RESCINDED: FDA yanks Amarin ANCHOR SPA; shares tumble

30 Oct 2013

• By Donna Young

Shares of Amarin fell 16% in after-hours trading on 29 October after it revealed the US FDA has rescinded the special protocol assessment (SPA) agreement for the company's placebo-controlled Phase III ANCHOR study of Vascepa (icosapent ethyl) – making it even more unlikely the firm will win an expanded indication for the fish oil pill.

Vascepa, a semisynthetic, 96% ultra-pure ethyl ester of eicosapentaenoic acid, already is approved as an adjunct to diet to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia, or very high TGs (scripintelligence.com,

Final Chance To Have Your Say: Take Scrip's Reader Survey This Week

16 Sep 2024

• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

04 Sep 2024

• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Scrip, or if you love it how it is, now is the time to have your voice heard.

Galapagos Expands Point-Of-Care CAR-T Study To The US

23 Aug 2024

• By Andrew McConaghie

CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.

Analysts Split On Eisai’s Chances Of Changing EU Regulator’s Mind On Leqembi

29 Jul 2024

• By Andrew McConaghie

A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand

Insilico Fast-Tracks First AI-Designed TNIK Inhibitor Into Phase III For IPF

12 May 2025

• By Dexter Jie Yan

InSilico will leapfrog Phase IIb to progress its AI-generated candidate for idiopathic pulmonary fibrosis directly into a Phase III trial in China, as it prepares for an IPO in Hong Kong.