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Sobi has acquired Arthrosi Therapeutics, adding phase III gout candidate pozdeutinurad (AR882) to its portfolio, with trial results expected in 2026.
US FDA Clears Anuh Pharma Facility with No Form 483 Observations
The Tarapur facility of Anuh Pharma is already an EUGMP/ WHO pre-qualified approved manufacturing facility with nine API’s blocks and two intermediate block with total capacity of 2400 MTPA.
Takeda's Oveporexton NDA Accepted by US FDA with Priority Review for Narcolepsy Type 1
FDA grants Priority Review to Takeda’s investigational orexin receptor agonist oveporexton (TAK-861) for narcolepsy type 1, with a PDUFA decision expected in Q3 this year.
Saudi Nod Positions OneSource for Growth in GLP-1 Therapies
OneSource Specialty Pharma Limited has secured approval from the Saudi Food and Drug Authority (SFDA) for its generic version of Ozempic (semaglutide), enabling the company to begin commercialisation in Saudi Arabia through an exclusive partnership with Hikma Pharmaceuticals.
VectorY Doses First Patient in Phase I/II PIONEER-ALS Trial of TDP-43 Targeting Therapy VTx-002
VectorY initiates clinical evaluation of VTx-002, a first-in-class vectorised antibody therapy targeting TDP-43 pathology in ALS, with first patient dosed at Mass General Brigham.
Chugai Exercises Option for AraLinQ Technology in USD 780 Million ADC Collaboration
Chugai Pharmaceutical Co., Ltd. has exercised its option to license Araris Biotech AG’s proprietary AraLinQ linker-payload platform, deepening an existing research collaboration aimed at developing next-generation antibody-drug conjugates (ADCs).
GSK's RSV Vaccine Arexvy Accepted for Regulatory Review in China for Adults Aged 60 and Above
China’s drug regulator has accepted GSK’s Arexvy for review to prevent RSV-related lower respiratory tract disease in adults 60 and older, with a decision expected in 2027.
FDA Grants Breakthrough Therapy Designation to Sanofi's Wayrilz for Rare Blood Disorder wAIHA
The US FDA has granted breakthrough therapy designation to Wayrilz (rilzabrutinib) for warm autoimmune haemolytic anaemia, while Japan’s health ministry awarded orphan status, accelerating development for the rare disorder.
Lupin Resolves Mirabegron Patent Dispute with Astellas in USD 90 Million Settlement
Lupin Limited has reached a USD 90 million settlement to resolve a patent dispute with Japan-based Astellas Pharma concerning Lupin’s generic version of mirabegron, a treatment for overactive bladder. The agreement concludes ongoing litigation in the United States and provides commercial clarity around Lupin’s continued participation in the market.
Pandorum Technologies Raises USD 18 Million in Series B to Advance Regenerative Therapies
Pandorum Technologies has raised USD 18 million in a Series B funding round to accelerate the clinical development and global market access of its programmable tissue regenerative therapies, with expansion plans spanning the US, Asia and the Middle East.
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