FDA Grants Genentech’s Cobimetinib Priority Review for Use in Combination with Zelboraf in Advanced MelanomaFebruary 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 EdemaFebruary 9, 2015 7:12 am | News | Comments
Genentech, a member of the Roche Group announced that the FDA approved Lucentis® for the...
Genentech, a member of the Roche Group has announced that the U.S. Food and Drug Administration...
NewLink said it will get $150M upfront from Genentech, and could receive more than $1B in...
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.
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.
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.
Genentech Submits Supplemental Biologics License Application to FDA for Lucentis Indication in Diabetic RetinopathyAugust 8, 2014 11:39 am | News | Comments
The 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. There are currently no ocular medications approved for the treatment of diabetic retinopathy.
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.
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 EndpointJuly 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 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.
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, 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.
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.
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.
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.
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 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.
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.
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.
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).
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.
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.
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.
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, 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 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 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.
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