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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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Pfizer’s pill cuts COVID deaths and hospitalisations by 90%

pharmaphorum

The company said it plans to adopt a tiered pricing approach to the drug depending on a country’s income, and is “exploring” contract manufacturing deals to for less well-off nations.

DNA 111
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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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Sourcing Blockbuster Oncology Products for Clinical Trial Supply

XTalks

Biosimilars are increasingly becoming the standard of care and both have several licensed biosimilar drugs (e.g. Clinical Services International is a trusted partner of leading pharmaceutical and biotechnology companies, contract research organisations, and contract manufacturing organisations.