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Zacks News
Exelixis & Bristol-Myers Initiate Trial on Opdivo-Cabometyx
by Zacks Equity Research
Exelixis (EXEL) initiated a phase III trial, CheckMate 9ER to evaluate Opdivo in combination with Cabometyx or Opdivo and Yervoy in combination with Cabometyx versus Sutent in patients with RCC.
BioLineRx/Roche Scan BL-8040-Tecentriq for Pancreatic Cancer
by Zacks Equity Research
BioLineRx Ltd. (BLRX) announced that its partner Genentech, has initiated a phase Ib/II study, evaluating BL-8040 in combination Tecentriq (atezolizumab) for treatment of patients with metastatic pancreatic ductal adenocarcinoma.
Shire Completes NDA Filing for Hemophilia Drug with FDA
by Zacks Equity Research
Shire plc (SHPG) recently announced that it has filed an investigational new drug (IND) application with the FDA, seeking approval for its recombinant factor VIII (FVIII) gene therapy candidate, SHP654, for the treatment of patients with Hemophilia A.
Puma (PBYI) Ends Patient Enrollment in Phase III Cancer Trial
by Zacks Equity Research
Puma Biotechnology, Inc. (PBYI) announced that it has completed enrollment of patients in a phase III study to evaluate its lead pipeline candidate PB272 in combination with Xeloda for treatment of third-line HER2-positive metastatic breast cancer.
Array (ARRY) Submits NDA for Melanoma Combination Therapy
by Zacks Equity Research
Array BioPharma (ARRY) announced that it has submitted two new drug applications (NDAs) to FDA, seeking approval for the combination of binimetinib and encorafenib to treat patients with BRAF-mutant advanced, unresectable or metastatic melanoma.
Celsion Completes Ovarian Cancer Trial Enrollment, Stock Up
by Zacks Equity Research
Celsion Corp. (CLSN) shares rose after the company has announced completion of enrolment in a phase Ib study, evaluating its immunotherapy, GEN-1 in combination with neoadjuvant chemotherapy for treatment of advanced ovarian cancer.
Roche (RHHBY) Launches Cobas Test for Bacterial Infections
by Zacks Equity Research
Roche Holdings AG (RHHBY) launched CE-IVD, the cobas MRSA/SA nucleic acid test be used on the cobas Liat System for the qualitative detection and differentiation of methicillin-resistant MRSA and SA at the point of care.
The Zacks Analyst Blog Highlights: Merck, Sanofi, Roche, Esperion and Teva
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Merck, Sanofi, Roche, Esperion and Teva
Teva's (TEVA) Filing for Biosimilar Rituxan Accepted by FDA
by Zacks Equity Research
Teva Pharmaceutical Industries Ltd. (TEVA) and Korean partner Celltrion, Inc., announced that the FDA has accepted for review their Biologics License Application (BLA) for CT-P10, a proposed biosimilar to Roche Holding AG's (RHHBY) Rituxan (rituximab).
Roche's (RHHBY) Leukemia Drug Gets Prime Status in EU
by Zacks Equity Research
Roche (RHHBY) announced that its investigational drug polatuzumab vedot in combination with MabThera and bendamustine was granted prime status in the EU.
Pharma Stock Roundup: Sanofi RA Drug Gets EU Nod, Merck CETP Inhibitor Surprises
by Arpita Dutt
Merck's (MRK) results on its CETP inhibitor took the investment community by surprise while Sanofi gained EU approval for its rheumatoid arthritis (RA) drug.
Novartis' Erelzi, Biosimilar of Enbrel Approved In Europe
by Zacks Equity Research
Novartis AG (NVS) announced that the European Commission (EC) has approved Erelzi ??? the biosimilar version of Enbrel.
Merck's CETP Inhibitor Reduces CV Risk in Phase III Study
by Zacks Equity Research
Merck & Co., Inc. (MRK) announced that a large late-stage cardiovascular outcomes study (REVEAL) evaluating anacetrapib, a cholesterol-lowering medicine, met the primary endpoint by reducing cardiovascular (CV) risk.
Roche's (RHHBY) Combination Cancer Remedy Wins FDA Approval
by Zacks Equity Research
Roche (RHHBY) announced that the FDA has granted approval to the subcutaneous injection of its marketed lymphoma drug MabThera/Rituxan as Rituxan Hycela for the treatment of adults with different types of blood cancers.
Allergan Continues to Focus on Acquisitions and Branded Unit
by Zacks Equity Research
We issued an updated research report on Allergan plc (AGN) on Jun 23.
Pharma Stock Roundup: NVS Scores with Positive Data, Shire ADHD Drug Gets FDA Nod
by Arpita Dutt
All major pharma stocks were up this week with companies like Novartis (NVS) presenting positive data and others gaining FDA approval.
Novartis Announces Positive Results for Cardiovascular Drug
by Zacks Equity Research
Novartis AG (NVS) announced top-line results from the global phase III study, CANTOS on cardiovascular drug.
Exelixis's Cabometyx Positive for First-Line Kidney Cancer
by Zacks Equity Research
Exelixis, Inc. (EXEL) announced results from an analysis of the data from the phase II trial, CABOSUN evaluating Cabometyx to Sutent for kidney cancer.
Clovis Up Nearly 50% on Solid Data from Ovarian Cancer Study
by Zacks Equity Research
Clovis Oncology, Inc. (CLVS) shares soared nearly 50% on Monday after it announced positive top-line results from a pivotal late-stage maintenance study on its newly launched ovarian cancer drug, Rubraca.
Novartis (NVS) Biosimilar of MabThera Approved in the EU
by Zacks Equity Research
Novartis AG (NVS) announced that its generic arm, Sandoz, has received European Commission (EC) approval for Rixathon.
Celgene Presents Interim Results from Cancer Drug Study
by Zacks Equity Research
Celgene Corporation (CELG) announced encouraging results from an interim analysis of a phase IIIb study, MAGNIFY, on Revlimid.
Does Roche Holding (RHHBY) Look to be a Great Value Pick?
by Zacks Equity Research
Roche Holding is an inspired choice for value investors, as it is hard to beat its incredible lineup of statistics on this front.
J&J Immunotherapy Darzalex Ok'd for Expanded Combination Use
by Zacks Equity Research
Johnson & Johnson (JNJ) announced that its immunotherapy, Darzalex has been approved for use in combination with Celgene Corporation's (CELG) multiple myeloma drug Pomalyst (pomalidomide) and dexamethasone.
Here's Why Clovis (CLVS) Stock is Up Almost 350% in One Year
by Zacks Equity Research
Shares of Clovis Oncology, Inc. (CLVS) continue to witness an upside. The uptrend started in the third quarter of 2016.
Puma (PBYI) Stock Surges as Neratinib Nears FDA Approval
by Zacks Equity Research
Puma's stock has significantly outperformed the Zacks classified Medical-Biomed/Genetics industry in the year so far after an FDA advisory committee recommended approval for neratinib in May this year.