FDA Advisory Panel Gives Mixed Review to Sanofi’s Dengue Vaccine
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.
EC approves Roche’s Tecentriq combo vs. lung cancer
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’s migraine drug gets EU panel nod
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.
European Commission Approves Clovis Oncology’s Rubraca Tablets as Maintenance Treatment for Relapsed Ovarian Cancer
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.
European Commission Approves Blincyto In Patients With Philadelphia Chromosome Negative Minimal Residual Disease-Positive B-cell Precursor Acute Lymphoblastic Leukemia
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’ Biologics License Application for SB5 Adalimumab Biosimilar Candidate Accepted for U.S. FDA Review
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).
EU approves AstraZeneca lung cancer immunotherapy
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 hemophilia treatment wins thumbs-up from EU panel
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.
Merck’s Keytruda chemo cocktail wins EU approval
Merck & Co.’s key cancer drug Keytruda was approved for use in Europe in combination with chemotherapy in previously untreated lung cancer patients.
Novartis wins EU approval for blood cancer therapy Kymriah
Novartis received European approval for Kymriah, the Swiss drugmaker’s gene-modifying therapy for blood cancer.
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