Key Developments: Roche Holding AG (ROG.VX)

ROG.VX on Virt-X Level 1

267.00CHF
25 Jul 2014
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Latest Key Developments (Source: Significant Developments)

Roche Holding AG reaffirms FY 2014 guidance - Conference Call
Thursday, 24 Jul 2014 07:00am EDT 

Roche Holding AG:Says it is confident to meet FY 2014 targets.Expects FY 2014 to grow sales at low to mid single-digit rates and core EPS ahead of sales.FY 2014 revenue of 47.219 billion swiss francs and 14.86 swiss francs - Thomson Reuters I/B/E/S.  Full Article

FDA grants Roche Holding AG's Genentech's Avastin priority review for recurrent platinum-resistant ovarian cancer
Tuesday, 22 Jul 2014 01:11am EDT 

Roche Holding AG:Genentech, a member of the Roche Group says that U.S. Food and Drug Administration (FDA) has accepted the company's supplemental biologics license application (sBLA).And granted priority review for Avastin (bevacizumab) plus chemotherapy for treatment of women with recurrent platinum-resistant ovarian cancer.Designation of priority review status is granted to medicines that FDA believes have potential to provide 'significant improvements in safety or effectiveness of treatment, diagnosis, or prevention of serious conditions when compared to standard applications.SBLA for Avastin plus chemotherapy for recurrent platinum-resistant ovarian cancer is based on data from Phase III AURELIA trial with FDA action date of Nov. 19.  Full Article

FDA Grants Roche Holding AG's Genentech's Avastin priority review for certain types of cervical cancer
Tuesday, 15 Jul 2014 01:00am EDT 

Roche Holding AG:Genentech, a member of Roche Holding AG, announced that U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA).And granted priority review for Avastin (bevacizumab) plus chemotherapy for treatment of women with persistent, recurrent or metastatic cervical cancer.Designation of priority review status is granted to medicines that FDA believes have potential to provide 'significant improvements in safety or effectiveness of treatment, diagnosis, or prevention of serious conditions when compared to standard applications.  Full Article

Roche Holding AG announces definitive agreement to acquire Seragon Pharmaceuticals
Wednesday, 2 Jul 2014 01:15am EDT 

Roche Holding AG:Says it has entered into a definitive agreement to acquire Seragon Pharmaceuticals, Inc. (Seragon), a privately held biotechnology company based in San Diego, California.With this acquisition, Genentech obtains rights to Seragon's entire portfolio of investigational oral selective estrogen receptor degraders (SERDs) for the potential treatment of hormone receptor-positive breast cancer.Under the terms of the agreement, Genentech will make an upfront cash payment of $725 million, plus additional contingent payments of up to $1 billion based on achievement of certain predetermined milestones.The transaction is expected to close in the third quarter of 2014.Says once the transaction is completed, Seragon's portfolio will be integrated into Genentech Research and Early Development.  Full Article

Roche Holding AG and Ferring Pharmaceuticals collaborate to develop personalised infertility treatment
Tuesday, 24 Jun 2014 04:00am EDT 

Roche Holding AG and Ferring Pharmaceuticals:Announced a collaboration to combine diagnostic testing technology from Roche with Ferring's human cell line derived recombinant follicle-stimulating hormone (human rFSH), a gonadotrophin currently in phase III development.Roche will work with Ferring and its global phase III programme to qualify, validate, document and seek regulatory approval for a companion diagnostic test to be used in combination with Ferring's human rFSH.  Full Article

Roche Holding AG receives EU approval for new subcutaneous formulation of RoACTEMRA
Sunday, 27 Apr 2014 08:00pm EDT 

Roche Holding AG:Announces that subcutaneous formulation of RoACTEMRA (tocilizumab) has received approval from European Commission for treatment of moderate to severe rheumatoid arthritis (RA) in patients who are either intolerant to or have failed to respond to other RA treatments.This approval makes RoACTEMRA first anti IL-6 receptor biologic available as subcutaneous and intravenous (IV) formulations for both monotherapy and combination therapy with methotrexate (MTX).It is the fourth update to RoACTEMRA’s European label and significantly expands number of patients who have access to RoACTEMRA.Approval was based on data from phase III SUMMACTA and BREVACTA studies.SUMMACTA showed that efficacy and tolerability of subcutaneous RoACTEMRA was comparable with intravenous RoACTEMRA.In addition, subcutaneous RoACTEMRA demonstrated long-term efficacy and reduced progression of joint damage over 48 weeks compared to placebo in the BREVACTA study.Subcutaneous formulation of RoACTEMRA to be available via prefilled syringe.It was approved in Japan and United States in 2013.  Full Article

Fitch affirms Roche Holding AG at AA- Dow Jones
Wednesday, 16 Apr 2014 11:25am EDT 

Roche Holding AG:Fitch Ratings affirms Roche Holding Ltd's (Roche) Long-term Issuer Default Rating (IDR) and senior unsecured rating at AA - Dow Jones.Outlook on long-term IDR is stable.Short-term IDR has been affirmed at F1+.  Full Article

Roche Holding AG confirms FY 2014 outlook
Monday, 14 Apr 2014 08:00pm EDT 

Roche Holding AG:Confirms full FY 2014 outlook.Expects low-to mid-single digit growth in group sales at constant exchange rates in FY 2014.Says core EPS is targeted to grow ahead of sales in FY 2014.FY 2013 sales of 46,780 million Swiss francs.FY 2014 revenue estimate 47,706 million Swiss francs - Thomson Reuters I/B/E/S.  Full Article

France's competition authority investigates Roche Holding AG in relation to eye disease treatments - Reuters
Wednesday, 9 Apr 2014 08:00pm EDT 

Roche Holding AG:France's competition authority is investigating Roche and Novartis on suspicion they were involved in anti-competitive practices in relation to eye disease treatments - Reuters.This is second time in as many months that Swiss drugmakers have faced regulatory scrutiny over treatments for wet age-related macular degeneration (AMD)- cause of blindness among elderly.Last month, prosecutors in Rome opened investigation into four executives at Swiss drugmakers on suspicion of fraud and manipulation of pharmaceutical market, according to judicial sources.Earlier in March, Italy's antitrust authority said Roche and Novartis colluded to try to stop cancer drug Avastin from being used to treat AMD and fined companies 182.5 million euros ($254.2 million).Regulator accused firms of striking alliance to prevent distribution of Roche's Avastin in favour of the more expensive drug Lucentis made by Novartis.  Full Article

Roche Holding AG acquires IQuum Inc
Monday, 7 Apr 2014 01:01am EDT 

Roche Holding AG:Announces acquisition of IQuum, Inc. (IQuum) based in Marlborough, Massachusetts, USA.IQuum is privately held company focused on developing point of care offerings for molecular diagnostics market.Under terms of agreement, Roche to pay IQuum shareholders $275 million upfront and up to $175 million in contingent product related milestones.Acquisition to provide Roche with access to IQuum’s Laboratory-in-a-tube (Liat) System, which enables healthcare workers to perform rapid molecular diagnostic testing in a point of care setting, closer to patients and with minimal training.The Liat Analyzer and Liat Influenza A/B Assay, first test available for use on system, produce reliable and accurate lab-like results and are CE marked and FDA cleared.Once transaction is complete, IQuum to be integrated into Roche Molecular Diagnostics.  Full Article

AstraZeneca taps Roche, Qiagen for new blood-based cancer drug tests

LONDON, July 28 - AstraZeneca has signed up Roche and Qiagen to develop two separate diagnostic tests, both using simple blood samples, to identify patients who will benefit from its lung cancer drugs.

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