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US FDA issues J&J with complete response letter for carisbamate

 
• By Katie McQue

The US FDA has hit Johnson & Johnson with a complete response letter for its anti-epileptic Comfyde (carisbamate). The company has not disclosed the contents, but did say it was evaluating the letter and would "respond to the agency's questions as quickly as possible".

The US FDA has hit Johnson & Johnson with a complete response letter for its anti-epileptic Comfyde (carisbamate). The company has not disclosed the contents, but did say it was evaluating the letter and would "respond to the agency's questions as quickly as possible".

The drug was filed in October as an adjunctive treatment for partial onset seizures in patients aged 16 years and...

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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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China’s Biotechs Were The Small-Cap Rising Stars In H1 2025

 
• By Andrew McConaghie

The list of small-cap companies with the fastest-rising share prices so far this year is dominated by Chinese companies, underscoring their growing contribution to the global biopharma ecosystem.

In Brief: Soleno To Raise $200m To Boost Vykat XR Launch

 
• By Manas Mishra

Soleno Therapeutics will raise about $200m gross proceeds from an offering of 2.35m of its common stock to fund the commercialization of Vykat XR, which became the first drug for Prader-Willi syndrome to gain US approval on March 26.

Glenmark Chief On IGI’s Landmark Trispecific Deal: Strong Data Excited AbbVie

 
• By Anju Ghangurde

Glenmark’s managing director talks about IGI’s billion dollar-plus deal with AbbVie, ISB-2001’s striking data, the BEAT platform, other "exciting" pipeline assets and the "blood, sweat and tears" to get to this stage.