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FDA Grants Genentech’s Cobimetinib Priority Review for Use in Combination with Zelboraf in Advanced Melanoma

February 19, 2015 8:18 am | News | Comments

Genentech, a member of the Roche Group, announced the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company’s New Drug Application (NDA) for cobimetinib in combination with Zelboraf ® (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma

FDA Approves Genentech’s Lucentis® for Treatment of Diabetic Retinopathy in People With Diabetic Macular Edema

February 9, 2015 7:12 am | News | Comments

Genentech, a member of the Roche Group announced that the FDA approved Lucentis® for the...

Roche, Meiji and Fedora to Collaborate on New Antibiotic to Fight Increasing Bacterial Resistance

January 13, 2015 11:26 am | News | Comments

Roche, Meiji Seika Pharma and Fedora have entered into a license agreement for the development...

Roche Takes Majority Stake in Foundation Medicine for $1.03B

January 12, 2015 8:23 am | News | Comments

Roche is taking a majority stake in U.S.-based Foundation Medicine in a deal worth $1.03 billion...

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Roche Enters Genomic Informatics Market with Bina Technologies Acquisition

December 22, 2014 9:00 am | News | Comments

Roche has announced the acquisition of Bina Technologies, a privately held company based in Redwood City, California, USA. Bina provides a big data platform for centralized management and processing of next generation sequencing (NGS) data.  

Drugmakers Bet on Ebola Vaccines, Treatments

October 26, 2014 9:33 am | by Matthew Perrone - Associated Press - Associated Press | News | Comments

Drugmakers are racing to develop vaccines and drugs to address the worst outbreak of Ebola in history. It's unclear who will pay for their products, but companies are betting that governments and aid groups will foot the bill.    

NewLink Genetics Rises on Roche Cancer Partnership

October 20, 2014 2:59 pm | News | Comments

NewLink said it will get $150M upfront from Genentech, and could receive more than $1B in payments based on milestones, as well as royalties if the drug is approved. The drug, now called NLG919, is in early-stage clinical testing.    

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FDA Approves Esbriet to Treat Idiopathic Pulmonary Fibrosis

October 16, 2014 8:41 am | News | Comments

Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities.  

Roche Posts Flat Nine-Month Sales

October 16, 2014 8:14 am | by JOHN HEILPRIN, Associated Press | News | Comments

Roche Holding AG posted flat sales for the first nine months of 2014, but said Thursday the results show strong demand for its cancer drugs and emerging new products.              

FDA Grants Priority Review for Genentech’s Lucentis in Diabetic Retinopathy

October 8, 2014 3:35 pm | News | Comments

Genentech announced that the FDA has accepted to file the company's supplemental Biologics License Application and granted Priority Review of Lucentis® for the treatment of diabetic retinopathy, an eye disease that impacts nearly 7.7 million Americans. The FDA confirmed action date is February 6, 2015.

Roche Ranked Most Sustainable Healthcare Company in the Dow Jones Sustainability Indices

September 11, 2014 11:25 am | News | Comments

For the sixth consecutive year, Roche has been recognized by the Dow Jones Sustainability Indices (DJSI) as the Group Leader in sustainability within the pharmaceuticals, biotechnology and life sciences industry. This places Roche amongst the top 10 percent of companies across all surveyed industries.

Roche to Buy InterMune for $8.3B

August 25, 2014 8:10 am | News | Comments

Roche said Sunday it has reached an $8.3 billion deal to buy InterMune Inc., a California-based developer of treatments for lung diseases.                   

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FDA Approves Genentech’s Avastin Plus Chemotherapy for Treatment of Advanced Cervical Cancer

August 15, 2014 8:23 am | News | Comments

Genentech, a member of the Roche Group, announced that the FDA approved Avastin® (bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of women with persistent, recurrent or metastatic carcinoma of the cervix.

AstraZeneca and Roche to Develop Companion Diagnostic Test for AZD9291

July 28, 2014 7:57 am | News | Comments

AstraZeneca today announced it has entered into collaboration with Roche to develop a plasma-based companion diagnostic test to support AZD9291, AstraZeneca’s investigational compound in clinical development for non-small-cell lung cancer (NSCLC).

Roche Posts Seven Percent Profit Drop

July 24, 2014 2:29 am | by The Associated Press | News | Comments

Swiss drugmaker Roche Holding AG on Thursday posted a net profit drop of 7 percent compared with a year ago, weighed down by a strong Swiss franc and charges from one of its diagnostic units.          

FDA Grants Genentech’s Avastin Priority Review for Recurrent Platinum-Resistant Ovarian Cancer

July 22, 2014 8:13 am | News | Comments

Genentech, a member of the Roche Group, today announced that the FDA has accepted the company's supplemental Biologics License Application and granted Priority Review for Avastin® plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer.

Genentech Alzheimer's Drug Misses Goals in Studies

July 16, 2014 1:45 pm | by MARILYNN MARCHIONE, AP Chief Medical Writer | News | Comments

An experimental drug from Genentech failed to slow mental decline in mid-stage studies on more than 500 people with mild to moderate Alzheimer's disease, but showed some promise in the least-impaired participants who received a higher dose.  

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FDA Grants Roche’s Avastin Priority Review for Certain Types of Cervical Cancer

July 15, 2014 8:38 am | News | Comments

Roche announced that the 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 the treatment of women with persistent, recurrent or metastatic cervical cancer.

Genentech’s Investigational Medicine Cobimetinib, Used in Combination with Zelboraf® Meets Phase III Endpoint

July 14, 2014 8:24 am | News | Comments

The study demonstrated that the investigational MEK inhibitor cobimetinib, used in combination with Genentech’s BRAF inhibitor Zelboraf, helped patients with previously untreated BRAF V600 mutation-positive advanced melanoma live significantly longer without their disease worsening.

Roche Buying Seragon in U.S. for Up to $1.7B

July 2, 2014 4:29 am | by The Associated Press | News | Comments

Roche Holding AG says its U.S.-based biotech company Genentech has agreed to acquire American biotechnology firm Seragon Pharmaceuticals, Inc. for up to $1.725 billion in cash and contingency payments.        

Roche Acquires Genia Technologies

June 2, 2014 8:34 am | News | Comments

Roche announced today the acquisition of Genia Technologies, Inc., a privately held company, based in Mountain View, California, USA. Genia is developing a single-molecule, semiconductor based, DNA sequencing platform using nanopore technology.

Italy Seeks $1.6B in Damages from Novartis and Roche

May 29, 2014 1:45 pm | News | Comments

Italy's health ministry is seeking 1.2 billion euros ($1.63 billion) in damages from Swiss pharmaceutical giants Novartis and Roche after an anti-trust court ruled the two companies colluded to prevent the distribution of an eye medication.  

FDA Approves First HPV Test for Primary Cervical Cancer Screening

April 25, 2014 8:26 am | News | Comments

The FDA has approved the first FDA-approved HPV DNA test for women 25 and older that can be used alone to help a health care professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer.    

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 recommended unanimously that the benefits of the cobas HPV (Human Papillomavirus) Test as a first-line primary screening tool in women 25 years and older to assess their risk of cervical cancer based on the presence of clinically relevant high-risk HPV DNA outweigh the risks.

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 Hematology-Oncology Division at Vanderbilt University Medical Center in the US, will join Roche Pharma Research and Early Development (pRED) as Global Head of the Oncology Disease and Translational Area.

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 committee has recommended that the Phase III METLung study be stopped due to a lack of clinically meaningful efficacy.       

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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