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Biopharma News

Quintiles launches suite of services to integrate asset development planning

Quintiles launches suite of services to integrate asset development planning

14 Dec 2015

New offering incorporates clinical, commercial and regulatory insight to improve the probability of an asset’s commercial success.

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ImmBio initiates First-in-Human studies of its novel pneumococcal vaccine, PnuBioVax

ImmBio initiates First-in-Human studies of its novel pneumococcal vaccine, PnuBioVax

11 Dec 2015

The PnuBioVax vaccine contains heat shock proteins and multiple antigens produced by a modified form of S. pneumoniae, leading to a mechanism of action which is expected to be strain-independent.

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AstraZeneca to harness power of the Secretome and develop next-generation biologics in collaboration with new WCPR

AstraZeneca to harness power of the Secretome and develop next-generation biologics in collaboration with new WCPR

11 Dec 2015

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Merck Announces Samsung Bioepis receives approval of Renfelxis (infliximab), a biosimilar of Remicade, in Korea

Merck Announces Samsung Bioepis receives approval of Renfelxis (infliximab), a biosimilar of Remicade, in Korea

7 Dec 2015

Samsung Bioepis’ second immunology biosimilar approved, to be commercialized under partnership with Merck

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Bespak addresses India’s biopharmaceutical drive for high value drug delivery products that differentiate generics, biobetters and biosimilars at CPhI India 2015

Bespak addresses India’s biopharmaceutical drive for high value drug delivery products that differentiate generics, biobetters and biosimilars at CPhI India 2015

3 Dec 2015

The company showcases the innovative Syrina 2.25 auto-injector that brings the flexibility to design a unique form factor and also the full Syrina platform accommodating multiple primary containers and high viscous, high volume injections.

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Novozymes' Veltis half-life extension technology embraced by Paras Biopharmaceuticals to develop new biobetter

Novozymes' Veltis half-life extension technology embraced by Paras Biopharmaceuticals to develop new biobetter

30 Nov 2015

Paras Biopharmaceuticals partners with Novozymes in a feasibility study using Veltis technology to develop an improved version of a leading osteoporosis treatment.

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Amgen's first biosimilar Biologics License Application for ABP 501 submitted To FDA

Amgen's first biosimilar Biologics License Application for ABP 501 submitted To FDA

26 Nov 2015

Supported by Phase III studies in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis.

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Catalent Biologics expands analytical and process development capabilities

Catalent Biologics expands analytical and process development capabilities

20 Nov 2015

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FDA accepts for priority review the sBLA for Opdivo in patients with advanced renal cell carcinoma

FDA accepts for priority review the sBLA for Opdivo in patients with advanced renal cell carcinoma

17 Nov 2015

The projected FDA action date is 16 March 2016.

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Aptar Stelmi to feature PremiumCoat  at CPHI India

Aptar Stelmi to feature PremiumCoat at CPHI India

17 Nov 2015

Coated stoppers for sensitive and high-value injectables.

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Amgen presents detailed results from Phase III study demonstrating clinical equivalence of biosimilar candidate ABP 501 with adalimumab

Amgen presents detailed results from Phase III study demonstrating clinical equivalence of biosimilar candidate ABP 501 with adalimumab

12 Nov 2015

First completed Phase III study of adalimumab biosimilar in the treatment of patients with moderate-to-severe RA.

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New ambr 15 fermentation micro-scale bioreactor system provides enhanced microbial strain screening

New ambr 15 fermentation micro-scale bioreactor system provides enhanced microbial strain screening

3 Nov 2015

The system offers parallel processing and walk-away control of 24 micro bioreactors.

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