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Shire finally files ADHD drug Venvanse in EU

 
• By Francesca Bruce

An EU approval for Shire's attention-deficit hyperactivity disorder (ADHD) drug Venvanse (lisdexamfetamine dimesylate) is edging closer after the UK's medicines regulator, the MHRA agreed to act the reference member state under the decentralised procedure. The drug was first approved in the US back in February 2007 under the name Vyvanse.

An EU approval for Shire's attention-deficit hyperactivity disorder (ADHD) drug Venvanse (lisdexamfetamine dimesylate) is edging closer after the UK's medicines regulator, the MHRA agreed to act the reference member state under the decentralised procedure. The drug was first approved in the US back in February 2007 under the name Vyvanse.

The firm was unavailable to comment on why it had taken so long to seek EU approval. The drug is...

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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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Pipeline Watch: ASCO Dominates Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Quick Listen: Scrip’s Five Must-Know Things

 
• By Ian Haydock

In this week's episode: Sanofi’s Blueprint buy; AstraZeneca’s breast cancer resistance results at ASCO; BMS and BioNTech’s big bispecific deal; Kymera’s Dupixent in a pill; and Degron’s CEO on pipeline and strategy.

Chinese Biotech VC/PE Fundings Rise But Still Modest

 
• By Dexter Jie Yan

LTZ Therapeutics and Beijing Sungen Biomedical are among the Chinese biotechs raising new funding, of around $40m each, based on their clinical assets with novel mechanisms of action. While fundings have risen, they remain moderate however.