All articles by Vidya Sagar Maddela
DAAN Biotherapeutics partners with GC Cell for CAR-T and CAR-NK therapies
The licensing agreement allows GC Cell to use DAAN Biotherapeutics’ tumour antigen-specific antibody sequence for developing CAR-T and CAR-NK therapies to treat cancers
Viatris Files Supplemental New Drug Applications to Japan’s Ministry of Health, Labor and Welfare for the Approval of EFFEXOR for the Treatment of Generalized Anxiety Disorder
Aiming to address a significant unmet need for which no other approved treatment option is available for generalized anxiety disorder patients in Japan
Sanofi, Regeneron’s Dupixent granted FDA approval to treat CSU
The FDA approval was supported by data from two Phase 3 clinical trials, Study A and Study C, evaluating Dupixent as an add-on therapy to standard antihistamines in biologic-naïve patients aged 12 and older
Calidi secures FDA IND approval for CLD-201 in solid tumours
CLD-201 is an allogeneic stem cell-based immunotherapy that uses adipose tissue-derived stem cells combined with oncolytic vaccinia virus, poised to enter clinical development for treating solid tumours in adults
Tevogen Bio Finalizes Agreement for Company’s Own Cell Therapy Production Facility
The agreement formalizes a previously announced letter of intent. Specific details of the facility and related services, including scope of work, costs, and timelines, will be set out in one or more future work orders.
Neurelis secures FDA approval for Valtoco to treat seizure clusters
Valtoco is a unique formulation of diazepam that employs INTRAVAIL technology, which allows the non-invasive administration of a wide range of drugs, including proteins, peptides, and small molecules
Chime, Polpharma partner to advance biosimilar development
Under the partnership, Chime will support Polpharma Biologics, including the entire biosimilar development process from investigational new drug (IND) stage to commercial supply.
Eisai, Biogen’s Alzheimer’s drug Leqembi authorised in EU
Leqembi is indicated for adult patients with mild cognitive impairment (MCI) and mild dementia due to AD (early AD), who are non-carriers of apolipoprotein E ε4 (ApoE ε4)
Boehringer Ingelheim and Cue Biopharma collaborate on autoimmune therapy
The partnership aims to leverage Cue Biopharma’s unique approach to B cell depletion therapy, enhancing benefits and safety compared to existing treatments targeting B cells.
Intas acquires Neulasta biosimilar Udenyca from Coherus BioSciences
The acquisition includes assets related to the Udenyca franchise, including pre-filled syringes, autoinjectors, and on-body injectors, and certain liabilities