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The Lead

DNA Alternative to Pap Smear Sparks Medical Debate

April 15, 2014 1:41 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

A high-tech screening tool for cervical cancer is facing pushback from more than a dozen U.S. patient groups, who warn that the genetic test could displace a simpler, cheaper and more established mainstay of women's health: the Pap smear.  

FDA Committee Recommends Roche's HPV Test for Detection of Cervical Cancer

March 13, 2014 8:27 am | News | Comments

Roche has announced FDA Microbiology Devices Panel of the Medical Devices Advisory Committee...

Roche Names New Head of Oncology Research

March 6, 2014 1:52 pm | News | Comments

Roche announced today that William Pao, M.D., Ph.D., Professor of Medicine and Head of the...

Genentech Ends Phase III Lung Cancer Study

March 3, 2014 8:40 am | News | Comments

Genentech, a member of the Roche Group, announced today that an independent data monitoring...

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Pharma Data Play Larger Role in Olympic Drug Tests

February 10, 2014 8:34 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

Some of the world's biggest drugmakers are playing a larger role in anti-doping efforts at this year's Winter Olympics: They're providing information on drugs that once would have been considered proprietary trade secrets.     

PDL Biopharma Settles Roche Royalty Fight

February 4, 2014 8:24 am | News | Comments

PDL Biopharma has agreed to settle its disputes with Swiss drugmaker Roche over royalty rates on a group of drugs PDL helped develop. The dispute concerned four cancer drugs: Avastin, Herceptin, Kadcyla, and Perjeta; also involved were the asthma treatment Xolair, and Lucentis, an eye drug.

Advancing Clinical Science Through Data Sharing

February 3, 2014 8:54 am | Videos | Comments

In response to advances in technology and the increasing needs of society, Roche has implemented a broader data sharing policy. The company's new policy provides access to summary data in the form of clinical study reports (CSRs), and analyzable patient level data sets

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Roche Reports Strong Profit, Expects Growth in 2014

January 30, 2014 8:14 am | by JOHN HEILPRIN, Associated Press | News | Comments

Strong demand for its cancer medicines and diagnostic tests used by clinical laboratories boosted Swiss drug maker Roche's full-year profits, the company reported Thursday.             

Prothena to Receive $30M Upfront Payment from Roche

January 23, 2014 9:33 am | News | Comments

Prothena Corporation announced today that, pursuant to its License, Development, and Commercialization Agreement with Roche, it will receive the $30 million upfront payment from Roche as a result of the License Agreement having become effective upon the expiration of the Hart-Scott-Rodino waiting period.

Roche Provides Update on the First Two of Six Phase III Schizophrenia Studies

January 21, 2014 8:48 am | News | Comments

Roche today announced that two phase III studies of its investigational medicine bitopertin (RG1678) in adults with persistent, predominant negative symptoms of schizophrenia failed to meet their primary endpoints.      

Roche and Prothena to Devlop Antibodies for Parkinson's Disease

December 11, 2013 4:13 pm | News | Comments

Roche and Prothena Corporation have entered into a worldwide collaboration to develop and commercialize antibodies that target alpha-synuclein, including PRX002, Prothena's monoclonal antibody for the treatment of Parkinson's disease, which is currently in preclinical development and is expected to enter Phase 1 clinical trials in patients with Parkinson's disease in 2014.

Roche and Molecular Partners to Develop New Cancer Treatments

December 4, 2013 8:47 am | News | Comments

Roche and Molecular Partners AG today announced that they have entered into a research collaboration and licensing agreement to discover, develop and commercialize several proprietary therapeutics incorporating Molecular Partners’ DARPin ® biologics conjugated to toxic agents developed at Roche for the treatment of cancer.

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Swiss Reject Plan to Cap Managers' Pay

November 25, 2013 8:09 am | by GEIR MOULSON, Associated Press | News | Comments

Swiss voters soundly rejected on Sunday a proposal to limit the pay of companies' highest-paid managers to 12 times that of their lowest-paid workers. Switzerland is home to global business players such as pharmaceutical companies Novartis and Roche; insurance groups Zurich and Swiss Re; and banks UBS and Credit Suisse.

EU Regulator: No More Problems with Roche Drugs

November 19, 2013 9:04 am | News | Comments

The European Medicines Agency says it has finished an investigation of the way pharmaceutical giant Roche reported side effects for 19 drugs in the U.S. and has found no new safety concerns.          

Roche and immatics Sign Cancer Vaccine and Immunotherapy Collaboration

November 13, 2013 8:35 am | News | Comments

The agreement will focus on the research, clinical development and commercialization of a number of new tumour-associated peptide (TUMAP)-based cancer vaccine candidates and other immunotherapies in oncology, targeting primarily gastric, prostate and non-small cell lung cancer.

