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Arzerra

Type: Product

Name: Arzerra

First reported May 17 2013 - Updated May 18 2013 - 1 reports

Patent “Silent Disclaimers” Established Under Rituxan Ruling, Biogen Worries

Biogen Idec and Genentech petition the Federal Circuit to rehear en banc a ruling that Biogen’s Rituxan patent claim does not cover GlaxoSmithKline’s Arzerra; they say that failing to expressly object to an examiner’s views does not imply they disavowed ... [Published The Rose Sheet - May 17 2013]

Entities: Rituxan, Patent Claim, Patent

First reported May 17 2013 - Updated May 17 2013 - 1 reports

Biogen Idec Inc

BRIEF-Genentech and Biogen Idec file for a re-hearing of U.S. Court Of Appeals decision in Arzerra patent case

Genmab A/S ... [Published XE - May 17 2013]

Entities: Arzerra, Biogen Idec Inc, Patent

First reported May 15 2013 - Updated May 16 2013 - 3 reports

Daratumumab Data to be Presented at ASCO Annual Meeting

Media Release-- Latest from daratumumab Phase I/II study in relapsed/refractory multiplemyeloma-- Pre-clinical data from HuMax-TF-ADC program-- Abstracts available online at ASCO websiteCopenhagen, Denmark; May 16, 2013 – Genmab A/S (OMX: GEN) announced ... [Published EuroInvestor - May 15 2013]

Entities: Genmab AS, Antibody, Arzerra, Phase I/II, Multiple Myeloma

First reported May 07 2013 - Updated May 07 2013 - 5 reports

Baxter International Inc

Genmab Announces Financial Results For The First Quarter Of 2013

(GLOBE NEWSWIRE) -- Interim Report First Quarter 2013 Arzerra (r) received approval in Japan Arzerra net sales increased 65% over Q1 2012 Manufacturing facility sold to Baxter Improved operating result by DKK 73 million over Q1 2012 "We expect 2013 to ... [Published TheStreet.com - May 07 2013]

Entities: Genmab AS, Arzerra, ofatumumab, Patient, Baxter International Inc

First reported May 07 2013 - Updated May 07 2013 - 1 reports

GlaxoSmithKline plc

Arzerra sales help Genmab turn loss to profit

* Q1 operating profit 29 mln DKK vs 44 mln loss* Revenue up 70 percent to 160 mln DKK* Still expects FY op loss of 40-90 mlnCOPENHAGEN, May 7 (Reuters) - Danish biotech company Genmab A/S swung to a first-quarter operating profit on the back of higher ... [Published Yahoo! UK and Ireland - May 07 2013]

Entities: Genmab AS, Arzerra, GlaxoSmithKline plc, Blood Cancer, Cash Position

First reported May 04 2013 - Updated May 04 2013 - 1 reports

FDA Food & Drug Administration

Daratumumab Receives Breakthrough Therapy Designation From US Food and Drug Administration

You are here: Home >> SPi World News >> World Market Sector News"Breakthrough designation allows us to work together with our strategic partner Janssen and the FDA to expedite the development of daratumumab in multiple myeloma, so patients ... [Published SPi World News - May 04 2013]

Entities: Genmab AS, Multiple Myeloma, FDA Food & Drug Administration

First reported May 02 2013 - Updated May 03 2013 - 2 reports

bendamustine

Ofatumumab/Bendamustine Combo Shows Promise in Leukemia Patients

Results have been reported from a phase II study of ofatumumab (Arzerra; Genmab) in combination with bendamustine in patients with untreated or relapsed chronic lymphocytic leukemia (CLL).A total of 97 patients were treated in the study, and 87% of the ... [Published PT Community - May 03 2013]

Entities: ofatumumab, bendamustine, Patient

First reported May 01 2013 - Updated May 02 2013 - 3 reports

Genmab Announces Top-Line Phase II Results for Ofatumumab Combined With Bendamustine in Untreated and GlobeNewswire

(GLOBE NEWSWIRE) -- Genmab A/S (GEN.CO) announced today top-line results from a Phase II study of ofatumumab in combination with bendamustine in patients with untreated or relapsed chronic lymphocytic leukemia (CLL).A total of 97 patients were treated ... [Published Yahoo! Finance - May 01 2013]

Entities: ofatumumab, Genmab AS, bendamustine, Patient

First reported Apr 19 2013 - Updated Apr 20 2013 - 1 reports

PCYC Completes RESONATE Enrollment Zacks

Pharmacyclics, Inc. (PCYC) recently announced the completion of enrollment in its phase III study RESONATE, which is being conducted to evaluate ibrutinib versus Arzerra (ofatumumab) in patients with relapsed or refractory chronic lymphocytic leukemia ... [Published Yahoo! Finance - Apr 19 2013]

