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News Breaks
February 3, 2014
07:12 EDTPDLI, RHHBYPDL BioPharma reaches agreement in litigation with Genentech and Roche
PDL BioPharma (PDLI) has entered into an agreement with Genentech and F. Hoffmann-La Roche (RHHBY) which resolves all outstanding legal disputes between the parties, including its Nevada litigation with Genentech and Roche and its arbitration proceedings with Genentech related to the audit of royalties on sales. Under the terms of the agreement, effective retroactively to August 15, 2013, Genentech will pay a fixed royalty rate of 2.125% on worldwide sales of Avastin, Herceptin, Lucentis Xolair, Kadcyla and Perjeta. Genentech will pay these royalties on all worldwide sales of Avastin, Herceptin, Xolair, Perjeta and Kadcyla occurring on or before December 31, 2015. With respect to Lucentis, Genentech will owe no royalties on U.S. sales occurring after June 30, and will pay a royalty of 2.125% on all ex-U.S. sales occurring on or before December 28, 2014. PDL expects to recognize royalty revenue on the licensed products until Q1 2016. Additionally, the settlement terms provide for a better definition of revenues and audit inspection procedures related to the arbitration dispute filed by PDL. The settlement and the related agreement are conditional upon entry of a proposed order dismissing the underlying litigation and dismissal of the AAA arbitration filed by PDL.
News For PDLI;RHHBY From The Last 14 Days
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July 31, 2015
06:36 EDTRHHBYImmunoGen: enrollment in expansion cohort for IMGN853 to complete by year end
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July 30, 2015
09:25 EDTRHHBYLeerink life science tools analyst holds an analyst/industry conference call
Life Science Tools & Diagnostics Analyst Leonard, along with Dr. Anami Patel and Dr. Nathan Ledeboer, discuss their perspectives on Point-of-Care molecular tests including the opportunity in virology / microbiology, the threat to traditional lab-based testing and point-of-care instruments on an Analyst/Industry conference call to be held on July 30 at 11 am.
05:57 EDTRHHBYRoche submits filing to FDA for companion diagnostic for NSCLC drug therapy
Roche announced it has submitted the cobas EGFR Mutation Test v2 for Premarket Approval, or PMA, to the FDA, as a companion diagnostic test for AZD9291, an AstraZeneca (AZN) investigational therapy for non-small cell lung cancer patients with an acquired resistant mutation. Patients with non-small cell lung cancer who have adenocarcinoma with tumor containing an EGFR sensitizing mutation show significant benefit from currently available EGFR TKI therapies. However, approximately two-thirds of these patients will relapse and develop drug resistance. In many cases, this resistance is caused by an acquired mutation called T790M. The cobas EGFR v2 test can aid clinicians to appropriately select NSCLC patients who have acquired the T790M mutation and are most likely to benefit from AstraZeneca's novel therapy.
July 29, 2015
07:47 EDTPDLIARIAD to receive $200M through syntehtic-royalty financing with PDL BioPharma
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07:43 EDTPDLIARIAD to receive up to $200M through Iclusig synthetic-royalty financing with PDL BioPharma
ARIAD Pharmaceuticals (ARIA) announced that it will receive $100 million in cash – $50 million upon deal execution late yesterday and an additional $50 million in one year – through a synthetic-royalty financing from PDL BioPharma (PDLI) in exchange for paying PDL a mid-single-digit royalty on future sales of Iclusig until PDL receives a fixed internal rate of return. ARIAD also has an option, in its discretion, to receive up to an additional $100 million at any time between 6 and 12 months from the date of the agreement, in one or two tranches on comparable terms. ARIAD intends to use the base funds to conduct a front-line trial of brigatinib, its investigational ALK inhibitor, in patients with non-small cell lung cancer and to support brigatinib commercial readiness, as well as to continue its ongoing Iclusig initiatives. ARIAD is on track to complete enrollment in the pivotal ALTA trial of brigatinib in third quarter 2015, to file for approval in the U.S. next year, and subject to regulatory approval, to launch brigatinib by early 2017. Brigatinib has Breakthrough Designation from the U.S. Food and Drug Administration. “This financing allows us to accelerate initiation of the front-line trial of brigatinib and to ensure launch readiness as early as possible, while retaining strategic flexibility with respect to partnering and long-term commercialization of brigatinib,” said Harvey J. Berger, M.D., chairman and CEO of ARIAD. “We are confident based on the latest clinical data on brigatinib and other ALK‐inhibitors, that brigatinib may be an important new cancer medicine for patients with ALK+ lung cancer. With the funding provided by this royalty transaction, we expect to start the front-line trial by early next year, ahead of our expected filing for initial marketing approval of brigatinib in patients with refractory ALK+ NSCLC.”
July 28, 2015
07:08 EDTRHHBYRoche introduced several diagnostic testing platforms at the AACC 2015
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July 23, 2015
06:27 EDTRHHBYRoche CEO expects biosimilars in Europe by late 2017, Reuters reports
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05:46 EDTRHHBYRoche expects FY15 sales to grow low- mid-single digits
Expects FY15 core EPS to grow ahead of sales at constant exchange rates. Roche expects to further increase dividend in Swiss francs.
05:45 EDTRHHBYRoche reports 1H15 core EPS CHF 7.22 vs. 7.57 last year
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July 21, 2015
07:05 EDTRHHBYOphthotech names Shima as Chief Scientific Officer, Bjarke as CCO
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