Polyphor and Roche Join Efforts to Combat Multidrug-Resistant Bacterial Infections

November 4, 2013 8:20 am | News | Comments

Polyphor Ltd, a privately held pharmaceutical company, and Roche announced today that they have entered into an exclusive worldwide license agreement to develop and commercialize Polyphor’s investigational macrocycle antibiotic, POL7080, for patients suffering from bacterial infections caused by Pseudomonas aeruginosa.

Amgen Acquires Filgrastim Franchise Rights from Roche In 100 Markets

October 22, 2013 9:15 am | News | Comments

Amgen today announced that it has entered into a definitive agreement with F. Hoffmann-La Roche to acquire Roche's rights to filgrastim and pegfilgrastim in approximately 100 markets, effective Jan. 1, 2014.     

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Roche: Six Percent Sales Boost in First Nine Months

October 17, 2013 8:13 am | by JOHN HEILPRIN, Associated Press | News | Comments

Roche Holding AG has reported a 6 percent increase in overall sales for the first nine months of the year helped by strong demand for its established and new cancer drugs. The Basel, Switzerland-based company said that its group sales over three quarters rose to 34.9 billion Swiss francs ($38.2 billion), up from 33.7 billion francs in the same time period last year.

Roche to Invest 800M Swiss Francs in Global Biologic Medicine Manufacturing Network

October 14, 2013 8:01 am | News | Comments

Roche today announced plans to invest 800 million Swiss francs within its global manufacturing network to increase production capabilities for its biologic medicines over the next five years. The investment will be spread across sites in Penzberg (Germany), Basel (Switzerland), as well as Vacaville and Oceanside (USA).

FDA Files Genentech’s Supplemental BLS of Xolair® for Chronic Idiopathic Urticaria (CIU)

October 11, 2013 8:04 am | News | Comments

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has accepted and filed the company’s supplemental Biologics License Application (sBLA) for subcutaneous use of Xolair ® (omalizumab) in people with Chronic Idiopathic Urticaria (CIU) who remained symptomatic despite treatment with H 1 -antihistamine therapy at approved doses.

Roche to Tap Lufthansa CEO as New Board Chairman

September 16, 2013 8:37 am | News | Comments

Swiss drugmaker Roche said Friday it is tapping Lufthansa CEO Christoph Franz to serve as its next board chairman. The company, based in Basel, Switzerland, said that Franz would be nominated to succeed the current board chairman, Franz Humer, in a vote at the annual shareholders' meeting in early March.

FDA Panel Backs Roche Drug for Early Stage Breast Cancer

September 13, 2013 7:59 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

A biotech drug from Roche moved one step closer to becoming the first medicine approved to treat breast cancer before surgery. The FDA 's panel of cancer experts voted 13-0, with one abstention, that the benefits of Perjeta as an initial treatment for breast cancer outweigh its risks.

FDA: Roche Drug Works in Early-Stage Breast Cancer

September 11, 2013 8:16 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

The FDA has issued a positive review of a breast cancer drug from Roche that could soon become the first pharmaceutical option approved for treating early-stage disease before surgery. In documents posted online, FDA scientists said women who received the drug Perjeta as initial treatment for breast cancer were more likely to be cancer-free at the time of surgery than women who received older drug combinations.

Roche, Inovio Plan Partnership to Develop Vaccines

September 10, 2013 8:13 am | by The Associated Press | News | Comments

Inovio Pharmaceuticals Inc. could earn more than $400 million through a partnership with Swiss drugmaker Roche Holding AG to develop potential vaccines that target prostate cancer and hepatitis B.         

Roche’s New Formulation of Herceptin Approved in Europe

September 3, 2013 8:58 am | News | Comments

Roche has announced that a new injectable (subcutaneous) formulation of Herceptin (trastuzumab) has been approved by the European Commission for the treatment of HER2-positive breast cancer, an aggressive sub-type of the disease. The approval is for both early and later stages of treatment.

Roche Blockbuster Sales Boost First-Half Profits

July 25, 2013 9:37 am | News | Comments

Roche Holding AG posted an 11 percent rise in first-half profit Thursday boosted by strong sales of its blockbuster cancer drugs.                     

Alexion Rockets on Roche Buyout Speculation

July 14, 2013 6:14 pm | News | Comments

Shares of Alexion Pharmaceuticals Inc. jumped Friday on media reports that Swiss drugmaker Roche is considering a buyout of the smaller Connecticut-based drugmaker.                

Roche Halts Diabetes Drug Development after Safety Review

July 10, 2013 8:45 am | News | Comments

Roche today announced that following the results of a regular safety review of the aleglitazar AleCardio phase III trial, the independent Data and Safety Monitoring Board (DSMB) has recommended to halt the trial due to safety signals and lack of efficacy.

FDA Grants Genentech’s Obinutuzumab Priority Review

July 3, 2013 8:03 am | News | Comments

Genentech has announced that the FDA has accepted the company's Biologics License Application (BLA) for obinutuzumab (GA101) and granted Priority Review for GA101 in the treatment of chronic lymphocytic leukemia (CLL), one of the most common forms of blood cancer.

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