16Jan/14

FDA to Evaluate Idelalisib for Indolent Non-Hodgkin's Lymphoma – Monthly Prescribing Reference

FDA to Evaluate Idelalisib for Indolent Non-Hodgkin’s Lymphoma
Monthly Prescribing Reference
The NDA submission was supported by a single arm Phase 2 study (Study 101-09) evaluating idelalisib in patients with iNHL that is refractory (non-responsive) to rituximab and to alkylating-agent-containing chemotherapy. Idelalisib is an investigational …
FDA Approves Application Review For Refractory Indolent Non-Hodgkin’s …BioResearch Online (press release)

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15Jan/14

Teva Pharmaceutical Industries Ltd (ADR) (TEVA): Teva Pharmaceutical … – Seeking Alpha

Teva Pharmaceutical Industries Ltd (ADR) (TEVA): Teva Pharmaceutical …
Seeking Alpha
Treanda, used for the treatment of patients with chronic lymphocytic leukemia (CLL) and patients with indolent B-cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing …

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15Jan/14

FDA sets standard review for Gilead's idelalisib in NHL – PMLiVE

FDA sets standard review for Gilead’s idelalisib in NHL
PMLiVE
The marketing application in NHL was filed last September on the back of a single phase II trial in patients whose disease had progressed despite treatment with Roche and Biogen Idec’s Rituxan (rituximab) or conventional chemotherapy. Idelalisib …
3 Reasons to Buy Gilead Sciences, Inc.Motley Fool
Standard Review for Gilead’s Oncology Candidate – Analyst BlogNASDAQ
Gilead’s Idelalisib NDA accepted by US FDA for the treatment of refractory …MENAFN.COM

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14Jan/14

3 Reasons to Buy Gilead Sciences, Inc. – Motley Fool

3 Reasons to Buy Gilead Sciences, Inc.
Motley Fool
Last December, Gilead announced that a late-stage trial for idelalisib was stopped early because patients receiving a combo of idelalisib plus rituximab showed a highly significant improvement in overall survival and progression-free survival. With the …
Standard Review for Gilead’s Oncology Candidate – Analyst BlogNASDAQ
Gilead’s Idelalisib NDA accepted by US FDA for the treatment of refractory …MENAFN.COM

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14Jan/14

Standard Review for Gileads Oncology Candidate – Zacks.com

Standard Review for Gileads Oncology Candidate
Zacks.com
The patients were refractory to both Roche’s (RHHBY) Rituxan (rituximab) and to chemotherapy inclusive alkylating-agent. A decision from the FDA is expected by Sep 11, 2014. Apart from iNHL, idelalisib is also being evaluated in other oncology …
Gilead’s Idelalisib NDA accepted by US FDA for the treatment of refractory …MENAFN.COM

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14Jan/14

Cell Therapeutics reaquire rights to two anti-cancer compounds from Novartis – pharmabiz.com


Drug Discovery & Development

Cell Therapeutics reaquire rights to two anti-cancer compounds from Novartis
pharmabiz.com
CTI is currently accruing patients into a phase III trial comparing Pixuvri and rituximab with gemcitabine and rituximab in the setting of aggressive B-cell NHL. Pixuvri does not have marketing approval in the United States. Opaxio (paclitaxel …
Cell Therapeutics Reveals Drug Portfolio Progress, Outlook For 2014 – UpdateNASDAQ
Cell Therapeutics Inc : Cell Therapeutics Announces 2014 Outlook and Recent …4-traders (press release)

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