AVELUMAB was accepted for Priority Review by FDA. The drug is sponsored by Merck KGaA, Darmstadt, Germany, which in the US and Canada operates as EMD Serono. The drug is being developed through an alliance between Merck KGaA and and Pfizer Inc. The immuno-oncology alliance will jointly develop and commercialize avelumab and advance Pfizer’s PD-1... […]
DARZALEX received FDA approval in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Janssen Biotech said FDA approved Nov. 21 daratumumab (Darzalex) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
AMGEN and ALLERGAN plc. have submitted a Biologics License Application to FDA for ABP 215, a biosimilar candidate to Avastin (bevacizumab). ABP 215 is the most advanced of the four oncology biosimilar medicines that Amgen and Allergan are collaborating on. The companies said they believe this submission is the first bevacizumab biosimilar application submitted to FDA.
NAPABUCASIN received the Orphan Drug Designation from FDA in the treatment of pancreatic cancer. This is the second Orphan Drug Designation for napabucasin, an orally administered agent designed to inhibit cancer stemness pathways by targeting STAT3; the first designation was for gastric cancer including gastroesophageal junction cancer. Napabucasin, which is being developed by Boston Biomedical,... […]
PKC412 (midostaurin) was been granted Priority Review for new drug application for the treatment of acute myeloid leukemia in newly-diagnosed adults with an FMS-like tyrosine kinase-3 mutation, as well as for the treatment of advanced systemic mastocytosi. The premarket approval application for the PKC412 (midostaurin) FLT3 companion diagnostic, developed by Novartis in collaboration with Invivoscribe... […]
MYLAN N.V. and Biocon Ltd. announced submission of Mylan’s biologics license application for MYL-1401O, biosimilar trastuzumab, to the FDA through the 351(K) pathway. This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast and gastric cancers. Mylan and Biocon believe that this has the potential to be the... […]
THE JOHNS HOPKINS UNIVERSITY and Bristol-Myers Squibb Co. announced a five-year collaboration aimed to answer why some patients respond to checkpoint blockers and some do not, and to develop more effective combination immunotherapies. Projects included in the collaboration will span laboratory research on patients’ tumor samples and several early-stage clinical trials led by Johns Hopkins... […]
AMGEN and Janssen Biotech Inc. announced a collaboration to evaluate the combination of Amgen’s Kyprolis (carfilzomib) and Janssen’s Darzalex (daratumumab) in multiple clinical studies in patients with multiple myeloma. Under the agreement, the companies may elect to supply drug only or supply drug and share development costs on a study-by-study basis.The first study initiated as... […]
OPDIVO (nivolumab) received FDA approval for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy.
