Latest News in the pharma Industry

Policy & Regulation

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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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.

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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.

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EMA reviews cancer medicine Zydelig

EMA reviews cancer medicine Zydelig

13 Mar 2016

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

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FDA issues a draft guidance for industry on Implementation of the ‘Deemed to be a License’ Provision of the BPCI Act of 2009

FDA issues a draft guidance for industry on Implementation of the ‘Deemed to be a License’ Provision of the BPCI Act of 2009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The draft guidance explains that FDA will not approve any pending or tentatively approved application for a biological product under the FD&C Act after 23 March 2020.

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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.

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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.

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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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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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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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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 .

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