Managing Editor, US Commercial News
Mandy reports on daily biopharma developments, writes feature stories and produces Scrip's Finance Watch column. She covers finance, start-ups, dealmaking, clinical trial results, quarterly earnings reports, commercial competition and corporate strategy.
Mandy regularly interviews everyone from big pharma CEOs to biotech start-up founders, enhancing her expertise on industry trends and market dynamics. She also is interested in drug pricing and novel reimbursement strategies, new treatments in areas of true unmet need, diversity in the biopharma industry and novel approaches to drug development. She has been a business reporter since 2000, covering biopharma, biotech law and commercial real estate.
Latest From Mandy Jackson
The company believes the Phase III Clarity AD results offer a high level of evidence that may convince the Centers for Medicare and Medicaid Services to change its stance on anti-amyloid antibodies for lecanemab.
Ivan Cheung, Eisai’s US CEO, explains the ‘question-by-question’ the company is taking to convince the Centers for Medicare and Medicaid Services that its Phase III Clarity AD results in Alzheimer’s offer the ‘high level of evidence’ needed for smooth reimbursement of lecanemab.
While Phase III results for Eisai and Biogen’s lecanemab show amyloid clearance provides benefit and Roche’s Phase III gantenerumab data are supportive, more data and certainty of access to treatment are needed.
Lilly’s donanemab showed faster, deeper amyloid clearance versus Biogen/Eisai’s Aduhelm and Roche’s failed Phase III gantenerumab studies showed the importance of deep, rapid removal.
Alzheimer’s patients treated with the amyloid protofibril-clearing antibody had slower disease progression compared to placebo, with differences increasing over time. Safety concerns, however, are growing.
Phase III results for Eisai/Biogen’s lecanemab are the main event at the Clinical Trials on Alzheimer’s Disease meeting, but other data – even Roche’s failed Phase III gantenerumab studies – also may have implications for the amyloid-clearing antibody.