All articles by Pradeep Bairaboina
Pradeep Bairaboina
US FDA approves Incyte’s Zynyz for advanced anal canal cancer treatment
The approval of Zynyz as a monotherapy was based on the POD1UM-202 study, which reported an objective response rate of 14% and a disease control rate of 49%
Sarepta’s Elevidys receives conditional approval in Japan for DMD
The approval is based on the efficacy and safety data from clinical studies, including long-term functional results from the global Phase 3 EMBARK study
US FDA accepts Regenxbio’s application for MPS II gene therapy
The application seeks accelerated approval for treating Mucopolysaccharidosis II (MPS II), commonly referred to as Hunter syndrome
Recipharm and PLG announce strategic partnership to accelerate development projects
The two companies will ensure customers receive comprehensive support from early-stage development to approval and market access
Daiichi Sankyo seeks approval for Enhertu in Japan for HER2 positive tumours
The New Drug Application focuses on treating adult patients with HER2 positive advanced or recurrent solid tumours that do not respond to or cannot tolerate existing standard treatments
Thermo Fisher to invest $2bn to strengthen US healthcare supply chain
The investment plan includes $1.5bn for expanding and upgrading US manufacturing facilities, along with $500m directed towards R&D focused on high-impact innovations
Granite Bio secures $100m funding to advance autoimmune disease treatments
The financing includes a $30m Series A round, led by founding investors Versant Ventures and Novartis Venture Fund, and a $70m Series B round, led by Forbion and Sanofi Ventures
Guardant Health announces strategic collaboration with Pfizer
Multi-year global collaboration will utilize Guardant liquid biopsy portfolio in research and clinical applications and evaluate utility of ctDNA for monitoring therapy response
US FDA approves argenx’s prefilled syringe for neurological conditions
The prefilled syringe includes efgartigimod alfa and hyaluronidase-qvfc and can be administered subcutaneously in 20 to 30 seconds by patients, caregivers, or healthcare providers
Trump administration’s FDA cuts may delay new medicine reviews
The move, which is part of a broader initiative by President Donald Trump to reduce the federal workforce, could potentially hinder efforts to expedite the availability of promising treatments