Research & Development October 26, 2022 Normunity raises funds to develop immuno-oncology therapies By PBR Staff Writer Led by Canaan Ventures, the financing round has seen participation from Taiho Ventures, Osage University Partners, and Sanofi Ventures. Normunity intends to use the funds for advancing its
Drug DiscoveryResearch & Development October 25, 2022 FDA grants priority review for Daiichi Sankyo’s AML medicine By PBR Staff Writer The regulator has accepted the company’ new drug application (NDA) for the combination therapy and as continuation of quizartinib monotherapy after consolidation to treat FLT3-ITD–positive AML patients. Quizartinib,
RegulationDrug Filing October 24, 2022 ARS Pharma’s NDA accepted for neffy to treat allergic reactions of Type I By PBR Staff Writer If approved by the regulatory agency, neffy would be the first non-injectable treatment available to patients suffering with allergic reactions of Type I, including anaphylaxis. The regulatory body has
Oncology October 21, 2022 Kite, Refuge sign license deal for gene expression platform for blood cancers By PBR Staff Writer The platform of Refuge is a synthetic biology system leveraging an expression modulation strategy to repress or activate transcription of target genes. Early pre-clinical data indicate a potential
RegulationApprovals October 17, 2022 EMA’s CHMP recommends approval for Novartis’ prostate cancer therapy By PBR Staff Writer The regulator has recommended the radioligand therapy along with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition to treat progressive PSMA- positive mCRPC adult
News October 14, 2022 AdAlta, GPCR Therapeutics partner on new cancer treatment approach By PBR Staff Writer The companies will assess AdAlta’s CXCR4 inhibiting i-bodies as cancer therapeutics, using GPCR’s combination inhibition technique. AdAlta owns an i-bodies panel that inhibit CXCR4 signalling in different ways.
RegulationApprovals October 13, 2022 SiSaf to seek FDA Orphan Drug Designation for SIS-101-ADO By PBR Staff Writer The company is seeking regulatory approval for SIS-101-ADO to treat Autosomal Dominant Osteopetrosis Type 2 (ADO2) patients. CSSi LifeSciences will be responsible for coordinating the regulatory process that
RegulationApprovals October 12, 2022 Eligo’s EB003 receives FDA Orphan Drug Designation and RPD designation By PBR Staff Writer The CRISPR-based gene therapy has been indicated to treat Shiga-toxin producing bacterial infection to prevent hemolytic uremic syndrome (HUS). It has been designed to target Shiga toxins from
RegulationApprovals October 11, 2022 China’s NMPA approves sNDA for JW Therapeutics’ follicular lymphoma therapy By PBR Staff Writer The injection (abbreviated as relma-cel ) has been approved to treat adult patients with follicular lymphoma that relapses or is refractory in 24 months of second-line or above
RegulationApprovals October 10, 2022 China approves Innovent sNDA for hepatocellular carcinoma treatment By PBR Staff Writer Discovered and developed by Lilly, Cyramza has been approved for the treatment of HCC patients with an alpha fetoprotein of ≥400 ng/mL and who have received treatment with