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FDA Rejects Lilly’s Eczema Treatment Over Third-Party Manufacturing Issues

BioSpace

Eli Lilly’s Biologic License Application for its monoclonal antibody lebrikizumab was denied by the regulator after issues were found at a third-party contract manufacturing organization.

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Lipidor signs cooperation agreement with contract manufacturer to offer licensees the opportunity for GMP production

The Pharma Data

Under the agreement, Aurena Laboratories will establish a production unit to meet the regulatory requirements for the manufacture of Lipidor’s pharmaceutical products. This is an important step towards a licensing agreement for Lipidor drug candidates, AKP01 and AKP02, for the treatment of psoriasis.

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Symbiosis Pharmaceutical Services granted MHRA license following £1 million investment

BioPharma Reporter

Symbiosis Pharmaceutical Services can now test small molecule, biological and advanced therapeutical medicinal products (ATMP) following a Â1 million investment.

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SpectronRx Receives U.S. Nuclear Regulatory Commission Materials License for New Facility

pharmaphorum

SpectronRx , a leading radiopharmaceutical contract development and manufacturing organization (CDMO), announced today that the U.S. Nuclear Regulatory Commission (NRC) has issued a Materials License for its new Indianapolis, IN headquarters. Nuclear Regulatory Commission Materials License for New Facility appeared first on.

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Abiogen acquires EffRx to fortify bone disease portfolio

Pharmaceutical Technology

The company’s last deal included an exclusive license agreement with the Cardiff, UK-headquartered specialty pharmaceuticals company Diurnal group for the commercialisation of Efmody (hydrocortisone) in Switzerland. Separate from drug development, the Italian company also offers contract manufacturing and clinical supply services.

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ADCs Pipeline Update: Avacta Partners with ADC Therapeutics

Roots Analysis

Currently, product licensing agreements, technology licensing agreements, research and development agreements and clinical trial agreements are the common types of partnerships inked by developers that are currently focused on the development of ADCs pipeline.

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Subcutaneous Medications and Drug Delivery Systems

Roots Analysis

In fact, the share of biologics in the overall pharmaceutical contract manufacturing market has increased from 16% in 2006 to over 25% in 2017. Biologics constitute a majority of the top selling drugs and represent one of the fastest growing segments of the overall pharmaceutical industry.