All articles by Vidya Sagar Maddela

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