Entities: Pharmacyclics Inc, Ibrutinib, Arzerra, Catalyst Pharmaceutical Partners Inc, QLT Inc

First reported Apr 19 2013 - Updated Apr 19 2013 - 1 reports

Sandoz’ Loryna Strategy Validated; Bayer’s Yaz Patent Struck Down A Year Before Expiration

Actavis is relaunching its version of the oral contraceptive after the Federal Circuit reverses a lower court and finds Bayer’s patent is invalid due to obviousness; the appeals court also finds that Biogen Idec’s Rituxan patent does not block GSK’s ... [Published The Rose Sheet - Apr 19 2013]

Entities: Sandoz, Bayer AG, Patent

First reported Apr 16 2013 - Updated Apr 17 2013 - 3 reports

Genmab Announces US Appeals Court Judgment In Favour Of Arzerra - Quick Facts

Genmab A/S DKK (GNMSF.PK, GEN) Tuesday said the Appelate Court for the Federal Circuit has upheld the District Court's judgment in favor of GlaxoSmithKline in a patent infringement case involving Arzerra.The lawsuit was originally brought against GSK, ... [Published RTTNews.com - Apr 16 2013]

Entities: Arzerra, Genmab AS, Genentech Inc, Biogen Idec Inc, Antibody

First reported Apr 16 2013 - Updated Apr 17 2013 - 2 reports

Federal Circuit Affirms Decision Finding Biogen’s Patent Not Infringed by Arzerra

| Holman's Biotech IP BlogHome » Blogs » Today in Biogen Idec v. GlaxoSmithKline a divided panel of the Federal Circuit affirmed a district court’s decision that GSK's monoclonal antibody product Arzerra does not infringe Biogen's patent number 7,682,612. ... [Published BioPortfolio - Apr 17 2013]

Entities: Arzerra, Patent, Biotechnology

Quotes

This Media Release contains forward looking statements. The words "believe-, "expect-, "anticipate-, "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on www.genmab.com. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements in relation to actual results, unless required by law."

Genmab A/S: Daratumumab Data to be Presented at ASCO Annual Meeting [Published FinanzNachrichten.de - May 15 2013]

...Japan Arzerra net sales increased 65% over Q1 2012 Manufacturing facility sold to Baxter Improved operating result by DKK 73 million over Q1 2012 "We expect 2013 to be another exciting and productive year at Genmab and are working hard to fulfill the objectives we set for this year. We were pleased to gain approval for Arzerra in Japan, the first Asian territory to give marketing authorization to the product, as well as to see growing sales during Q1. We recently reported impressive top line results from a Phase II study using ofatumumab together with bendamustine to treat CLL patients and look forward to reporting important Phase III data from our frontline CLL study with ofatumumab in the coming time" said Jan van de Winkel, Ph D , Chief Executive Officer of Genmab

Genmab Announces Financial Results For The First Quarter Of 2013 [Published TheStreet.com - May 07 2013]

"Breakthrough designation allows us to work together with our strategic partner Janssen and the FDA to expedite the development of daratumumab in multiple myeloma, so patients suffering from this devastating type of blood cancer could potentially receive access to this medicine much sooner" said Jan van de Winkel, Ph D , Chief Executive Officer of Genmab

Daratumumab Receives Breakthrough Therapy Designation From US Food and Drug Administration [Published SPi World News - May 04 2013]

"These data show encouraging clinical responses in patients treated with ofatumumab plus bendamustine, a commonly used chemotherapeutic agent, in both untreated and relapsed CLL. This is only the first set of key data we expect to report for ofatumumab over the next 15 months. Data from five pivotal studies are due during this time period, including results from a Phase III study of ofatumumab in frontfront line CLL during the first half of 2013" said Jan van de Winkel, Ph D , Chief Executive Officer of Genmab

FDA Grants Breakthrough Status to Johnson & Johnson, Genmab A/S Cancer Drug, Stock Up +12.70 (8.7 ... [Published BioSpace - May 02 2013]

