Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.FDA advisory panel recommends Pfizer’s Mylotarg for acute myeloid leukemia
The FDA advisory panel voted 6:1 in favor of the investigational antibody-drug conjugate. ODAC with its voting affirmed that the results of the phase 3 ALFA-0701 trial showed
The FDA advisory panel voted 6:1 in favor of the investigational antibody-drug conjugate. ODAC with its voting affirmed that the results of the phase 3 ALFA-0701 trial showed
The deal will also include an additional payment of up to $100m based on the achievement of certain milestones. Founded in 1983 and based in Meriden, Protein
FDA has also accepted sNDA for powder for oral suspension (PFOS) formulation of Sprycel. The sNDA has been submitted based on data from CA180-226, which is an ongoing phase
The pharma company had filed a lawsuit alleging that Teva Pharmaceutical subsidiary Actavis’ alternative salt forms had directly infringed the Alimta vitamin regimen patent in the UK, Spain,
The global and multicenter program will assess the safety and efficacy of fitusiran in three separate trials, including patients with hemophilia A and B with or without inhibitors
The partners will jointly advance zoliflodacin in a phase 3 trials that will be done in countries like South Africa, the US, and Thailand. Zoliflodacin’s pharmacological studies are
SHP654 is an investigational factor VIII (FVIII) gene therapy, which will protect hemophilia A patients against bleeds through delivering long-term and constant level of factor expression. Shire had
The deal will pertain to treating patients with BGB-A317 in the US, Europe, Japan and rest of world outside Asia. In this regard, BeiGene will receive a total
The clinical hold has been placed on Keynote-183, Keynote-185 and Keynote-023 combination studies of the anti-PD-1 therapy, Keytruda, to treat blood cancer multiple myeloma. FDA has decided to
As part of the $55.5m deal, Samsung BioLogics will manufacture Tildrakizumab, which is an investigational IL-23p19 inhibitor that is being assessed for the treatment of moderate to severe plaque