All articles by Vidya Sagar Maddela
Vidya Sagar Maddela
EC approves Roche’s Itovebi-based regimen to treat breast cancer
The EC approval is based on the Phase 3 INAVO120 trial, a randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of the Itovebi combination.
Bayer’s Nubeqa plus ADT granted EC approval to treat mHSPC
Nubeqa plus ADT is indicated for the treatment of people with metastatic hormone-sensitive prostate cancer (mHSPC) in the European Union (EU).
Biogen invests $2bn in North Carolina’s Research Triangle Park
The investment will focus on expanding antisense oligonucleotide (ASO) capabilities and establishing clinical and commercial multi-platform fill finish capabilities.
ARS Pharma secures UK MHRA approval for EURneffy nasal spray
EURneffy is the first needle-free emergency treatment option approved for allergic reactions, including anaphylaxis, in adults and children over 30kg.
SpringWorks secures EC conditional authorisation for Ezmekly
Ezmekly, also known as Gomekli in the US, is an oral, small-molecule MEK inhibitor indicated for plexiform neurofibromas (PN) with neurofibromatosis type 1 (NF1).
US FDA approves GSK’s Shingrix vaccine in prefilled syringe format
The new format of Shingrix eliminates the need for making separate vials, streamlining the prevention of shingles (herpes zoster) in adults.
Samsung Bioepis, Harrow partner for ophthalmology biosimilars
Once the commercial licence transfer is completed, Harrow will take full responsibility for the commercialisation of Byooviz and Opuviz in the US.
SandboxAQ, iOncologi collaborate on AI-driven drug discovery
The partnership will focus on developing a high-fidelity mRNA vaccine leveraging SandboxAQ’s AI-driven drug discovery platform and iOncologi’s immunotherapy expertise.
Sanofi gains FDA fast-track status for SAR446597 in geographic atrophy
Sanofi’s SAR446597 is designed to address the underlying pathophysiology of complement-mediated retinal diseases, providing long-term expression of therapeutic proteins.
Acumen, JCR partner to enhance Alzheimer’s therapy delivery
The partnership combines Acumen’s expertise in amyloid beta oligomer-selective antibodies with JCR’s blood-brain barrier-penetrating technology, to improve AD treatment delivery.