More Content

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Patent “Silent Disclaimers” Established Under R... [Published BioPortfolio - May 18 2013]
Patent “Silent Disclaimers” Established Under R... [Published The Rose Sheet - May 17 2013]
BRIEF-Genentech and Biogen Idec file for a re-h... [Published XE - May 17 2013]
Daratumumab Data to be Presented at ASCO Annual... [Published EuroInvestor - May 15 2013]
Daratumumab Data to be Presented at ASCO Annual... [Published NASDAQ OMX - May 15 2013]
Genmab A/S: Daratumumab Data to be Presented at... [Published FinanzNachrichten.de - May 15 2013]
Capital Increase in Genmab as a Result of Emplo... [Published Noodls - May 15 2013]
Arzerra sales help Genmab turn loss to profit [Published Yahoo! UK and Ireland - May 07 2013]
Genmab Announces Financial Results For The Firs... [Published TheStreet.com - May 07 2013]
Genmab Announces Financial Results for the Firs... [Published Yahoo! Finance - May 07 2013]
Genmab Announces Financial Results for the Firs... [Published Street Insider - May 07 2013]
Genmab A/S: Genmab Announces Financial Results ... [Published FinanzNachrichten.de - May 07 2013]
Genmab Announces Financial Results for the Firs... [Published GlobeNewswire: Acquisitions News - May 07 2013]
Genmab Announces Financial Results for the Firs... [Published NASDAQ OMX - May 07 2013]
Daratumumab Receives Breakthrough Therapy Desig... [Published SPi World News - May 04 2013]
Ofatumumab/Bendamustine Combo Shows Promise in ... [Published PT Community - May 03 2013]
FDA Grants Breakthrough Status to Johnson & Joh... [Published BioSpace - May 02 2013]
Genmab Announces Top-Line Phase II Results for ... [Published Yahoo! Finance - May 01 2013]
Genmab Announces Top-Line Phase II Results for ... [Published Interest!ALERT - May 01 2013]
Genmab A/S: Genmab Announces Top-Line Phase II ... [Published FinanzNachrichten.de - May 01 2013]
Arzerra First Quarter 2013 Net Sales Figures [Published GlobeNewswire: Acquisitions News - Apr 24 2013]
Sandoz’ Loryna Strategy Validated; Bayer’s Yaz ... [Published The Rose Sheet - Apr 19 2013]
PCYC Completes RESONATE Enrollment Zacks [Published Yahoo! Finance - Apr 19 2013]
Biogen Idec, Inc. v. GlaxoSmithKline LLC (Fed. ... [Published JD Supra - Apr 18 2013]
Federal Circuit Affirms Decision Finding Biogen... [Published BioPortfolio - Apr 17 2013]
Federal Circuit Affirms Decision Finding Biogen... [Published Holman's Biotech IP Blog - Apr 16 2013]
4 Healthcare Stock Stories For Tuesday Investme... [Published Wall St. Cheat Sheet - Apr 16 2013]
Genmab Announces US Appeals Court Judgment In F... [Published RTTNews.com - Apr 16 2013]
UPDATE: Glaxo (GSK) wins appeals court ruling o... [Published Street Insider - Apr 16 2013]
Genmab Announces Final US Court Judgment in Fav... [Published Tradesignal Online - Apr 16 2013]

Blogs

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Federal Circuit Affirms Decision Finding Biogen... [Published Holman's Biotech IP Blog - Apr 16 2013] Today in Biogen Idec v. GlaxoSmithKline a divided panel of the Federal Circuit affirmed a district court’s decision that GSK's monoclonal antibody product Arzerra does not infringe Biogen's patent number 7,682,612. I discussed the district court's decision ...
4 Healthcare Stock Stories For Tuesday Investme... [Published Wall St. Cheat Sheet - Apr 16 2013] Biogen IDEC ( NASDAQ: BIIB ): Current price $201.70 The United States Court of Appeals for the Federal Circuit in Washington has ruled against an appeal made by Biogen and Roche’s Genetech in a patent infringement case against GlaxoSmithKline ...
Japanese approval of Arzerra triggers milestone... [Published PBR - News - Mar 27 2013] The Japanese Ministry of Health, Labor and Welfare (MHLW) approval of Arzerra (ofatumumab) has triggered a DKK20m ($3.45m) milestone payment from GlaxoSmithKline (GSK) to Genmab. ...
Human medicines European Public Assessment Repo... [Published Pending EC decisions and European Public Assess ... - Mar 07 2013]

Press Releases

sort by: Date \| Relevance
Genmab Announces Financial Results for the Firs... [Published GlobeNewswire: Acquisitions News - May 07 2013]
Arzerra First Quarter 2013 Net Sales Figures [Published GlobeNewswire: Acquisitions News - Apr 24 2013]
Genmab Announces Final US Court Judgment in Fav... [Published GlobeNewswire: Acquisitions News - Apr 16 2013]
Arzerra Receives Approval in Japan [Published GlobeNewswire: Acquisitions News - Mar 25 2013]
Arzerra Fourth Quarter and Full Year 2012 Net S... [Published GlobeNewswire: Acquisitions News - Feb 06 2013]