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TOP STORIES
Eli Lilly’s and Boehringer’s Jardiance met its primary outcome in the Phase III EMPA-KIDNEY study, the largest and broadest SGLT2 inhibitor trial in chronic kidney disease.
Akebia Therapeutics has submitted a Formal Dispute Resolution Request with the FDA regarding the rejection of vadadustat in anemia due to chronic kidney disease.
BioAge Labs, PTC Therapeutics, Biogen and others highlighted novel mechanisms targeting newer pathways in neurodegenerative diseases at the recent Discovery on Target meeting.
In spite of positive Phase IIb results from a thrombosis prevention trial, Ionis is back on the market for a new partner after Bayer returned the rights to the drug to Ionis.
Galapagos’ new “forward faster” strategy will see the departure of the company’s fibrosis and kidney disease programs and 200 staff members.
Sanofi and AstraZeneca won European approval for the first preventative RSV treatment for a broad population of newborns and infants.
Arcus Biosciences and its collaboration partner Gilead Sciences announced during Arcus’ third-quarter report that the company had modified its ARC-10 Phase III trial.
Some executives might book a massage or practice meditation to deal with their stress. Others have a different way to let off steam–spending time with their pets.
The FDA is gearing up for deadlines and PDUFA dates in mid-November with Seagen, Provention, Clarus and Tolmar, and Ligand and Travere.
Apellis is submitting additional 24-month efficacy data to supplement the NDA for its intravitreal candidate pegcetacoplan for GA secondary to AMD.
Working to undo the sins of the past, Colossal Biosciences and the University of Melbourne are attempting to bring back the Tasmanian tiger in a project that could have big implications for human health.
Rubius Therapeutics plans to initiate a large restructuring initiative, which includes laying off 84% of its staff and a possible sale, the company announced Wednesday.
PRESS RELEASES
Expanded sweetener molecule development program aims to broaden access to plant-based sweetening solutions tailored to diverse customer food and beverage categories.
• $5.5 million financing that closed on April 2, 2026 together with $5.7 million in capital raised in Q1-2026, expected to provide Company with cash runway into 2027 • $4.5 million of accrued VAT refunds and R&D refundable tax credits from UK subsidiary begin maturing, including $1.9 million VAT cash refund expected in June 2026 • Successful EMA and Australia TGA (ATGA) meetings aligned around use of existing biomarker and pending release of 3-year overall survival data to support Conditional Marketing Authorisations (CMAs) for OST-HER2 in prevention or delay of recurrence in fully-resected, pulmonary metastatic osteosarcoma (“Metastatic Osteosarcoma”) • 2.5-year overall survival data expected to be released during ASCO 2026 • EMA and ATGA have aligned on key design aspects of confirmatory Phase 3 Metastatic Osteosarcoma protocol required to have commenced prior to grant of CMAs or FDA BLA, including alignment on 3-year overall survival as a primary clinical efficacy endpoint • Upcoming U.S. FDA Type C meeting and U.K. MHRA SAM meeting to align with EMA & ATGA prior to Australia Clinical Trial Notification submission for Phase 3, including alignment on 3-year overall survival as a primary clinical efficacy endpoint. U.S. FDA (“FDA”) Pre-BLA meeting to confirm alignment on surrogate and primary clinical efficacy endpoints with EMA/ATGA, including alignment on 3-year overall survival as a primary clinical efficacy endpoint, and seek decisions on rolling review acceptance and RMAT designation following the EMA and U.K. MHRA granting ATMP designation (EMA/MHRA RMAT equivalent) for OST-HER2 in Metastatic Osteosarcoma • OS Animal Health S-1 filing for proposed ‘Go-Public’ transaction and receipt of SEC comments