Latest News in the pharma Industry

Policy & Regulation

Janssen receives CHMP Positive Opinion for Trevicta recommending approval in EU for maintenance treatment of schizophrenia

Janssen receives CHMP Positive Opinion for Trevicta recommending approval in EU for maintenance treatment of schizophrenia

3 Apr 2016

If approved, Trevica will be the first treatment for schizophrenia to be administered four times a year and will provide the longest dosing interval available for an antipsychotic medication in the EU.

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OPKO receives Complete Response Letter from FDA for Rayaldee NDA

OPKO receives Complete Response Letter from FDA for Rayaldee NDA

3 Apr 2016

Sole issue relates to third-party manufacturing observations.

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Flixabi, an infliximab biosimilar candidate referencing Remicade, receives positive CHMP opinion

Flixabi, an infliximab biosimilar candidate referencing Remicade, receives positive CHMP opinion

2 Apr 2016

Flixabi to be the second anti-TNF biosimilar commercialized and manufactured by Biogen in the EU.

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EMA Validates BMS application for Opdivo for the treatment of classical Hodgkin lymphoma patients

EMA Validates BMS application for Opdivo for the treatment of classical Hodgkin lymphoma patients

31 Mar 2016

Opdivo has potential to become first PD-1 inhibitor approved in a hematological malignancy in European Union.

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SIR-Spheres Y-90 resin microspheres are a well-tolerated alternative to standard therapies for inoperable primary liver cancer, says new UK NICE MIB

SIR-Spheres Y-90 resin microspheres are a well-tolerated alternative to standard therapies for inoperable primary liver cancer, says new UK NICE MIB

31 Mar 2016

Unlike TACE, most patients treated with SIR-Spheres Y-90 resin microspheres usually require only a single treatment.

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Shire wins patent trial against Watson concerning Lialda

Shire wins patent trial against Watson concerning Lialda

29 Mar 2016

Lialda patent upheld and extends through 8 June 2020.

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Takeda and Lundbeck receive Complete Response Letter for Brintellix (vortioxetine) sNDA

Takeda and Lundbeck receive Complete Response Letter for Brintellix (vortioxetine) sNDA

29 Mar 2016

Lack of clinical trial data to support a claim of effectiveness for Brintellix in treating certain aspects of cognitive dysfunction in adults with MDD.

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EMA accepts for review Pfizer's MAA for Xeljanz for the treatment of moderate to severe rheumatoid arthritis

EMA accepts for review Pfizer's MAA for Xeljanz for the treatment of moderate to severe rheumatoid arthritis

28 Mar 2016

Application provides additional information to the original MAA submission, including data from the Phase III ORAL global development program in RA.

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FDA approves Teva's Cinqair (reslizumab) Injection

FDA approves Teva's Cinqair (reslizumab) Injection

24 Mar 2016

New biologic for add-on maintenance treatment in adults with severe asthma and an eosinophilic phenotype.

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Eisai withdraws NDA for mecobalamin ultra-high dose preparation as treatment for ALS

Eisai withdraws NDA for mecobalamin ultra-high dose preparation as treatment for ALS

24 Mar 2016

The application package submitted was not sufficient for approval.

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Akers Biosciences allowed US Patent for heparin/PF4 antibody detection

Akers Biosciences allowed US Patent for heparin/PF4 antibody detection

23 Mar 2016

The newly allowed Patent covers Akers Bio's proprietary protein preparation which serves as the antigen and biologically active component of the tests.

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Lilly's Taltz receives FDA approval for the treatment of moderate-to-severe plaque psoriasis

Lilly's Taltz receives FDA approval for the treatment of moderate-to-severe plaque psoriasis

23 Mar 2016

In pivotal studies, most patients treated with Taltz achieved significant skin clearance with many achieving virtually clear or completely clear skin at week 12.

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