Merck Igea Luca Dezzani

FDA Approved Keytruda of Merck for Hodgkin lymphoma

March 14, 2017 Merck has received another FDA approval for Keytruda, and this time for classical Hodgkin lymphoma, marking the PD-1 blocker’s first green-light for use in liquid tumors. Regulators handed out the approval for patients who had already failed at least three therapies. The approval was a first for Merck, but it comes 9 months … Continue reading FDA Approved Keytruda of Merck for Hodgkin lymphoma

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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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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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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

Merck Igea Luca Dezzani

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

All the 22 Drugs Approved by FDA in 2016 and All the New Launches

In 2016, the Center for Drug Evaluation and Research (CDER) of FDA approved 22 novel drugs. This represents a significant slowdown compared to the 45 new medications in 2015 and 41 in 2014. Despite the negative trend of approval over the past few years, we are still going to see many launches in 2017. Here … Continue reading All the 22 Drugs Approved by FDA in 2016 and All the New Launches

Eisai plots new drug applications in US, Europe and China after Lenvima scores in head-to-head liver cancer study

January 25, 2017 Eisai says that its can­cer drug Lenvima (lenva­tinib) hit the pri­mary end­point in a Phase III study for the treatment of liver can­cer, prov­ing non-in­fe­rior to Nex­avar. That suc­cess will set up reg­u­la­tory fil­ings in the US, Eu­rope and Asia, the com­pany adds. Liver can­cer is a par­tic­u­larly big prob­lem in China, where Eisai … Continue reading Eisai plots new drug applications in US, Europe and China after Lenvima scores in head-to-head liver cancer study