The U.S. Food and Drug Administration approved Bristol Myers Squibb’s Onureg (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission or CR with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy.
As pharma companies bolster their pipelines via multibillion-dollar acquisitions, drug manufacturers continue to heavily invest in the oncology space.
Shionogi & Co. Ltd. announced results from APEKS-NP, an international, double-blind, randomized Phase III clinical trial evaluating the efficacy and safety of the investigational antibiotic cefiderocol in patients with nosocomial pneumonia (NP).
Celgene Corporation announced that the company submitted a New Drug Application to the U.S. FDA for ozanimod for the treatment of adults with relapsing forms of multiple sclerosis (RMS).
JHL Biotech received a positive Scientific Advice from the Committee for Medicinal Products for Human Use of the European Medicines Agency related to the EU approval pathway for its proposed bevacizumab biosimilar JHL1149 to treat patients with non-small cell lung cancer.
J&J’s Janssen Pharmaceutical Companies submitted a Marketing Authorization Application to the EMA for apalutamide for non-metastatic castration-resistant prostate cancer.
The fact that the European Medicines Agency again pushed back the deadline for ISO IDMP (Identification of Medicinal Products) compliance has not stopped the life sciences technology and services industry from promoting IDMP software and solutions.
The European Commission granted marketing authorization for BioMarin Pharmaceutical’s Brineura for the treatment of tripeptidyl peptidase 1 (TPP1) deficiency.
Paul Ranson, of global law firm Morgan Lewis’ London Life Science’s Practice, examines how the UK Biopharma must now adapt to a changing landscape.
Concerted effort by governments, regulators, and industry is rapidly expanding development of new therapies for the more than 7,000 known rare diseases.
