Celgene Corporation announced that the European Commission approved two new triplet regimens based on the company’s proprietary IMiD treatments, Revlimid (lenalidomide) and Imnovid (pomalidomide).
Akcea Therapeutics Inc. and Ionis Pharmaceuticals Inc. announced that Waylivra received conditional marketing authorization from the European Commission as the only therapy for FCS.
A mixed review from a U.S. FDA panel of experts could sink the chances of a green light for Sanofi’s dengue vaccine Dengvaxia.
Roche received European Commission (EC) approval for the company’s Tecentriq drug in combination with Avastin and chemo as an initial treatment for people with a specific type of lung cancer.
Teva Pharmaceutical Industries said a European Medicines Agency panel recommended approving the migraine treatment Ajovy, a drug being counted on to revive the company’s fortune.
Clovis Oncology Inc. announced that the European Commission approved the use of Rubraca (rucaparib) for a second indication: as monotherapy for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Amgen announced that the European Commission approved an expanded indication for Blincyto monotherapy to include adult patients with Philadelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease greater than or equal to 0.1 percent.
Samsung Bioepis Co. Ltd. announced that the U.S. Food and Drug Administration accepted for review the company’s Biologics License Application under the 351(k) pathway for SB5, a biosimilar candidate referencing Humira (adalimumab).
AstraZeneca’s immunotherapy drug Imfinzi was approved in Europe for use in lung cancer patients with inoperable disease that had advanced locally but not spread widely around the body.
Bayer AG’s long-acting treatment for hemophilia A won a recommendation from a European Medicines Agency (EMA) panel for the treatment of the rare genetic disorder in which blood does not clot easily.
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April 2019 Focus: Healthcare agency & network profiles, industry overview & awards, and more!
