Company Overview and News

 
Celltrion's Truxima market share surpasses 30 pct in Europe

2018-10-15 english.yonhapnews.co.kr
SEOUL, Oct. 15 (Yonhap) -- An affiliate of South Korean biopharmaceutical firm Celltrion Inc. said Monday that the market share of its biosimilar drug Truxima surpassed 30 percent in Europe during the second quarter.
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16
J&J (JNJ) Gets FDA Approval for Xarelto Label Expansion

2018-10-12 zacks
Janssen, a subsidiary of Johnson & Johnson (JNJ - Free Report) , announced that the FDA has approved the label expansion of its blood thinner, Xarelto. The drug is now approved for reduction in risk of major cardiovascular (“CV”) events including CV death, myocardial infarction (“MI”) and stroke, in patients with chronic coronary or peripheral artery disease (CAD/PAD).
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Yonhap News Summary

2018-10-11 english.yonhapnews.co.kr
The following is the first summary of major stories moved by Yonhap News Agency on Thursday.
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FDA advisory committee votes unanimously to approve Celltrion's Truxima

2018-10-11 english.yonhapnews.co.kr
SEOUL, Oct. 11 (Yonhap) -- South Korean biopharmaceutical firm Celltrion Inc. said Thursday that an advisory committee for the U.S. Food and Drug Administration (FDA) recommended the approval of its biosimilar to treat certain kinds of cancer.
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16
CORRECTED-U.S. FDA panel backs Celltrion copycat drug of Roche blood cancer drug

2018-10-11 reuters
Oct 10 (Reuters) - An advisory panel to the U.S. Food and Drug Administration on Wednesday voted unanimously in favor of Celltrion Inc’s copycat drug of Roche Holding AG’s blood cancer drug Rituxan.
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16
U.S. FDA panel backs Celltrion copycat drug of Roche blood cancer drug

2018-10-10 reuters
Oct 10 (Reuters) - An advisory panel to the U.S. Food and Drug Administration on Wednesday voted unanimously in favor of Celltrion Pharm Inc’s copycat drug of Roche Holding AG’s blood cancer drug Rituxan.
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16
UPDATE 1-U.S. FDA panel backs Celltrion copycat of Roche blood cancer drug

2018-10-10 reuters
(Reuters) - Celltrion Pharm Inc’s biosimilar of Roche Holding AG’s blockbuster cancer drug, Rituxan, on Wednesday won unanimous backing from an advisory panel to the U.S. Food and Drug Administration.
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3
Roche (RHHBY) Presents Encouraging Data on MS Drug Ocrevus

2018-10-10 zacks
Roche Holding AG (RHHBY - Free Report) announced that an early treatment with its multiple sclerosis (“MS”) drug Ocrevus significantly reduced disability progression over five years in patients with relapsing MS (“RMS”) and primary progressive MS (“PPMS”). The new data will be presented at the European Committee for the Treatment and Research in Multiple Sclerosis (ECTRIMS), scheduled to be held in Berlin, Germany from Oct 10 to 12.
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16
US FDA panel backs Celltrion copycat drug of Roche blood cancer drug

2018-10-10 channelnewsasia
An advisory panel to the U.S. Food and Drug Administration on Wednesday voted unanimously in favor of Celltrion Pharm Inc's copycat drug of Roche Holding AG's blood cancer drug Rituxan.
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2
Affimed Down After Clinical Hold on Two Early-Stage Studies

2018-10-09 zacks
Affimed N.V. (AFMD - Free Report) announced that it has placed two phase I studies evaluating its CD19/CD3-targeting T cell engager, AFM11, on clinical hold. The studies were evaluating the candidate in patients with relapsed or refractory CD19 positive B-cell non-Hodgkin lymphoma (NHL) or acute lymphoblastic leukemia (ALL). The company has notified global health authorities about its decision.
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15
J&J Inks Deal With Arrowhead for Promising Liver Candidate

2018-10-05 zacks - 1
Johnson & Johnson (JNJ - Free Report) announced that it has inked an exclusive licensing deal with Arrowhead Pharmaceuticals, Inc. to develop/commercialize the latter’s subcutaneous RNA interference (RNAi) therapy candidate, ARO-HBV. Notably, ARO-HBV is currently being evaluated in a phase I/II study for the treatment of chronic hepatitis B viral infection. While Arrowhead will complete the ongoing phase I/II program on the candidate, J&J will take over its development stages from phase IIb onward.
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5
Roche Holding, YY, eBay and PayPal highlighted as Zacks Bull and Bear of the Day

2018-10-05 zacks
Chicago, IL – October 5, 2018 – Zacks Equity Research highlights Roche Holding (RHHBY - Free Report) as the Bull of the Day, YY Inc. (YY - Free Report) as the Bear of the Day. In addition, Zacks Equity Research provides analysis on eBay (EBAY - Free Report) and PayPal (PYPL - Free Report) .
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BioLineRx Stock Up on Stake Increase in Lead Cancer Program

2018-10-04 zacks
BioLineRx Ltd. (BLRX - Free Report) announced that it has inked a deal with privately held Biokine Therapeutics for increasing its stake in its lead oncology program, BL-8040. The candidate, a CXCR4 antagonist, is currently being developed in late-stage studies for treating different types of solid tumors and hematological indications, such as stem cell mobilization (SCM), acute myeloid leukemia and immunotherapy for multiple types of solid tumors.
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2
Novartis, Boston Pharma Ink Deal for 3 Anti-Infective Drugs

2018-10-03 zacks
Novartis AG (NVS - Free Report) announced that it has entered into a licensing and equity agreement with Boston Pharmaceuticals for the development of three novel anti-infective drug candidates that are part of the Novartis Infectious Diseases portfolio.
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10
Roche Gets FDA Approval for New Formulation of Asthma Drug

2018-10-01 zacks
Roche Holding AG (RHHBY - Free Report) announced that the FDA has approved expansion prefilled syringe formulation of its asthma drug, Xolair(omalizumab). Xolair is approved for use in a 75 mg/0.5 mL and 150 mg/1 mL single-dose PFS formulation for both the approved indications of the drug - allergic asthma and chronic idiopathic urticaria (chronic hives without a known cause). Xolair is currently available in a 150 mg single-dose vial with lyophilized, sterile powder for reconstitution.
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CUSIP: H69293217