Following a data-cleaning delay and mixed results in Alzheimer’s disease, Annovis Bio Inc. reported phase III Parkinson’s disease data showing treatment with buntanetap stops cognitive decline and improves motor and other functions, including postural instability and gait difficulty, meeting all primary and secondary endpoints.
China’s National Medical Products Administration authorized the country’s first cetuximab biosimilar with the approval of Simcere Zaiming’s Enlituo (CMAB-009, cetuximab beta injection) in combination with chemotherapy as first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer. The biosimilar references originator drug Erbitux (cetuximab, Eli Lilly and Co.).
The U.S. FDA approved three biosimilar products from Samsung Bioepis Co. Ltd., Tanvex Biopharma Inc. and Formycon AG as follow-on biologics to Stelara (ustekinumab), Neupogen (filgrastim) and Eylea (aflibercept), respectively, on June 28.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Formycon, Humacyte, Idorsia, Longboard, Mesoblast, Sandoz, Springworks, Syncromune, Taurx, Valneva.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alvotech, Ardelyx, Cassava, Dormer, Kashiv, Verrica.
In the first five months of 2024, the BioWorld Neurological Diseases Index (BNDI) saw a 10.35% decline, underperforming both the Nasdaq Biotechnology Index (NBI), which rose by 0.7%, and the Dow Jones Industrial Average (DJIA), which increased by 2.64%. This represents an additional drop for BNDI, which closed February with a 4.1% decline. In contrast, in 2023, the BNDI closed with a 4.36% increase, outperforming the NBI, which rose by 3.74%, but not matching the 13.7% rise seen in the DJIA.
At a time when much of the biopharma space can’t seem to get enough of antibody-drug conjugates (ADC), Bristol Myers Squibb Co. is backing away from a potential $3 billion-plus collaboration with Eisai Co. Ltd., handing back full rights to the latter’s folate receptor alpha-targeting ADC, farletuzumab ecteribulin (FZEC), citing a portfolio reprioritization. Global rights to FZEC now reside with Tokyo-based Eisai, which said it intends to accelerate work on the candidate, which is in three clinical studies, including two phase II trials in gynecological cancers and non-small-cell lung cancer.
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