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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

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Cellectis Gains FDA Approval for Testing New Gene-Edited Cancer Treatment

Feb 7, 2017 Cellectis, the Paris-based biotech, has received an Investigational New Drug, or IND, approval from the U.S. Food and Drug Administration (FDA) for conducting phase I clinical trials with UCART123, the gene-edited product candidate of the biotech, in patients with acute myeloid leukemia, or AML, and blastic plasmacytoid dendritic cell neoplasm, or BPDCN. This is … Continue reading Cellectis Gains FDA Approval for Testing New Gene-Edited Cancer Treatment

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

biogen-ionis

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

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Lilly’s Baricitinib is Recommended by CHMP for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis (RA)

Dec. 16, 2016 Eli Lilly and Company and Incyte Corporation have announced that the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency (EMA) has issued a positive opinion recommending the approval of baricitinib - which if approved, would be marketed as Olumiant®. Baricitinib is recommended to be used for treating moderate to severe active rheumatoid arthritis … Continue reading Lilly’s Baricitinib is Recommended by CHMP for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis (RA)

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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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Janssen Submits Application Seeking Approval of Anti-Interleukin-23 Monoclonal Antibody Guselkumab to EMA for Treating Moderate-to-Severe Plaque Psoriasis

November 25 2016 Janssen-Cilag International NV has announced about the submission of a Marketing Authorization Application to the European Medicines Agency (EMA) that seeks approval of guselkumab for treating adults with moderate to severe plaque psoriasis. Guselkumab is a human monoclonal antibody targeting the protein interleukin (IL)-23, which plays an important role in developing immune-mediated … Continue reading Janssen Submits Application Seeking Approval of Anti-Interleukin-23 Monoclonal Antibody Guselkumab to EMA for Treating Moderate-to-Severe Plaque Psoriasis