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Rondo Therapeutics Begins First-in-Human Trial of Novel CD28 - Nectin-4 Bispecific for Solid Tumours
Rondo Therapeutics, a clinical-stage biopharmaceutical company developing next-generation T-cell engaging bispecific antibodies for solid tumours, has begun dosing patients in its phase 1/1b clinical trial of RNDO-564.
India Broadens Vaccine Partnership as BIRAC - CEPI Deal Extended to mAb Research
The Union Cabinet has approved the renewal and expansion of the strategic partnership between the Biotechnology Industry Research Assistance Council (BIRAC) and the Coalition for Epidemic Preparedness Innovations (CEPI).
J&J Reports 74% One-Year Disease-Free Survival with INLEXZO in High-Risk NMIBC
Johnson & Johnson reported strong new data from Cohort 4 of the SunRISe-1 study, showing that INLEXZO (gemcitabine intravesical system) achieved a 74 percent one-year disease-free survival rate in patients with BCG-unresponsive, high-risk papillary-only NMIBC, with over 95 percent progression-free and more than 92 percent avoiding bladder removal.
Mark Cuban Urges Trump to Remove FDA Fees to Boost USA Generics Manufacturing
Billionaire entrepreneur Mark Cuban has urged Donald Trump’s administration to scrap the high regulatory fees charged by the USA Food and Drug Administration (FDA) for generic drug approvals.
ALS Association Announces USD 2M Support for Emerging ALS Treatments
The ALS Association has awarded $2 million through its Hoffman ALS Clinical Trial Awards Program to advance two early-stage therapeutic candidates, supporting efforts to accelerate the development of new treatments for the disease.
Virax Biolabs Closes USD 5 Million Private Placement
Virax Biolabs has closed a USD 5 million private placement, extending its cash runway into the first half of 2028 and supporting ongoing regulatory studies for its ViraxImmune platform, including long COVID and post-acute infection syndrome programmes, alongside planned FDA and MHRA submissions and platform expansion initiatives.
AlidaBio Launches EpiPlex Duo-Mod for Dual m6A-Inosine Mapping with RNA Expression Profiling
AlidaBio has launched the EpiPlex Duo-Mod Service, offering simultaneous m6A and inosine mapping with integrated gene expression profiling, enabling researchers to compare modification patterns and transcriptional changes from a single RNA input.
Ipca Labs Receives US FDA Form 483 with Three Observations after Tarapur Facility Inspection
The US Food and Drug Administration (US FDA) has completed an inspection of Ipca Laboratories' Active Pharmaceutical Ingredients (APIs) manufacturing plant in Tarapur, Palghar (Maharashtra).
Immorta Bio Reports Tumour Reduction Across Multiple Cancer Models with SenoVax
Immorta Bio has reported promising pre-clinical results showing that its anti-aging vaccine, SenoVax, reduced tumours across multiple validated cancer models. Developed in collaboration with academic institutions, the platform aims to dismantle tumour defense mechanisms and offer a non-toxic, longevity-driven approach to cancer treatment.
Lupin Receives Tentative US FDA Nod for Siponimod Tablets, Generic to Novartis' Mayzent
Lupin has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Siponimod Tablets in strengths of 0.25 mg, 1 mg and 2 mg.
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