Latest News in the pharma Industry

Policy & Regulation

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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Eagle Pharmaceuticals receives Complete Response Letter from FDA on Kangio application

Eagle Pharmaceuticals receives Complete Response Letter from FDA on Kangio application

20 Mar 2016

FDA requests further characterization of bivalirudin-related substances in the drug product.

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RedHill Biopharma announces positive FDA meeting on RHB-105 path to approval and planned confirmatory Phase III study for H. pylori infection

RedHill Biopharma announces positive FDA meeting on RHB-105 path to approval and planned confirmatory Phase III study for H. pylori infection

18 Apr 2016

The FDA has confirmed, subject to final minutes of the meeting, the planned two-arm, randomized, double-blind, active comparator design of the confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection, expected to be initiated ...

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Allergan confirms generic Abraxane patent challenge

Allergan confirms generic Abraxane patent challenge

17 Mar 2016

The company believes it is a "first applicant" to file an ANDA for the generic version of Abraxane.

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