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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, Boehringer tout new IPF analyses to boost their rival medications

The idiopathic pulmonary fibrosis market-share battle between Roche’s Esbriet and Boehringer Ingelheim’s Ofev hasn’t let up since the FDA green-lighted the medications in October, 2014. And this week, both drugmakers upped the ante with positive new data for their contenders.

Bron: FiercePharma 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 »

Roche’s lung cancer drug beats Pfizer rival in study

Roche has announced that its drug Alecensa (alectinib) succeeded in meeting its primary endpoint in a Phase 3 trial assessing its efficacy as a first-line treatment of anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer.

Bron: 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 »

Roche MS drug Ocrevus approved by FDA after three-month delay

The U.S. Food and Drug Administration (FDA) on Tuesday approved Roche Holding AG’s multiple sclerosis (MS) drug Ocrevus, putting the potential blockbuster drug back on track after a delay by regulators over manufacturing issues. The injectable drug, known chemically as ocrelizumab becomes the first U.S. approved medicine for primary progressive form of the neurological disease (PPMS).

Bron: Reuters 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 »

Roche’s Herceptin one step closer to biosim battle with Mylan licensing deal

Mylan and partner Biocon cleared another hurdle with their version of Roche’s breast cancer med Herceptin, one of the biggest biosim targets in the market. To wrap up their patent dispute, Roche will grant the partners a global license to its blockbuster drug in return for Mylan’s promise to back off of two challenges pending […]

Bron: FiercePharma Meer lezen »

Roche’s neoadjuvant breast cancer combo therapy shows strong Phase 3 results

Roche’s combination treatment of Perjeta (pertuzumab), Herceptin (trasdtuzumab) and chemotherapy met its primary endpoint in a recent Phase 3 study, improving invasive disease-free survival (iDFS) in those with HER2-positive early breast cancer (eBC) when administered post-surgery compared to Herceptin and chemotherapy alone.

Bron: Meer lezen »

Roche and Discuva extend agreement to develop target antimicrobials

Discuva, a drug discovery company based in Cambridge, UK, has announced that its collaboration with Roche, first agreed in 2014, has been extended until February 2018. The collaboration sees Discuva provide Roche with potential lead programmes that target Gram-negative pathogenic bacteria.  

Bron: Meer lezen »

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