The U.S. FDA approved Novartis AG’s Rydapt as an initial treatment for acute myeloid leukemia (AML) as well as certain other blood disorders.
Sanofi’s net sales for first-quarter 2017 amounted to €8.65 billion, up 11.1% on a reported basis and 8.6% at CER, reflecting the acquisition of Boehringer Ingelheim’s CHC business and full consolidation of Sanofi’s European vaccine operations. At constant structure and CER, net sales for the 2017 first quarter were up 3.5% year over year.
European Commission Extends Approval for Janssen’s Darzalex to Include Multiple Myeloma Patients Who Have Received at Least One Prior Therapy
Janssen-Cilag International NV announced that the European Commission granted approval to Darzalex (daratumumab) for use in combination with lenalidomide and dexamethasone, or bortezomib – which is marketed as Velcade – and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
There is excitement running through the halls of Moderna Therapeutics following the publishing of interim data from a Phase I study of its messenger RNA (mRNA) therapy for avian H10N8 influenza.
BioMarin Pharmaceutical announced that the U.S. FDA approved Brineura (cerliponase alfa) for the rare disease, late infantile neuronal ceroid lipofuscinosis type 2 (CLN2).
Regeneron and Sanofi Announce Kevzara Biologics License Application Resubmission Accepted for Review by U.S. FDA
Regeneron Pharmaceuticals Inc. and Sanofi announced that the U.S. Food and Drug Administration accepted the resubmission of the Biologics License Application for Kevzara (sarilumab) as a Class I response with a two month review timeline. Per the Prescription Drug User Fee Act (PDUFA), the new target action date for the potential rheumatoid arthritis treatment is May 22, 2017.
The U.S. Food and Drug Administration said it approved Bayer AG’s drug Stivarga to treat liver cancer, the first such approval in nearly a decade.
Bristol-Myers Squibb Co. reported higher-than-expected first-quarter 2017 earnings, helped by increased sales of the cancer drugs Opdivo and Yervoy and the blood thinner Eliquis.
Celgene Corp. reported lower-than-expected first-quarter 2017 revenue with Otezla sales well short of Wall Street estimates, but the U.S. biotechnology company promised the psoriasis drug was poised to rebound.