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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