CNS

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.

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.

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. 

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.

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.

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?

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

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.

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

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.

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.

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.