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OSE Immunotherapeutics gets new US patent for Tedopi in cancer patients
The patent is said to validate the unique combination of multiepitope that is given to patients with HLA-A2 positive non-small cell lung cancer when PD-1/PD-L1 immune checkpoint inhibitor therapy has failed
Samsung Biologics signs two production deals worth $897m with Pfizer
Under the agreements, Samsung Biologics will manufacture biosimilar products ranging from oncology and inflammation to immunotherapy in the period to 2029 at its new plant in South Korea
Janssen’s JNJ-2113 meets primary, secondary endpoints in Phase 2b FRONTIER 1 trial
In the trial, most patients who received JNJ-2113 achieved the primary endpoint of Psoriasis Area and Severity Index (PASI) 75 along with PASI 90 and PASI 100 compared to the placebo at week 16
Jacobio Receives CDE Approval for Glecirasib’s Pancreatic Cancer Pivotal Study in China
The pivotal clinical trial approved in China will evaluate the efficacy and safety of Glecirasib as a single agent for the second line treatment or above of Pancreatic Cancer patients with a KRAS G12C mutation
China NMPA approves RareStone’s pitolisant (Wakix) for the treatment of narcolepsy
pitolisant is the first and only treatment drug approved in mainland China for narcolepsy
Biocon Biologics launches Humira’s biosimilar Hulio in US
The list price for HULIO is 5% less than the current list price of the rheumatoid arthritis drug and the HULIO is offered at a list price that is almost 85% less than the existing Humira list price
Amneal Launches Authorized Generic for Xyrem (sodium oxybate) and Receives FDA Approval for Five Complex Generics in the Second Quarter
Launches authorized generic for Xyrem (sodium oxybate) in the US, representing another new complex generic product launch
Bausch + Lomb to buy certain ophthalmology assets of Novartis for up to $2.5bn
The consideration includes $1.75bn in upfront cash and up to $750m in the form of potential milestone payments contingent on future sales of Xiidra, SAF312, and OJL332
Zai Lab and argenx get China’s NMPA approval for VYVGART for GMG
The approval in China was based on the results from the global Phase 3 ADAPT trial in which VYVGART met its primary endpoint with a positive response on the MG-ADL scale
Roche withdraws US indication of Gavreto for RET-mutant medullary thyroid cancer
Both firms decided to voluntarily withdraw the US RET-mutant MTC indication following consultation with the FDA, as the confirmatory late-stage trial could not be activated to fulfil the post-marketing requirement