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Intelligent Bio Solutions Forms New Manufacturing Partnership to Boost Global Production and Margins
Intelligent Bio Solutions has entered into a manufacturing partnership with Syrma Johari Medtech to expand its global production capacity, strengthen supply-chain resilience, and support an anticipated improvement of approximately 20 percentage points in gross margin ahead of its planned entry into the US market.
Cogent Biosciences Submits NDA for Bezuclastinib in Non Advanced Systemic Mastocytosis
Cogent Biosciences has submitted a New Drug Application to the US FDA for bezuclastinib in non-advanced systemic mastocytosis, supported by positive results from the SUMMIT pivotal trial and following its Breakthrough Therapy Designation for patients with smouldering systemic mastocytosis and previously treated NonAdvSM.
Silo Pharma Signs LOI with Allucent for Phase I Development of SPC-15
Silo Pharma has executed a Letter of Intent (LoI) with Allucent to support the phase I clinical development of SPC-15, with planned single-ascending dose and multiple-ascending dose studies representing a key clinical milestone for its intranasal treatment targeting PTSD and anxiety disorders.
Johnson & Johnson Acquires Halda Therapeutics to Strengthen Oncology Pipeline with RIPTAC Platform
Johnson & Johnson has completed the acquisition of Halda Therapeutics OpCo, Inc., a clinical-stage biotechnology company developing oral, targeted therapies for solid tumours using its proprietary Regulated Induced Proximity Targeting Chimera (RIPTAC) platform. The transaction was completed for USD 3.05 billion in cash.
Centre Prohibits Manufacturing and Sale of High-Dose Nimesulide Oral Formulations over Safety Risks
The Union Ministry of Health and Family Welfare has banned the manufacture, sale and distribution of all oral formulations of nimesulide containing more than 100 mg in immediate-release dosage form for human use. The order has come into force with immediate effect.
XOMA Royalty and Takeda Amend Mezagitamab Agreement in Royalty Sharing Deal
XOMA Royalty and Takeda have completed a royalty sharing transaction amending their mezagitamab (TAK-079) agreement, with Takeda regaining a majority interest while XOMA Royalty gains milestone and royalty payments linked to nine development-stage assets in Takeda’s externalised portfolio.
Co-Diagnostics Inc, a molecular diagnostics company with a patented platform for developing molecular diagnostic tests, has received an Australian patent grant for its next-generation polymerase chain reaction (PCR) platform, reinforcing its intellectual property base supporting future manufacturing and commercialization.
FDA Accepts for Review INOVIO BLA for INO-3107 in RRP
The US FDA has accepted for review INOVIO’s Biologics Licence Application (BLA) for INO-3107 for the treatment of adults with Recurrent Respiratory Apillomatosis (RRA), assigning a PDUFA action date of 30 October, 2026, and indicating that it does not currently plan to convene an advisory committee meeting for the application.
Vanda Pharma Wins FDA Approval for NEREUS to Prevent Motion Induced Vomiting
Vanda Pharmaceuticals has received FDA approval for NEREUS (tradipitant) to prevent motion-induced vomiting, marking the first new pharmacologic treatment for motion sickness in more than four decades and a significant advance in managing a condition that affects a large segment of the population and impacts military operational readiness.
Evogene Appoints Dr Olga Nissan as VP for Business Development
Evogene has appointed Dr Olga Nissan as Vice President of Business Development, effective 1 January, 2026, bringing to the role a seasoned biotechnology and pharmaceutical leader with extensive experience spanning R&D, clinical development and business operations across pharma, diagnostics and agri-biotechnology sectors.
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