam Condon, DAAD, Bayer CropScience
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
Bayer HealthCare's Japanese subsidiary, Bayer Yakuhin has signed a co-promotion agreement with Santen Pharmaceutical for Eylea (aflibercept) injection in Japan. Eylea is approved for sale in the US and Australia for the treatment of ...
The US FDA has granted priority review designation to Bayer HealthCare's new drug application (NDA) filed for regorafenib to treat patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard ...
Tags: US FDA, Bayer HealthCare, NDA