Latest News in the pharma Industry

Policy & Regulation

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 
EMA reviews cancer medicine Zydelig

EMA reviews cancer medicine Zydelig

13 Mar 2016

Review follows concerns over serious adverse events in ongoing clinical trials.

Read more 
FDA issues a draft guidance for industry on Implementation of the ‘Deemed to be a License’ Provision of the BPCI Act of 2009

FDA issues a draft guidance for industry on Implementation of the ‘Deemed to be a License’ Provision of the BPCI Act of 2009

11 Mar 2016

The draft guidance explains that FDA will not approve any pending or tentatively approved application for a biological product under the FD&C Act after 23 March 2020.

Read more 
Allergan Receives Complete Response Letter from FDA for Prior Approval Supplement for Restasis 0.05% Multi-Dose Preservative-Free bottle

Allergan Receives Complete Response Letter from FDA for Prior Approval Supplement for Restasis 0.05% Multi-Dose Preservative-Free bottle

10 Mar 2016

FDA requested additional CMC information for the Multi-Dose Preservative-Free bottle.

Read more 
EMA launches PRIME — paving the way for promising medicines for patients

EMA launches PRIME — paving the way for promising medicines for patients

8 Mar 2016

New scheme supports European Commission priorities.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
Sartorius Stedim BioOutsource contract testing facility in Glasgow successfully passes FDA inspection

Sartorius Stedim BioOutsource contract testing facility in Glasgow successfully passes FDA inspection

2 Mar 2016

Certified quality of analytical services for developers of biologics and biosimilars .

Read more 
Amgen submits sBLA for Blincyto (blinatumomab)

Amgen submits sBLA for Blincyto (blinatumomab)

2 Mar 2016

Filing based on Phase II study showing Blincyto provides meaningful therapeutic benefits in difficult-to-treat type of pediatric acute lymphoblastic leukemia.

Read more 
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.

Read more