RegulationApprovalsOncology October 18, 2022 Gilead’s Kite gets EC approval for Yescarta to treat DLBCL and HGBL By vbandhakavi The approval was granted based on data obtained from the pivotal Phase III ZUMA-7 study, which is said to be the largest and longest trial of a Chimeric
Drug Delivery October 17, 2022 Bavarian Nordic to supply smallpox and monkeypox vaccine to Switzerland By PBR Staff Writer Under the terms of the deal, the company will be responsible for the supply of 100,000 doses of the vaccine. The company will seek regulatory approval of the
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
RegulationApprovals October 7, 2022 FDA approves label expansion of Alnylam’s Oxlumo for PH1 By PBR Staff Writer Oxlumo, which is administered through subcutaneous injection, has now been indicated to treat PH1 to reduce the levels of urinary oxalate (UOx) and plasma oxalate (POx) in paediatric
Drug DiscoveryResearch & Development October 6, 2022 Eiger shuns plans to seek EUA from US FDA for Covid-19 treatment By PBR Staff Writer The decision to not submit the EUA application was made after receiving feedback from the FDA. Last month, the company submitted a request to FDA for a pre-EUA