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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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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

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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

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

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FDA grants Roche’s cancer immunotherapy TECENTRIQ (atezolizumab) Priority Review for the treatment of advanced bladder cancer

09 January 2017 Roche has announced that the U.S. Food and Drug Administration (FDA) has accepted the  supplemental Biologics License Application (sBLA) of the company and granted Priority Review for TECENTRIQ® (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who are ineligible for cisplatin chemotherapy, and are either previously … Continue reading FDA grants Roche’s cancer immunotherapy TECENTRIQ (atezolizumab) Priority Review for the treatment of advanced bladder cancer

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Clovis Oncology Secures FDA Approval for New Ovarian Cancer Drug

Dec 19, 2016 Clovis Oncology has got the approval from U.S. FDA for its PARP inhibitor rucaparib for treating women with advanced ovarian cancer, who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA). The brand name of the drug is Rubraca. Richard Pazdur, M.D., director of the Office … Continue reading Clovis Oncology Secures FDA Approval for New Ovarian Cancer Drug

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Biogen and Ionis Receive FDA Approval for spinal muscular atrophy drug Spinraza

December 23, 2016 FDA announced that it had provided an accelerated approval for Spinraza (nusinersen), the new drug from Biogen and Ionis, for treating rare cases of spinal muscular atrophy. It is estimated that the total sales of this drug would reach $3 billion by 2026. On this news, shares of Ionis climbed 10% and Biogen saw … Continue reading Biogen and Ionis Receive FDA Approval for spinal muscular atrophy drug Spinraza

Igeahub.com - Top Pharma News - Luca Dezzani

Pharma 2016: One Year in Review

Lots of new things happened in the pharmaceutical industry in 2016. At igeahub.com, our mission is to make the pharmaceutical world simple and clear to everyone. We want our readers to have a privileged view on the key player in the healthcare system, and we do our best to keep things simple but highly accurate. The … Continue reading Pharma 2016: One Year in Review

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US FDA accepts first biologics license application for durvalumab of AstraZeneca for the treatment of patients with bladder cancer

9 December 2016 AstraZeneca and its global biologics research and development arm, MedImmune, have announced that the US Food and Drug Administration (FDA) has accepted the first Biologics License Application (BLA) for durvalumab, a PD-L1 human monoclonal antibody (mAb). FDA has also granted priority review status with a Prescription Drug User Fee Act (PDUFA) set … Continue reading US FDA accepts first biologics license application for durvalumab of AstraZeneca for the treatment of patients with bladder cancer

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Top News from ASH 2016

New Data Shed Light on Potential Advantages of Pacritinib for Patients with Myelofibrosis Dec 06, 2016 Pacritinib significantly reduces spleen size among people with myelofibrosis who have very low levels of platelets, compared with standard therapy. This was revealed as a late-breaking study presented during the 58th Annual Meeting and Exposition of the American Society … Continue reading Top News from ASH 2016