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...
Roche, Meiji Seika Pharma and Fedora have entered into a license agreement for the development...
Roche is taking a majority stake in U.S.-based Foundation Medicine in a deal worth $1.03 billion...
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 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 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.
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 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.
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.
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 said Sunday it has reached an $8.3 billion deal to buy InterMune Inc., a California-based developer of treatments for lung diseases.
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 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).
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.
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.
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 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.
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'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.
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.
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.
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 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, 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 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.
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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