Archives for April 5, 2018

KBI, ReForm partnership about ‘bringing better biologics to patients,’ says CEO

KBI will provide services to ReForm to further develop and validate its biologic formulation platform and in turn, will gain access to ReForm’s proprietary excipient technologies.

Transparency on trial: How to navigate FDAAA 801 final rule implementation and compliance

Regulations are changing across the globe as patients, the scientific community, and other stakeholders call for increased clinical trial data transparency.

UPDATE

Plant issues plague Celltrion and Teva as FDA issues two biosimilars CRLs

The US FDA has issued complete response letters (CRL) for the Rituxan and Herceptin biosimilar candidates after Celltrion’s facility received a warning in Janaury.

Lilly to develop encapsulated diabetes cell therapies through Sigilon deal

Eli Lilly has licensed Sigilon Therapeutics’ technology to develop encapsulated cell therapies for the treatment of type 1 diabetes.