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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...

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...

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-...

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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.

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.

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.  

Judge Denies Roche and Genentech's Motions to Dismiss PDL BioPharma's Complaint

July 11, 2011 5:10 am | News | Comments

PDL BioPharma, Inc. has announced that on July 7, 2011, the Second Judicial District Court of Nevada ruled in favor of PDL on two motions to dismiss filed by Genentech and F. Hoffmann LaRoche, Ltd. (Roche) in PDL's lawsuit related to the 2003 settlement agreement with Genentech.

FDA Approves Rituxan

April 20, 2011 4:47 am | News | Comments

Genentech, a member of the Roche Group and Biogen Idec announced today that the FDA has approved Rituxan(R) (rituximab), in combination with corticosteroids, as a new medicine for adults with Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA).

FDA OKs Rituxan as Cancer Maintenance Treatment

January 31, 2011 3:49 am | News | Comments

NEW YORK (AP) — Biogen Idec Inc. and Genentech said Friday that the FDA has approved an additional use for blockbuster cancer drug Rituxan as a first-line maintenance treatment for patients with follicular lymphoma, a cancer of the blood.

Melanoma Drug Meets Study Goal

January 19, 2011 3:49 am | News | Comments

Genentech said its cancer drug RG7204 improved survival for people with melanoma, and slowed the progress of the disease.

Genentech Issues Avastin Response; Requests FDA Hearing

December 17, 2010 3:59 am | News | Comments

Genentech issues a complete response letter regarding the recent Avastin ruling and will request a hearing with the FDA.

FDA Extends Review of Genentech's Avastin

September 20, 2010 4:58 am | News | Comments

NEW YORK (AP) — Genentech, a unit of Swiss drug developer Roche, said Friday that the FDA extended a review of Avastin as an initial breast cancer treatment. The agency will take an additional 90 days to review the application, citing the need to review new information submitted by the company.

Genentech Provides Update on FDA Application for T-DM1

August 27, 2010 4:36 am | News | Comments

Genentech, a member of the Roche Group has announced that the FDA issued a Refuse to File letter for accelerated approval for the company's trastuzumab-DM1 (T-DM1) Biologics License Application (BLA).

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