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Home » Authors » Tamra Sami

Articles by Tamra Sami

FDA issues complete response letter to Satsuma for migraine NDA over CMC issues

Jan. 18, 2024
By Tamra Sami
The U.S. FDA issued a complete response letter to Shin Nippon Biomedical Laboratories Ltd.’s U.S. subsidiary, Satsuma Pharmaceuticals Inc., for its NDA for dihydroergotamine nasal powder (STS-101) for acute treatment of migraine, with or without aura, in adults. Shin Nippon acquired Satsuma for $220 million in April 2023 and gained rights to STS-101.
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Blue heart and data grid

Windtree out-licenses China rights for heart failure candidate istaroxime to Lee’s Pharma for $138M

Jan. 18, 2024
By Tamra Sami
Windtree Therapeutics Inc. is out-licensing China rights for phase III-ready heart failure candidate istaroxime to Lee’s Pharmaceutical Ltd. for $138 million, plus royalties. Lee’s, of Hong Kong, plans to begin a phase III study for istaroxime in acute heart failure in greater China, while Windtree, of Warrington, Pa., will conduct a global trial in cardiogenic shock, a form of sudden heart failure. Windtree reported positive phase II data in April 2022 that tested istaroxime in cardiogenic shock, which happens when the heart cannot pump enough blood and oxygen to vital organs.
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Taiwan’s Bora Pharma to acquire Upsher-Smith for $210M

Jan. 17, 2024
By Tamra Sami
Taiwan’s Bora Pharmaceuticals Co. Ltd. is acquiring Upsher-Smith Laboratories Inc. from Sawai Group Holdings Co. Ltd. and Sumitomo Corp. of Americas for $210 million to boost its commercial presence in the U.S.
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Toll like receptor in cell membrane illustration
Newco news

Axelia Oncology takes its TLR2/6 agonist into the clinic to harness the innate immune system

Jan. 16, 2024
By Tamra Sami
Axelia Oncology Pty Ltd. was spun out of Ena Respiratory Pty. Ltd., which developed a series of synthetic Toll-like receptor (TLR) 2/6 agonists for nasal delivery to treat respiratory infections, including influenza and SARS-CoV-2. Although the pegylated TLR 2/6 agonist, INNA-051, was initially focused on antiviral activity, the company discovered that it also worked in oncology models, and Axelia was spun out to focus on oncology, CEO Phil Kearney told BioWorld.
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China’s NMPA accepts Hutchmed’s sovleplenib NDA for primary immune thrombocytopenia

Jan. 16, 2024
By Tamra Sami
China’s National Medical Products Administration (NMPA) has accepted for review Hutchmed’s NDA for sovleplenib (HMPL-523) for treatment of primary immune thrombocytopenia.
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China’s Ji Xing signs flurry of Asian deals to advance cardiovascular pipeline and global ambitions

Jan. 16, 2024
By Tamra Sami
Shanghai-based Ji Xing Pharmaceuticals has signed a number of licensing deals over the last week for China rights to cardiovascular drugs to advance its pipeline and its global ambitions, partnering most recently with Tokyo-based TMS Co. Ltd. after the Chinese company acquired global rights for TMS-007 (also known as BIIB-131) from Biogen Inc.
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China’s Ji Xing signs flurry of Asian deals to advance cardiovascular pipeline and global ambitions

Jan. 12, 2024
By Tamra Sami
Shanghai-based Ji Xing Pharmaceuticals has signed a number of licensing deals over the last week for China rights to cardiovascular drugs to advance its pipeline and its global ambitions, partnering most recently with Tokyo-based TMS Co. Ltd. after the Chinese company acquired global rights for TMS-007 (also known as BIIB-131) from Biogen Inc.
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China’s NMPA accepts Hutchmed’s sovleplenib NDA for primary immune thrombocytopenia

Jan. 11, 2024
By Tamra Sami
China’s National Medical Products Administration (NMPA) has accepted for review Hutchmed’s NDA for sovleplenib (HMPL-523) for treatment of primary immune thrombocytopenia.
Read More
Mindear app

Mindear app reduces tinnitus impact in 64% of users

Jan. 10, 2024
By Tamra Sami
Researchers from the University of Auckland have developed a smartphone app called Mindear that reduced the impact of tinnitus in two-thirds of users over eight weeks.Tinnitus, often referred to as ringing in the ears, is the perception of sound without an external source and affects 10% to 15% of the global adult population. Previous studies to treat tinnitus have focused on neuromodulation devices, but a smartphone app could make treatment more accessible to a wider population.
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US FDA issues complete response for Astellas’ zolbetuximab BLA

Jan. 9, 2024
By Tamra Sami
The U.S. FDA issued Astellas Pharma Inc. a complete response letter for its BLA for zolbetuximab, citing unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for claudin 18.2-targeting drug, which was recently listed in the 2024 edition of Clarivate’s Drugs to Watch.
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