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US FDA Accepts Roche's Lunsumio-Polivy Filing for Relapsed Large B-Cell Lymphoma
The US Food and Drug Administration (FDA) has accepted Roche’s supplemental Biologics License Application for the Lunsumio and Polivy combination in relapsed or refractory large B-cell lymphoma. The filing is supported by Phase 3 SUNMO study data showing a 59 percent reduction in the risk of disease progression or death.
TGA Issues New Guidance on Prescription Medicine Advertising Rules
Australia’s Therapeutic Goods Administration (TGA) has released updated guidance on prescription medicine advertising restrictions, providing practical examples to help businesses and individuals understand compliance requirements and meet their regulatory obligations.
Assertio Announces Completion of Merger with Zydus Lifesciences
Assertio has completed its merger with Zydus Lifesciences, becoming a wholly owned subsidiary of the company. Following the acquisition, Assertio shares have been delisted from Nasdaq, with shareholders receiving USD 23.50 per share in cash.
Bayer Completes Acquisition of Perfuse Therapeutics
Bayer has completed the acquisition of Perfuse Therapeutics, strengthening its ophthalmology pipeline and expanding its portfolio of innovative eye disease treatments.
IPC Represents India at the 16th International Meeting of World Pharmacopoeias in Brazil
The Indian Pharmacopoeia Commission (IPC) represented India at the 16th International Meeting of World Pharmacopoeias in Brazil, highlighting advances in pharmacopoeial standards and global harmonisation. India’s leadership in setting quality standards for complex medicines and strengthening international regulatory collaboration was widely recognised.
Marengo Asia Hospitals, Gurugram, showcased its 1,400 bone marrow transplants while highlighting emerging therapies such as gene editing and cellular treatments that are reshaping the future of blood disease care.
Allergan Aesthetics Secures FDA Approval for Skinvive by Juvederm to Treat Neck Wrinkles
Allergan Aesthetics, an AbbVie company, has received US FDA approval for Skinvive by Juvéderm to reduce neck wrinkles and improve overall neck appearance.
WuXi Biologics Secures 4th EMA GMP Certification for Suzhou Facility
WuXi Biologics’ Suzhou Biosafety Testing Center has received its 4th EMA GMP certification, supporting European Union (EU) Marketing Authorisation (MA) applications for 19 biologics from 13 stakeholders.
Allergan Aesthetics Secures US FDA Approval for Skinvive to Treat Neck Wrinkles
Allergan Aesthetics has received the US Food and Drug Administration (FDA) approval for Skinvive by Juvéderm to reduce neck wrinkles and improve overall neck appearance. The injectable treatment helps the skin retain moisture, softness and smoothness, providing a first-of-its-kind option for addressing age-related and ‘tech-neck’ lines.
Insilico Begins Phase 1 Trial of AI-Designed NLRP3 Inhibitor ISM8969
Insilico Medicine has completed first-in-human dosing of its AI-designed NLRP3 inhibitor ISM8969 in a phase 1 clinical trial. The oral, brain-penetrant therapy is being developed with Hygtia Therapeutics for chronic neuroinflammation and CNS disorders, including Parkinson’s disease, marking a key milestone in AI-driven drug development.
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