Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

CNS

Set Alert for CNS

A Duchenne Breakthrough Awaits In 2023 - But Risks Remain For Sarepta And US FDA

The FDA and Sarepta have had a controversial history with the accelerated approvals of the firm’s earlier drugs for Duchenne muscular dystrophy – but the company’s investigational gene therapy, SRP-9001, now under a priority review, could be a genuine breakthrough.

Approvals Neurology

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: safety debate as more lecanemab data reported; amyloid discussions continue at Alzheimer’s meeting; China COVID unrest affect country’s biotech sector; and Merck’s CMO talks about post-Keytruda plans.

Clinical Trials Business Strategies

Eisai Plots A Meticulous Path To CMS Coverage For Lecanemab

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. 

Neurology Market Access

Lundbeck And Axsome Rival Candidate Data Raise Prospects For First Alzheimer’s Agitation Approvals

The firms unveiled positive Phase III data from their respective assets for treating the agitation seen in Alzheimer’s disease with Lundbeck’s candidate set to become first-to-market for the challenging behavioral symptom.

Clinical Trials Companies

Alzheimer’s Experts: Lecanemab Is A Win, But Also Just The Beginning

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.

Clinical Trials Drug Approval Standards

AC Immune and J&J Advance Tau-Targeting Alzheimer’s Vaccine

AC Immune has seen two big disappointments in its Alzheimer’s pipeline this year, but its partner Johnson & Johnson has put its faith in a novel vaccine-like approach to targeting the disease.

Neurology Commercial

How Much Amyloid Clearance, How Fast Is Needed To Slow Alzheimer’s?

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.

Clinical Trials Neurology

Eisai/Biogen’s Lecanemab Effective Across Endpoints, But Will Safety Limit Use?

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. 

Clinical Trials Drug Safety

Questions About Gantenerumab Failure Remain, But Roche Is Not Yet Finished With Alzheimer’s

Roche’s global head of neurodegeneration, Rachelle Doody, talks to Scrip about the failure of gantenerumab and its next-generation ‘brain shuttle’ technology for Alzheimer’s disease.

Companies Clinical Trials

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: a preview of the CTAD Alzheimer’s meeting; US myeloma drug withdrawal puts pressure on GSK; UniQure/CSL's gene therapy sets new US price record; new leadership at Teva; and Merck’s Frazier cautions against profit maximization.

Business Strategies Commercial

Kyowa Kirin To Offload Selected Mature Portfolio To Grünenthal

The Japanese and German firms agree to establish a joint company to handle 13 mature brands from Kyowa Kirin's portfolio, mainly focused on pain management and including Abstral and PecFent. Grünenthal will own 51% and plans to fully buy out the operation in early 2026.

Commercial Deals

Janssen’s Spravato Beats Antipsychotic In Depression Trial Designed To Increase Uptake

The controversial nasal spray has improved remission rates over an atypical antipsychotic in patients with a challenging form of depression, in Phase III data which could help boost its uninspiring market performance to date.

Clinical Trials Companies
See All
UsernamePublicRestriction

Register