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

pharmaphorum

Indiana-based radiopharmaceutical Contract Development and Manufacturing Organization expands nuclear pharmacy capabilities with second location . SpectronRx , a leading radiopharmaceutical contract development and manufacturing organization (CDMO), announced today that the U.S. To learn more, visit SpectronRx.com.

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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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BioSig abandons COVID-19 drug trial on safety concerns

pharmaphorum

Things were looking promising for the project as recently as last month, when BioSig said it was doubling the size of the study from 40 to 80 patients and hiring a contract manufacturer to produce supplies for a phase 3 trials programme. BioSig has previously said it was considering a spin-out of ViralClear.

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Bayer joins the COVID-19 vaccine push, backing CureVac shot

pharmaphorum

The biotech would likely struggle to supply without the help of its new big pharma partner, although it has been expanding its production capacity in the last few weeks with the help of contract manufacturers like Wacker and Fareva.