As expected, the U.S. FDA gave its go-ahead to lecanemab, an amyloid-beta binder for mild cognitive impairment caused by Alzheimer’s disease (AD) and mild AD from Biogen Inc. and Eisai Co. Ltd, which have assigned to the compound the brand name Leqembi.
Once a rarity, billion-dollar deals are now coming fast and furious. Now three have appeared in only a few days. Gene therapy developer Voyager Therapeutics Inc. and Neurocrine Biosciences Inc. continued a longstanding partnership by agreeing to develop treatments for neurological diseases and for three new programs with rare CNS targets. Cytomx Therapeutics Inc. and Moderna Inc. entered a deal worth a potential $1.24 billion to Cytomx for generating and developing treatments in oncology and non-oncology. In the third deal, Royalty Pharma plc acquired an interest in Ionis Pharmaceuticals Inc.'s royalty in Biogen Inc.'s Spinraza (nusinersen) and Novartis AG's pelacarsen for up to $1.125 billion.
In the wake of ongoing criticism over the U.S. FDA’s 2021 accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, the percentage of novel drugs receiving accelerated approval last year was the lowest it’s been since 2018.
As expected, the U.S. FDA gave its go-ahead to lecanemab, an amyloid-beta binder for mild cognitive impairment caused by Alzheimer’s disease (AD) and mild AD – together known as early AD – from Biogen Inc. and Eisai Co. Ltd, which have assigned to the compound the brand name Leqembi.
Citing an "atypical FDA review process and corporate greed" ahead of the controversial approval of Biogen Inc.'s Aduhelm (aducanumab), Energy and Commerce Committee Chairman Frank Pallone (D-N.J.) called for "corrective actions" at the agency to "re-earn the trust of the American people." Pallone's comments prefaced a report drawn from 18 months of investigation around the regulatory review and approval process for the Alzheimer's disease drug, as well as Biogen’s pricing strategy.
Eisai Co. Ltd. and Biogen Inc. presented the full data set for the Clarity Alzheimer’s disease trial of lecanemab at the 2022 Clinical Trials on Alzheimer’s Disease, which was simultaneously published in the New England Journal of Medicine. The data supported the top-line results released in September 2022.
Biogen Inc. and C4 Therapeutics Inc. have disclosed proteolysis targeting chimera (PROTAC) compounds comprising a degradation signaling moiety such as E3 ubiquitin ligase-binding moiety covalently linked to a Bruton tyrosine kinase (BTK)-targeting moiety through a linker reported to be useful for the treatment of leukemia and lymphoma, multiple sclerosis, atopic dermatitis, rheumatoid arthritis and systemic lupus erythematosus.
Eisai Co. Ltd. and Biogen Inc. presented the full data set for the Clarity Alzheimer’s disease trial of lecanemab at the 2022 Clinical Trials on Alzheimer’s Disease, which was simultaneously published in the New England Journal of Medicine. The data supported the top-line results released in September 2022.
The shadow of two reported patients’ deaths hovers over Eisai Co Ltd. and Biogen Inc.’s Alzheimer’s disease treatment, lecanemab, as the companies prepare to present phase III study data on the drug later today at the 15th Clinical Trials on Alzheimer's Disease conference.
An uptick in positive clinical data reported in recent months has helped nudge the BioWorld Biopharmaceutical Index (BBI) to its highest point this year. BBI is up by 15.58%, significantly higher than the 1.36% increase recorded at the end of August, just as statistically significant clinical results began to roll in from a number of biopharma companies.
