Third patient death potentially linked to lecanemab days before expected FDA decision
A letter published Wednesday in the NEJM links a stroke patient’s death to lecanemab. Eisai investigators respond.
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Entries by BioSpace
Executives reunite at JPM as biotech kicks off 2023
JP Morgan week is shaping up to approximate pre-pandemic attendance levels as executives return to San Francisco after two years of COVID-19-enforced absences.
Market appears to question competitive prospects of Vera’s IgAN therapy
California-based Vera Therapeutics unveiled results Tuesday from the Phase IIb ORIGIN trial showing its immunoglobulin A nephropathy (IgAN) candidate atacicept met the primary endpoint of reduced proteinuria.
BrainStorm preps for Type A NurOwn meeting, shakes up C-suite
BrainStorm Cell Therapeutics concluded 2022 on a cautiously optimistic note as the FDA granted a Type A meeting to discuss the refuse to file letter it served the Israel and New York-based biotech in November for its ALS hopeful, NurOwn. On Wednesday, the company made a series of C-suite moves in what could be a show of confidence in NurOwn’s ability to prevail.
Reanalysis of key trial flags fresh safety concerns for Amgen’s Repatha
A reanalysis of data from the FOURIER trial found a higher risk of cardiovascular death associated with Amgen’s injectable cholesterol therapeutic Repatha (evolocumab), according to a study published last month.
Belharra launches with $130M from Versant, Genentech to advance chemoproteomics platform
Versant Ventures-backed Belharra Therapeutics launched Wednesday with $130 million in total financing to advance its novel chemoproteomics platform.
Chemomab claims mid-stage win in NASH
Topline data from a Phase IIa study showed ChemomAb’s (Chemomab) investigational monoclonal antibody, CM-101, met its primary endpoints of safety and tolerability in nonalcoholic steatohepatitis (NASH), the Israel-based biotech reported Tuesday.
2022’s top 5 FDA drug approvals are major advancements in cancer, cardiovascular disease and rare disorders
As we move into 2023, BioSpace takes a pause to reflect on the year gone by and some of the most remarkable news bits, looking at the top five noteworthy FDA drug and biologic therapy approvals in 2022.
Merck expands ADC footprint with $9.3B Kelun licensing deal
The licensing and collaboration agreement with Chinese company Kelun-Biotech involves the development of seven antibody-drug conjugates candidates against oncology targets.
FDA’s top drug approvals of 2022
The agency’s top five represent an eclectic mix of cancer, cardiovascular and rare disease drugs.
