article thumbnail

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.

article thumbnail

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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.

article thumbnail

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.

article thumbnail

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.

article thumbnail

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 116
article thumbnail

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.