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Biopharma News

Patheon signs flexible manufacturing agreement with Amgen

Patheon signs flexible manufacturing agreement with Amgen

14 Mar 2016

Patheon has developed unique solutions and business models providing flexible manufacturing options for clients to address the complex client needs in a changing landscape.

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FDA issues a draft guidance for industry on Implementation of the ‘Deemed to be a License’ Provision of the BPCI Act of 2009

FDA issues a draft guidance for industry on Implementation of the ‘Deemed to be a License’ Provision of the BPCI Act of 2009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The draft guidance explains that FDA will not approve any pending or tentatively approved application for a biological product under the FD&C Act after 23 March 2020.

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Peregrine Pharmaceuticals announces formal commissioning of new, state-of-the-art commercial manufacturing facility

Peregrine Pharmaceuticals announces formal commissioning of new, state-of-the-art commercial manufacturing facility

9 Mar 2016

Facility being operated by Avid Bioservices subsidiary with capacity to potentially generate additional $40 million in annual revenue.

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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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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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World’s second biggest influenza vaccine manufacturer expands operations at Speke site

World’s second biggest influenza vaccine manufacturer expands operations at Speke site

25 Feb 2016

£22 million investment in Liverpool by global biopharma company.

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Irvine Scientific launches new feed media to maximize productivity in large-scale bioproduction

Irvine Scientific launches new feed media to maximize productivity in large-scale bioproduction

24 Feb 2016

BalanCD CHO Feed 4 is a chemically-defined, animal component-free powder feed for large-scale bioproduction in a variety of high performing CHO cells.

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Sartocon Slice 50: Sartorius Stedim Biotech presents a new small-scale crossflow device

Sartocon Slice 50: Sartorius Stedim Biotech presents a new small-scale crossflow device

17 Feb 2016

Designed for use in biotechnological applications, especially for membrane screening and small-volume process development.

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US biotechs driving growth at Scottish CMO

US biotechs driving growth at Scottish CMO

16 Feb 2016

Symbiosis Pharmaceutical Services has picked-up several new clients in North America, which has primarily been driven by companies looking for small-scale aseptic manufacturing capabilities to support clinical trials.

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JHL Biotech receives approval From European authorities to begin biosimilar clinical trial

JHL Biotech receives approval From European authorities to begin biosimilar clinical trial

15 Feb 2016

First biotech company in Greater China region to receive European approval.

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Sandoz strengthens its biosimilars portfolio with acquisition of Pfizer's biosimilar infliximab in EEA

Sandoz strengthens its biosimilars portfolio with acquisition of Pfizer's biosimilar infliximab in EEA

12 Feb 2016

Deal strengthens Novartis immunology portfolio which includes investigational biosimilars adalimumab, etanercept and rituximab.

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Pfizer commends FDA Advisory Committee’s vote to approve proposed biosimilar infliximab

Pfizer commends FDA Advisory Committee’s vote to approve proposed biosimilar infliximab

10 Feb 2016

The first biosimilar monoclonal antibody reviewed, for all eligible indications.

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