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

Lessons Learnt From Aduhelm, Eisai Is Preaching Patience On Alzheimer’s Drug Leqembi

Eisai has spent 25 years looking for a breakthrough in Alzheimer’s and warns that healthcare systems need to undergo a major shift to accommodate its breakthrough drug.

Commercial Companies

10 Clinical Trials To Watch Out For In 2023

Scrip surveys the Phase III clinical trial readout landscape and picks 10 of the more interesting studies set to report in 2023, with a few added extras. AstraZeneca, Novo Nordisk, Novartis and Roche feature heavily.

Scrip Perspectives Clinical Trials

Cassava’s Simufilam Continues To Alienate Investors Despite Some Phase II Alzheimer’s Promise

The US firm is touting top-line data from an open-label Alzheimer’s disease trial as a net positive, but the lack of p-values and a declining trend in efficacy left some investors and analysts lukewarm.

Neurology Companies

US FDA Rejects Lilly’s Bid For Donanemab Accelerated Approval In Early Alzheimer’s

Lilly plans to seek traditional approval for its amyloid-clearing antibody after the Phase III TRAILBLAZER-ALZ 2 trial reads out in Q2, but it loses important ground in reimbursement negotiations.

Complete Response Letters Neurology

No Fast Track For Lecanemab In EU Disappoints Eisai

Despite being hailed as a potential breakthrough for Alzheimer’s, the EMA will not fast-track lecanemab, underscoring differences with the FDA’s frequent use of accelerated pathways.

Commercial Companies

Irlab Parkinson's Pact With Ipsen Up In The Air

The Swedish firm’s Parkinson's disease drug has failed to hit its primary endpoint in a Phase IIb study but Irlab believes that positive results on secondary goals merit further development of mesdopetam.

Neurology Clinical Trials

Karuna Gears Up To File KarXT, A Schizophrenia ‘Gamechanger’

New CEO Bill Meury said Karuna had plenty of time, money and physician enthusiasm to ensure a US launch in 2024 would be a success.

Commercial Companies

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast version of Five Must-Know Things: major trends and deals from the recent J.P. Morgan meeting, the impact of the US Inflation Reduction Act, the pricing of Alzheimer’s drug Leqembi and five blockbusters set to lose exclusivity this year.

Commercial Business Strategies

Alto De-Risks Precision Approach To Psychiatry With Phase IIa Depression Success

The US biotech’s candidate, ALTO-100, has hit the mark in a Phase IIa depression trial, de-risking the firm’s novel precision approach to psychiatry R&D and triggering the start of a Phase IIb study.

Clinical Trials Neurology

Eisai Files Alzheimer’s Drug Lecanemab In Europe But Will EMA Grant Fast Track?

Eisai and Biogen’s aducanumab was never approved in the European Union and while lecanemab is generating more confidence, a fast track review has not yet been confirmed.

Approvals Companies

Cimzia Keeps Raking In The Cash As UCB Waits For New Products Impact

The Belgian group’s older products helped push 2022 revenues to the top of their guidance range as the peak sales forecast for the new epilepsy drug Fintepla is set at €800m.

Sales & Earnings Business Strategies

NeuroDerm Parkinson’s Drug Inches Closer To Market With Phase III Win

Mitsubishi Tanabe Pharma paid $1.1bn to acquire the Israeli biotech in 2017 for a drug that analysts forecast to represent a market opportunity worth up to $1.7bn in peak sales.

Clinical Trials Business Strategies
See All
UsernamePublicRestriction

Register