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NKGen Biotech Partners with HekaBio to Accelerate Troculeucel Development in Japan

Shots:NKGen Biotech has partnered with HekaBio to accelerate the regulatory, manufacturing & commercial development of troculeucel in JapanAs per the collaboration, HekaBio will lead trials & handle regulatory activities with Japan’s PMDA for pre-market approval of troculeucel in neurodegenerative diseases, incl. Alzheimer’s & Parkinson’s. Also, HekaBio aims for first pts dosing in Japan…
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Keros Therapeutics Reports First Patient Dosing in P-III (RENEW) Trial of Elritercept for Transfusion-Dependent Anemia in Adults with MDS

Shots:Keros has dosed the first pts in P-III (RENEW) trial assessing elritercept vs PBO in adults with transfusion-dependent anemia with very low, low, or intermediate risk myelodysplastic syndromes (MDS)Dosing triggers a $10M milestone under Keros & Takeda’s Jan 2025 deal, in which Takeda gained global rights to develop, manufacture, & commercialize elritercept (excl.…
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Samsung Bioepis Collaborates with Harrow to Commercialize its Ophthalmology Biosimilars in the US

Shots:Samsung Bioepis has entered into a definitive agreement to grant Harrow exclusive commercial rights of its ophthalmology biosimilar portfolio incl. Byooviz, biosimilar to Lucentis (ranibizumab), & Opuviz, biosimilar to Eylea (aflibercept) in the USByooviz has been available in the US through Biogen since its launch in Jun 2022. In Oct 2024, Biogen notified…
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The US FDA Grants Priority Review to Johnson & Johnson’s TAR-200 for BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)

Shots:The US FDA has granted priority review to NDA of TAR-200 for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive HR-NMIBC with CIS &/or papillary tumorsNDA was supported by the P-IIb (SunRISe-1) trial, assessing TAR-200 in pts ineligible or opting out of radical cystectomy that showed an 82.4% CR rate & 52.9% remained cancer-free for at…
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Top 20 Vaccines of 2025
TOP 20

Top 20 Vaccines of 2025 

Shots: Vaccines play a critical role in combating infectious diseases by stimulating antibody production and establishing immune memory. Biopharma companies around the globe continue to drive innovation in vaccine development, targeting both infectious and preventable diseases The global vaccine market was valued at $87.75B in 2024 and is projected to reach $151.96B by 2033, reflecting…
July 17, 20250Comments

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Quince Therapeutics Completes Patient Enrolment in P-III (NEAT) Trial of eDSP for Ataxia-Telangiectasia

Shots:Quince Therapeutics has completed enrolment in its P-III (NEAT) trial to assess eDSP (6 infusions once every 21–30 days) vs PBO in Ataxia-Telangiectasia pts (n=105), incl. 83 pts (6-9yrs.) in primary analysis population & 22 pts aged ≥10yrs.Trial will assess change from baseline to the last efficacy visit using RmICARS as the 1EP; pts…
July 17, 20250Comments

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The US FDA Approves GSK’s Shingrix Prefilled Syringe Presentation to Protect Individuals Against Shingles

Shots:The US FDA has approved prefilled syringe formulation of Shingrix (Recombinant Zoster Vaccine) for the prevention of shingles (herpes zoster)Approval was supported by data demonstrating its technical comparability to the existing format, which incl. 2 separate vials, a lyophilised antigen & a liquid adjuvant, combined by healthcare professionals before useAdditionally, Shingrix prefilled…
July 17, 20250Comments

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