FDA lifts its hold on vadastuximab talirine after Seattle Genetics adds new safeguards

March 6, 2017 The FDA has given Seattle Genetics the green light to continue the trials for its armed antibody dubbed SGN-CD33A (vadastuximab talirine) used for the treatment of acute myeloid leukemia. The biotech says it is implementing additional risk mitigation measures in all vadastuximab talirine studies, including “revised eligibility criteria and stopping rules for veno-occlusive disease.” … Continue reading FDA lifts its hold on vadastuximab talirine after Seattle Genetics adds new safeguards

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Novartis gets FDA Approval for LEE011 for frontline use against breast cancer

March 13, 2017 Novartis has gained the FDA approval for LEE011, its CDK 4/6 drug now approved as a frontline therapy for postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer in combination with any aromatase inhibitor. Also known as ribociclib, the drug hits the market as Kisqali with … Continue reading Novartis gets FDA Approval for LEE011 for frontline use against breast cancer

U.S. FDA and EMA Accepts Three Marketing Applications for Ertugliflozin-Containing Medicines for Adults with Type 2 Diabetes, Announced by Merck and Pfizer

March 6, 2017 Merck and Pfizer Inc. have announced that the U.S. Food and Drug Administration (FDA) has accepted for review three New Drug Applications (NDAs) for medicines containing ertugliflozin, an investigational SGLT2 inhibitor in development for helping to improve glycemic control in adults with type 2 diabetes: one for monotherapy, one for the fixed-dose … Continue reading U.S. FDA and EMA Accepts Three Marketing Applications for Ertugliflozin-Containing Medicines for Adults with Type 2 Diabetes, Announced by Merck and Pfizer

FDA Accepts the Biologics License Application for Avelumab for the Treatment of Metastatic Urothelial Carcinoma

February 28, 2017 EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, and Pfizer Inc. have announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for avelumab for Priority Review as a treatment for patients with locally advanced or metastatic urothelial carcinoma (mUC) with disease progression on … Continue reading FDA Accepts the Biologics License Application for Avelumab for the Treatment of Metastatic Urothelial Carcinoma

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REVLIMID (Lenalidomide) Approved by the European Commission as Monotherapy for the Maintenance Treatment of Patients with Newly Diagnosed Multiple Myeloma

Feb 24, 2017 Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, has announced that the European Commission (EC) has approved REVLIMID® (lenalidomide) as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation (ASCT). REVLIMID® is the first and only licensed maintenance treatment available to these patients. Multiple myeloma is … Continue reading REVLIMID (Lenalidomide) Approved by the European Commission as Monotherapy for the Maintenance Treatment of Patients with Newly Diagnosed Multiple Myeloma

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Novartis drug Zykadia receives FDA Priority Review for first-line use in patients with ALK+ metastatic NSCLC

February 23, 2017 Novartis has announced that the US Food and Drug Administration (FDA) accepted the supplemental New Drug Application (sNDA) of the company for filing, and granted Priority Review for the expanded use of Zykadia® (ceritinib) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase … Continue reading Novartis drug Zykadia receives FDA Priority Review for first-line use in patients with ALK+ metastatic NSCLC

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Roche receives EU approval of Alecensa (alectinib) for people with previously treated ALK-positive non-small cell lung cancer

21 February 2017 Roche has announced that the European Commission has granted a conditional marketing authorisation for Alecensa® (alectinib) as monotherapy for treating adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. Within one year of treatment, most people with ALK-positive NSCLC develop resistance to the current … Continue reading Roche receives EU approval of Alecensa (alectinib) for people with previously treated ALK-positive non-small cell lung cancer

European Commission Approves Once-Daily Olumiant Tablets for Treating Adults with Moderate-to-Severe Active Rheumatoid Arthritis

Feb. 13, 2017 Eli Lilly and Company and Incyte Corporation have announced that the European Commission has granted marketing authorisation for Olumiant® (baricitinib) 4 mg and 2 mg film-coated tablets in Europe for treating moderate-to-severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs). Anthony Ware, M.D., senior … Continue reading European Commission Approves Once-Daily Olumiant Tablets for Treating Adults with Moderate-to-Severe Active Rheumatoid Arthritis

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AbbVie Gets U.S. FDA Priority Review for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for Treating Chronic Hepatitis C

Feb 02, 2017 AbbVie, a global biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted priority review for its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P), being evaluated for treating all major genotypes (GT1-6) of chronic hepatitis C virus (HCV). The FDA grants priority review … Continue reading AbbVie Gets U.S. FDA Priority Review for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for Treating Chronic Hepatitis C

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FDA Accepts Two sBLAs for the KEYTRUDA (pembrolizumab) of Merck for Locally Advanced or Metastatic Urothelial Cancer

February 3, 2017 Merck has announced that the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental Biologics License Applications (sBLAs) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with locally advanced or metastatic urothelial cancer, a type of bladder cancer. In particular, the application for first-line use was accepted and granted … Continue reading FDA Accepts Two sBLAs for the KEYTRUDA (pembrolizumab) of Merck for Locally Advanced or Metastatic Urothelial Cancer