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Drug and Device Firms Paid $3.5B to Care Providers

September 30, 2014 6:45 pm | by Ricardo Alonso-zaldivar - Associated Press - Associated Press | News | Comments

From research grants to travel junkets, drug and medical device companies paid doctors and leading hospitals billions of dollars last year, the government disclosed Tuesday in a new effort to spotlight potential ethical conflicts in medicine.  

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)...

Genentech Submits Supplemental Biologics License Application to FDA for Lucentis Indication in Diabetic Retinopathy

August 8, 2014 11:39 am | News | Comments

The submission is based on results of the RISE and RIDE Phase III clinical trials demonstrating...

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...

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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.  

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.        

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FDA Approves Xolair for Chronic Idiopathic Urticaria

March 24, 2014 8:25 am | News | Comments

The FDA has approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), a form of chronic hives. The new use is for patients 12 years of age and older who remain symptomatic despite treatment with H1-antihistamine therapy.

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.       

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.

FDA Strengthens Warnings for Arzerra and Rituxan

September 26, 2013 8:41 am | News | Comments

The FDA has approved changes to the prescribing information of the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab) to add new Boxed Warning information about the risk of reactivation of hepatitis B virus (HBV) infection.

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.

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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.

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.

FDA Grants Genentech’s Perjeta Regimen Priority Review

July 2, 2013 7:57 am | News | Comments

Genentech, a member of the Roche Group, today announced that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) for the use of a Perjeta® (pertuzumab) regimen before surgery (neoadjuvant treatment) in people with HER2-positive early stage breast cancer.

Two Studies Challenge Avastin’s Effectiveness Against a Rare Brain Cancer

June 3, 2013 8:21 am | by By ANDREW POLLACK | News | Comments

Two new studies have found that the widely used cancer drug Avastin does not prolong the lives of patients with a deadly form of brain cancer, raising questions about the role of the drug in treating that disease. The results could lead the Food and Drug Administration to revoke Avastin’s approval for the treatment of the brain cancer, called glioblastoma, much as it did with the drug’s approval for breast cancer.

FDA Approves Two Drugs, Companion Diagnostic Test for Advanced Skin Cancer

May 29, 2013 3:30 pm | News | Comments

The U.S. Food and Drug Administration today approved two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with advanced (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.

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FDA Warns of New Fake Batch of Cancer Drug Avastin

February 7, 2013 8:19 am | News | Comments

The Food and Drug Administration is warning U.S. doctors about another counterfeit version of the cancer drug Avastin, the third case involving the best-selling Roche drug in the past year. The FDA said in an online post Tuesday that at least one batch of the drug distributed by a New York company does not contain the active ingredient in real Avastin.

FDA Approves New Use of Avastin Plus Chemotherapy for People with Metastatic Colorectal Cancer

January 24, 2013 2:58 am | News | Comments

Genentech, a member of the Roche Group has announced that the U.S. Food and Drug Administration (FDA) has approved a new use of Avastin ® (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people with metastatic colorectal cancer (mCRC).

FDA OKs Lucentis for Diabetes-Related Eye Disorder

August 13, 2012 4:01 am | News | Comments

WASHINGTON (AP) — The FDA on Friday approved Roche's injectable eye drug Lucentis for a new use in treating a diabetes-related condition that can cause blindness.  

HHS Secretary Sebelius Announces Public-Private Partnerships to Fight HIV and AIDS

July 23, 2012 4:11 am | News | Comments

In a speech at the opening session of the XIX International AIDS Conference (AIDS 2012), Health and Human Services (HHS) Secretary Kathleen Sebelius announced a series of innovative public-private partnerships in the fight against the HIV/AIDS epidemic.

ImmunoGen, Genentech Cancer Drug Meets Study Goal

April 2, 2012 4:15 am | News | Comments

NEW YORK (AP) — ImmunoGen Inc. and Genentech say that their experimental breast cancer treatment, which combines the drug Herceptin with a cell-killing agent, worked in a late-stage clinical trial.  

Studies: Avastin May Fight Early Breast Cancers

January 26, 2012 3:09 am | by MARILYNN MARCHIONE,AP Chief Medical Writer | News | Comments

Surprising results from two new studies may reopen debate about the value of Avastin for breast cancer. The drug helped make tumors disappear in certain women with early-stage disease, researchers found.

Constellation Pharmaceuticals and Genentech Enter Broad Epigenetics Drug Discovery Collaboration

January 17, 2012 3:16 am | News | Comments

Constellation Pharmaceuticals, Inc., today announced that it has entered into a major strategic agreement with Genentech, a member of the Roche Group, to launch a broad collaboration based on the science of epigenetics and chromatin biology to discover and develop innovative treatments for cancer and other serious diseases.

Xenon to Collaborate with Genentech on Discovery of Novel Targeted Pain Therapeutics

January 9, 2012 3:23 am | News | Comments

Xenon today announced a strategic alliance with Genentech, a member of the Roche Group, to discover and develop compounds and companion diagnostics for the potential treatment of pain.

Regeneron Announces Settlement of Patent Litigation with Genentech

January 3, 2012 3:27 am | News | Comments

Regeneron Pharmaceuticals, Inc. today announced that the company has entered into a non-exclusive license and partial settlement agreement with Genentech, Inc., a member of the Roche Group relating to U.S. ophthalmic sales of EYLEAT (aflibercept) Injection.

FDA Revokes Approval of Avastin for Breast Cancer

November 21, 2011 3:27 am | by LAURAN NEERGAARD,AP Medical Writer | News | Comments

WASHINGTON (AP) — The government delivered a blow to some desperate patients Friday as it ruled the blockbuster drug Avastin should no longer be used to treat advanced breast cancer.

Genentech Submits NDA for Rare Form of Advanced Skin Cancer

September 12, 2011 4:22 am | News | Comments

Genentech, a member of the Roche Group, today announced that the company has submitted a New Drug Application for vismodegib to the FDA for the treatment of people with advanced basal cell carcinoma (BCC) for whom surgery is considered inappropriate.

Concentration Lowered in Tamiflu Medication

July 13, 2011 10:12 am | News | Comments

When flu season arrives this fall, a liquid form of Tamiflu—the most widely used anti-viral flu medication—will be available in a new, lower concentration to reduce the possibility of medication errors.  

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