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Biopharma News

FDA committee recommends approval of Mylan and Biocon's proposed biosimilar trastuzumab

FDA committee recommends approval of Mylan and Biocon's proposed biosimilar trastuzumab

16 Jul 2017

Vote marks first proposed biosimilar trastuzumab to be recommended by the committee.

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FDA approves Blincyto to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia

FDA approves Blincyto to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia

12 Jul 2017

Blincyto is the first and only Bispecific T cell Engager (BiTE) immunotherapy to demonstrate superior overall survival versus standard of care chemotherapy.

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Sanofi to acquire Protein Sciences

Sanofi to acquire Protein Sciences

11 Jul 2017

Acquisition adds recombinant-based influenza vaccine to Sanofi Pasteur's portfolio.

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BIOCAD’s rituximab biosimilar to receive MA in India

BIOCAD’s rituximab biosimilar to receive MA in India

4 Jul 2017

First shipment of BIOCAD’s Acellbia to India is scheduled for September 2017.

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FDA approves Vectibix for use in wild-type RAS metastatic colorectal cancer

FDA approves Vectibix for use in wild-type RAS metastatic colorectal cancer

2 Jul 2017

First-and-only fully human monoclonal anti-epidermal growth factor receptor antibody approved by the FDA for this patient population.

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Biogen’s Imraldi, an adalimumab biosimilar candidate referencing Humira, granted positive opinion by CHMP

Biogen’s Imraldi, an adalimumab biosimilar candidate referencing Humira, granted positive opinion by CHMP

23 Jun 2017

If approved, Imraldi will be the third anti-TNF biosimilar in Biogen’s portfolio in Europe.

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FDA accepts Amgen's sBLA to expand indication for Xgeva to include multiple myeloma patients

FDA accepts Amgen's sBLA to expand indication for Xgeva to include multiple myeloma patients

19 Jun 2017

Xgeva is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumours and is the number one prescribed agent by oncologists for this indication in the US.

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Sandoz receives approval in Europe for Rixathon to treat blood cancers and immunological diseases

Sandoz receives approval in Europe for Rixathon to treat blood cancers and immunological diseases

19 Jun 2017

Sandoz now has four biosimilars approved in Europe - more than any other company.

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FDA Advisory Committee to review Avastin biosimilar candidate

FDA Advisory Committee to review Avastin biosimilar candidate

7 Jun 2017

The Committee will review analytical, pharmacokinetic and clinical data from studies involving ABP 215, including results from a Phase III study in patients with NSCLC.

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Sartorius Stedim Biotech launches ambr 15 bioreactor system with Nova BioProfile FLEX2 integration

Sartorius Stedim Biotech launches ambr 15 bioreactor system with Nova BioProfile FLEX2 integration

5 Jun 2017

QbD studies in upstream processing more rapidly performed.

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Sandoz proposed biosimilars adalimumab and infliximab accepted for regulatory review by the EMA

Sandoz proposed biosimilars adalimumab and infliximab accepted for regulatory review by the EMA

31 May 2017

Biosimilar infliximab alone could potentially save the NHS £89 million.

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Boehringer Ingelheim inaugurates biopharmaceutical manufacturing facility in China

Boehringer Ingelheim inaugurates biopharmaceutical manufacturing facility in China

22 May 2017

It is the first and only biopharmaceutical manufacturing site established by a multinational active pharmaceutical company in China.

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