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

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: landmark results for lecanemab in Alzheimer’s; other Alzheimer’s players rise after the lecanemab results; Leqvio’s importance to Novartis; Pfizer’s secret sauce for digitalization; and Amgen’s clinical trial diversity efforts.

Clinical Trials Neurology

Amylyx’s Relyvrio Could See Fast Sales Growth, But Also Spark Pricing Debate

The FDA gave full approval based on a Phase II study, without the need for Phase III confirmatory data, for Amylyx’s ALS drug Relyvrio but the $158,000 WAC could spark a debate over pricing.

Approvals Market Access

Biohaven’s Non-Migraine Portfolio Takes Another Hit As Verdiperstat Fails In ALS

Pfizer is buying Biohaven's migraine portfolio, but the rest of the pipeline is poised to be spun out and there have been two development setbacks. Despite verdiperstat's failure in ALS, the field had a same-day win with Amylyx's Relyvrio approval. 

Neurology Clinical Trials

Rising Tide Lifts Many Ships In Wake Of Eisai/Biogen’s Lecanemab Readout

Eisai and Biogen had double-digit stock price gains based on the positive Phase III readout for lecanemab. The good news also lifted competitors Lilly and Roche as well as earlier-stage Alzheimer’s drug developers.

Clinical Trials Neurology

A Banner Moment For Alzheimer's Positions Eisai/Biogen At The Head Of The Pack

Eisai and Biogen, who have an accelerated approval decision pending in the US, said they will seek traditional approvals for lecanemab by Q1 2023 based on positive results from the Phase III Clarity AD trial.

Clinical Trials Strategy

Biogen Prepares More Doubtful Phase III Results For FDA Scrutiny, This Time In ALS

After the Aduhelm controversy, Biogen has another neurodegenerative disease drug which so far can only show efficacy against surrogate biomarkers – will the FDA be swayed again this time?

Clinical Trials Commercial

Bluebird Confident In Financial Runway For Skysona Launch

The $3m gene therapy for the rare disease cerebral adrenoleukodystrophy marks bluebird’s second approval in just under a month.

Approvals Gene Therapy

The Moment Of Truth For Three Alzheimer’s Drugs Beckons: What To Expect

After the Aduhelm controversy, Eisai/Biogen, Roche and Lilly are lining up Phase III results for their candidates which, against the odds, they hope could finally represent real progress in Alzheimer’s treatment. Scrip takes a look at the key questions surrounding the field as the drugs await their fate.

Neurology Companies

ICER Pushes ALS Drug Makers To Moderate Launch Price While Awaiting Confirmatory Data

The US drug pricing watch dog issued a final assessment on Amylyx's AMX0035 and Mitsubishi Tanabe's Radicava for ALS.

Pricing Debate Neurology

Roche Plays Down Reliance On TIGIT And Alzheimer’s Drugs For Growth

Pharma chief Bill Anderson was optimistic about growth prospects, and downplayed Roche’s reliance on two near-term readouts at an investor day in London.

Companies Research & Development

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: Axsome gets broad label for new depression drug; Argenx CEO on Vyvgart’s success; Chinese firms delist from US; solid results for Novo Nordisk’s new diabetes combo; and women leaders herald change at foreign firms in India.

Commercial Companies

Waiting Game For Minerva After Roluperidone US Filing

The firm’s potential new therapy for the negative symptoms of schizophrenia is now in the hands of the US Food and Drug Administration – some have concerns over whether the supporting data will be enough.

Companies Approvals
See All
UsernamePublicRestriction

Register