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Regeneron’s COVID-19 Antibody Cocktail Shows Early Promise, But Does It Merit An EUA?

Could Help Patients Who Lack Own Antibody Response

 
• By Andrew McConaghie

Data from the first 275 patients in the trial are promising, but outside experts say they are wary of another hasty Emergency Use Authorization. 

Covid test
Serology tests found around 40% of trial patients had generated no antibodies against the disease - making them higher risk, and more likely to benefit from REGN-COV2.

Early data from Regeneron Pharmaceuticals, Inc.’s REGN-COV2 shows the antibody cocktail has promise in treating non-hospitalized COVID-19 patients, with the most significant results in individuals who have not mounted an antibody response against the infection.

The first data from a descriptive analysis of the first 275 patients treated in a seamless Phase I/II/III trial showed the targeted antibody therapy reduced viral load and the time to alleviation of symptoms in non-hospitalized patients – but only showed clear benefits in ‘seronegative’

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

 
• 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

 
• 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

 
• 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

 
• 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

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Takeda Plans US Investment But Sees Little Impact From Tariffs

 
• By Alaric DeArment

The Japanese drug maker is on track for three pivotal Phase III readouts and two regulatory submissions in 2025.

Q1 S&E In Brief: Tracking New Launches And Catalysts In Biopharma

 
• By Jessica Merrill and Joseph Haas

Neurocrine, Madrigal and Vanda updated investors on new drug launches, while Cytokinetics talked to investors about an FDA extension for aficamten.

Which Firms Are Most Exposed To Prasad’s Possible Accelerated Approvals Clampdown?

 
• By Andrew McConaghie

Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.