Latest News in the pharma Industry

Policy & Regulation

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FDA issues a draft guidance for industry on Implementation of the ‘Deemed to be a License’ Provision of the BPCI Act of 2009

FDA issues a draft guidance for industry on Implementation of the ‘Deemed to be a License’ Provision of the BPCI Act of 2009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The draft guidance explains that FDA will not approve any pending or tentatively approved application for a biological product under the FD&C Act after 23 March 2020.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

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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.

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True North Therapeutics receives Orphan Drug Designation in the EU for TNT009 for the treatment of autoimmune hemolytic anemia, including CAD

True North Therapeutics receives Orphan Drug Designation in the EU for TNT009 for the treatment of autoimmune hemolytic anemia, including CAD

29 Feb 2016

Top-line Phase Ib data in patients with CAD expected in mid-2016.

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FDA approves new indication for Novartis drug Afinitor for progressive, nonfunctional GI and lung neuroendocrine tumours

FDA approves new indication for Novartis drug Afinitor for progressive, nonfunctional GI and lung neuroendocrine tumours

28 Feb 2016

In advanced progressive, nonfunctional NET, Afinitor is the first approved treatment for patients with lung NET and the first oral therapy for GI NET.

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