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Zacks News
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.
Why is Alnylam's (ALNY) Stock Close to 100% this Year?
by Zacks Equity Research
Shares of Alnylam Pharmaceuticals, Inc. (ALNY) soared 93.3% this year so far massively outperforming the 2.6% increase registered by the Zacks classified Biomed/Genetics industry during this period.
Epizyme Provides Positive Interim Data on EZH2 Inhibitor
by Zacks Equity Research
Epizyme, Inc. (EPZM) announced positive interim data from an ongoing phase II study evaluating pipeline candidate tazemetostat as a monotherapy in patients with relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma
Exelixis Initiates Cabozantinib-Tecentriq Combination Trial
by Zacks Equity Research
Exelixis, Inc. (EXEL) announced that it initiated the dose-escalation stage of a phase Ib trial of cabozantinib in combination with Roche's (RHHBY) Tecentriq.
Why is Kite Pharma (KITE) Stock Up Close to 100% this Year?
by Zacks Equity Research
Shares of Kite Pharma, Inc. (KITE) were up around 5.6% on Thursday.