Latest News in the pharma Industry

Research & Development

FDA accepts sBLA for Keytruda (pembrolizumab) in advanced NSCLC

FDA accepts sBLA for Keytruda (pembrolizumab) in advanced NSCLC

7 Mar 2016

Application based on data from KEYNOTE-010, which showed superior overall survival for patients taking Keytruda compared to chemotherapy in patients with PD-L1 expression on one percent or more of the cancer cells.

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Adding Spiriva Respimat effective for uncontrolled asthma, regardless of allergy subtype

Adding Spiriva Respimat effective for uncontrolled asthma, regardless of allergy subtype

7 Mar 2016

Spiriva Respimat shown effective in the broad range of asthma patients studied who continued to experience symptoms despite taking other asthma maintenance therapies.

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Imbruvica (ibrutinib) approved by FDA for the first-line treatment of chronic lymphocytic leukemia

Imbruvica (ibrutinib) approved by FDA for the first-line treatment of chronic lymphocytic leukemia

7 Mar 2016

First FDA-approved chemotherapy-free treatment option for first-line CLL patients.

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DSMB recommends Celldex's Phase III study of Rintega (rindopepimut) in newly diagnosed glioblastoma be discontinued

DSMB recommends Celldex's Phase III study of Rintega (rindopepimut) in newly diagnosed glioblastoma be discontinued

7 Mar 2016

Study unlikely to meet primary overall survival endpoint in patients with minimal residual disease.

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Victoza significantly reduces the risk of major adverse cardiovascular events in the LEADER trial

Victoza significantly reduces the risk of major adverse cardiovascular events in the LEADER trial

6 Mar 2016

The safety profile of Victoza in LEADER was generally consistent with previous liraglutide clinical studies.

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Ixekizumab demonstrates rapid, improvements as among patients with moderate-to-severe plaque psoriasis

Ixekizumab demonstrates rapid, improvements as among patients with moderate-to-severe plaque psoriasis

6 Mar 2016

In a combined analysis of UNCOVER-2 and UNCOVER-3, significant improvement of psoriasis plaques was observed in patients treated with ixekizumab at 1, 2 and 4 weeks.

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Onconova Therapeutics receives notice of termination for convenience from Baxalta

Onconova Therapeutics receives notice of termination for convenience from Baxalta

4 Mar 2016

Rights to commercialize rigosertib in Europe to revert to Onconova.

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FDA approves new indication for Faslodex (fulvestrant)

FDA approves new indication for Faslodex (fulvestrant)

3 Mar 2016

Approval expands use and offers additional option for women with HR+, HER2- metastatic breast cancer.

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Breast cancer is only pharmaceutical pipeline with over 1000 drugs in development

Breast cancer is only pharmaceutical pipeline with over 1000 drugs in development

3 Mar 2016

GBI Research says the pipeline may significantly alter the clinical and commercial landscape of the disease market over the next decade.

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Merck initiates Phase III study of MSB11022, a proposed biosimilar of adalimumab, in chronic plaque psoriasis

Merck initiates Phase III study of MSB11022, a proposed biosimilar of adalimumab, in chronic plaque psoriasis

2 Mar 2016

Study will evaluate efficacy, safety and immunogenicity of adalimumab biosimilar candidate MSB11022 compared with Humira.

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Concert Pharmaceuticals announces CTP-656 solid dose Phase I results confirmed superior pharmacokinetic profile to Kalydeco

Concert Pharmaceuticals announces CTP-656 solid dose Phase I results confirmed superior pharmacokinetic profile to Kalydeco

2 Mar 2016

Concert is using this tablet formulation of CTP-656 in its ongoing multiple ascending dose Phase I clinical trial and intends to use the same formulation in a Phase II clinical trial.

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Sobi and Biogen receive positive opinion from CHMP for Alprolix (rFIXFc) for the treatment of hemophilia B

Sobi and Biogen receive positive opinion from CHMP for Alprolix (rFIXFc) for the treatment of hemophilia B

2 Mar 2016

If approved, Alprolix would be among the first therapies in the European Union (EU) to offer people living with hemophilia B prolonged protection against bleeding episodes with prophylactic dosing intervals.

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