Latest News in the pharma Industry

Policy & Regulation

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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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 ...

Read more 
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.

Read more 
FDA grants Genentech’s cancer immunotherapy atezolizumab Priority Review for advanced bladder cancer

FDA grants Genentech’s cancer immunotherapy atezolizumab Priority Review for advanced bladder cancer

15 Mar 2016

FDA will make a decision on approval by 12 September 2016.

Read more 
FDA approves Xalkori for the treatment of patients with ROS1-positive metastatic NSCLC

FDA approves Xalkori for the treatment of patients with ROS1-positive metastatic NSCLC

13 Mar 2016

Xalkori is the first and only FDA-approved biomarker-driven therapy for ROS1-positive metastatic NSCLC.

Read more