Key Developments: Roche Holding AG (ROG.VX)

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Latest Key Developments (Source: Significant Developments)

Roche Holding AG says FDA approves Avastin plus chemotherapy for platinum-resistant recurrent ovarian cancer
Friday, 15 Aug 2014 01:00am EDT 

Roche Holding AG:Says FDA approves Avastin plus chemotherapy for platinum-resistant recurrent ovarian cancer.  Full Article

Roche Holding AG's Genentech receives FDA approval for Avastin Plus Chemotherapy
Thursday, 14 Aug 2014 03:52pm EDT 

Roche Holding AG:Says Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration approved Avastin in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of women with persistent, recurrent or metastatic carcinoma of the cervix.  Full Article

Roche Holding AG's Genentech submits supplemental biologics license application to FDA for lucentis indication in diabetic retinopathy
Friday, 8 Aug 2014 11:00am EDT 

Roche Holding AG:Says its Genentech, announced that the company has submitted a supplemental Biologics License Application (sBLA) for Lucentis (ranibizumab injection) to the U.S. Food and Drug Administration (FDA) for the treatment of diabetic retinopathy.Submission is based on results of the RISE and RIDE Phase III clinical trials demonstrating the safety and efficacy of Lucentis for this serious eye disease.Diabetic retinopathy is the most common diabetic eye disease, impacting nearly 7.7 million Americans.  Full Article

EU approves Roche Holding AG’s Avastin for platinum-resistant recurrent ovarian cancer
Wednesday, 6 Aug 2014 01:00am EDT 

Roche Holding AG:Says EU approves Roche’s Avastin for platinum-resistant recurrent ovarian cancer.Approval based on results of phase III AURELIA study which involved women with recurrent, platinum-resistant ovarian cancer who received either chemotherapy or Avastin in combination with chemotherapy.  Full Article

Roche Holding AG to acquire Santaris Pharma to expand discovery and development of RNA-targeting medicines
Sunday, 3 Aug 2014 08:00pm EDT 

Roche Holding AG:Says to acquire Santaris Pharma to expand discovery and development of RNA-targeting medicines.Says acquisition is expected to close in Aug. 2014.Plans to maintain Santaris Pharma’s operations in Denmark, where existing site to be renamed Roche Innovation Center Copenhagen.Says under terms of agreement, Roche to make upfront cash payment of $250 million to Santaris Pharma shareholders and make additional contingent payments of up to $200 million based on achievement of certain predetermined milestones.  Full Article

Roche Holding AG receives EU approval for Gazyvaro
Tuesday, 29 Jul 2014 01:00am EDT 

Roche Holding AG:Says Gazyvaro approved in Europe for patients with most common type of leukemia.Approval is based on phase III CLL11 study.  Full Article

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 EPS of 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

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Shares in Japan's Chugai surge on report of Roche buyout offer

TOKYO - Shares in Japan's Chugai Pharmaceutical Co Ltd jumped 15 percent on Monday on a media report that its 60-percent shareholder, Roche Holding AG , was in talks to buy the rest of the company for about $10 billion.

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