RegulationApprovals September 22, 2023 FDA approves Krystal Biotech’s KB408 for AATD treatment By PBR Staff Writer The company submitted the application in August this year seeking approval for the initiation of Phase I clinical trial of KB408. The regulator, after the 30-day review of
Production & Sales September 21, 2023 WuXi XDC opens new GMP facilities in China By PBR Staff Writer With an area of around 7,000m2, the new location features the XBCM2 dual-function facility for bioconjugate drug substance and antibody intermediates production. It also comprises the XDP2 facility,
Approvals September 20, 2023 ViiV Healthcare receives European Commission approval for Apretude By PBR Staff Writer Cabotegravir is indicated for use in high-risk adults and adolescents aged a minimum of 12 years weighing at least 35 kg. It is claimed to be the first
Immunology September 19, 2023 Kymera receives FDA fast track designation for KT-333 By PBR Staff Writer KT-333 is a highly selective degrader of STAT3, a transcriptional regulator that is linked to inflammatory and autoimmune diseases as well as various cancers. The company is also
ApprovalsOther Diseases September 18, 2023 UK’s NICE recommends QUVIVIQ to treat chronic insomnia in adults By PBR Staff Writer A Final Draft Guidance (FDG) has been issued for QUVIVIQ for the treatment of these patients with symptoms lasting for three nights or more per week for at
Drug Discovery September 15, 2023 Nona and BeiGene agree to expand antibody discovery partnership By PBR Staff Writer Through the collaboration, BeiGene can access Nona’s fully human transgenic mice platform, Harbour Mice. In 2018, BeiGene received the rights to leverage the Harbour Mice heavy chain (H2L2)
Drug DiscoveryResearch & Development September 14, 2023 Synaffix, ABL Bio partner to develop bispecific ADCs By PBR Staff Writer Under the agreement, Synaffix will be eligible for an upfront payment, milestone payments along with tiered royalties on net sales of resulting products. The company will also produce
Drug Discovery September 13, 2023 Salipro and Sumitomo Pharma sign partnership for drug discovery programme By PBR Staff Writer Under the partnership, the companies will reveal the drug candidate’s mechanism of action as well as pharmacological characterisation. Salipro Biotech CEO Jens Frauenfeld said: “We are excited to
Oncology September 12, 2023 Orano Med and Orbit partner for radionuclide therapies discovery By PBR Staff Writer As per the agreement terms, Orbit will discover peptide leads specific to targets related to certain tumours by deploying its bead-based peptide display engine. Orbit Discovery CEO Dr
RegulationOncology September 11, 2023 US FDA issues guidance for Citius’ lymphoma treatment BLA By PBR Staff Writer An engineered interleukin-2 (IL-2)-diphtheria toxin fusion protein, Lymphir is intended for relapsed or refractory CTCL patients following treatment with a minimum of one systemic therapy previously. As per