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Immuno-oncology upset in bladder cancer

  Roche and Genentech’s checkpoint inhibitor atezolizumab did not improve overall survival in a confirmatory phase III trial in patients with advanced bladder cancer. The FDA granted accelerated approval to the anti-programmed cell death protein 1 ligand 1 (PDL1) antibody for this indication in 2016

Bron: Nature Reviews Drug Discovery Meer lezen »

Roche’s Tecentriq wins FDA approval for treating advanced bladder cancer

Genentech, a unit of Swiss drugmaker Roche Holding AG, said on Monday it got approval from the U.S. Food and Drug Administration for its already approved immunotherapy drug, Tecentriq, to treat advanced bladder cancer.

Bron: Reuters Meer lezen »

Cardio-, Cerebrovascular Safety of Ranibizumab in DME Evaluated

Findings from a pooled analysis published in JAMA Ophthalmology suggest that intravitreous ranibizumab does not increase the risk of systemic vascular events for patients with diabetic macular edema (DME). DME patients have a higher risk of vascular complications such as stroke and myocardial infarction (MI).

Bron: Monthly Prescribing Reference (MPR): Drug News Meer lezen »

First treatment for form of MS approved by FDA

In big news for sufferers of MS and the company that developed the drug, Roche subsidiary Genentech, the FDA has approved Ocrevus for primary progressive multiple sclerosis (PPMS) and relapsing forms of MS (RMS).  The treatment comes as the first new treatment for those suffering from the rare form of MS, PPMS.

Bron: Meer lezen »

Genentech plans second Phase 3 Alzheimer’s trial following endpoint failures

Genentech, Roche’s biotech group, has announced its plans to conduct a second Phase 3 study for crenezumab, its anti-Abeta antibody for the treatment of early Alzheimer’s disease. The trial is designed to further elucidate earlier traces data on the drug’s efficacy in treating Alzheimer’s.

Bron: Meer lezen »

Kite Pharma, Roche to co-develop two new treatments for NHL

Kite Pharma said it will collaborate with Swiss drug major Roche to evaluate the safety and efficacy of its drug compound in combination with KTE-C19, in combination with atezolizumab to treat non-Hodgkin lymphoma (NHL). The company said it expects to start multi-center Phase I/ II study with Genentech, a unit of Roche, in 2016.

Bron: Meer lezen »

Experts predict pharma sector to remain strong in 2016

The year 2016 is set to see continued growth in research and development productivity, with significant new drug launches and a limited impact of patent expiries, according to a new report. The report claims blockbuster drug launches will continue to set the tone in 2016, with a dozen therapies seeking FDA approval next year. Roche […]

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Roche lung cancer drug Alecensa gets rapid US approval

The US health watchdog has approved Alecensa, a drug for people with certain types of non-small cell lung cancer manufactured by Genentech, a subsidiary of the Swiss pharma giant Roche. The FDA granted accelerated approval for Alecensa (alectinib), for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who […]

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Roche lung cancer therapy succeeds in mid-stage trial

Roche’s biotech arm Genentech has scored positive results in a pivotal Phase II study of its investigational cancer immunotherapy atezolizumab. The treatment, which targets PD-L1 (Programmed Death Ligand-1) proteins on tumour cells, met its primary endpoint and shrank tumours in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumour expressed PD-L1. […]

Bron: Meer lezen »

Roche biotech unit submits skin cancer drug application to U.S. regulator

Genentech, U.S. biotech unit of Swiss drugmaker Roche holding, said on Monday it had filed a marketing application to U.S. regulators for the use of its experimental drug in combination with another medicine to treat an advanced form of skin cancer.

Bron: Reuters Meer lezen »

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