IMAPAC news
Expanding on their long-standing macrocyclic peptide discovery alliance between the two companies since 2012, Japan-based PeptiDream announced last week that their proprietary Peptide Discovery Platform System (PDPS) technology will be used to identify novel macrocyclic/constrained peptides as PDCs against multiple targets of interest selected by Novartis.
Under the agreement, Novartis will have exclusive rights to the program peptides for radionuclide payloads/conjugates and certain
FDA announced the provision of final guidance on “interchangeable” biologics on 10th May 2019, aiming to promote competition in the biologics market. The document will provide clarity for biological product developers on whether they meet the criteria for statutory interchangeability standard under the Public Health Service Act (PHS Act).
The final guidance provides an overview and scientific recommendations required for licensing an application or supplement as an inte
In partnership with Mesoblast Limited, JCR Pharmaceuticals has filed to extend the marketing approval of TEMCELL, a mesenchymal stem cell (MSC) wound healing product for patients with Epidermolysis Bullosa (EB).
JCR has received an orphan drug designation for subcutaneous treatment of TEMCELL for EB, and are currently seeking a label extension for intravenous delivery of TEMCELL in Japan. There is no cure for EB in the current market, but MSC therapy using TEMCELL has shown promisi
Keytruda or pembrolizumab, MSD’s (Merck in USA/Canada) monotherapy for metastatic small cell lung cancer (SCLC) has been granted accelerated approval by FDA. Keytruda is now indicated for metastatic SCLC with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy.
This is the latest in the list of approved indications for use in SCLC, which has historically been a disease that has poor prognosis and limited treatment options
Researchers from Boston Children’s Hospital and MIT took mini-antibodies from alpacas Bryson and Sanchez. Then they shrunk the mini-antibodies into even smaller nanobodies and engineered these nanobodies onto CAR-T cells. During this process, they discovered a new form of cell therapy.
The goal is to enhance CAR-T cells’ targeting abilities by targeting immunosuppressive proteins in the tumour microenvironment. Using the idea that nanobodies have this targeting ability,