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Start-Ups in Obesity

 
• By Melanie Senior

The unanimous rejection of Sanofi-Aventis' obesity drug rimonabant by an FDA Advisory Committee in June hasn't put off the host of firms, large and small, seeking an answer to the obesity epidemic. Despite the many drug casualties in this area, still, it seems, no approach is ruled out.

Last month, an FDA advisory committee unanimously rejected Sanofi-Aventis’ high-profile obesity drug rimonabant (Acomplia/Zimulti) due to concerns over depression side effects, even though the drug is approved and widely available (if not reimbursed) in Europe. The rejection was a huge blow to Sanofi, which was expecting billion dollar sales potential, and to many patients hoping for a more effective treatment. It also symbolized—and raised concerns over—rising safety thresholds at an FDA under increasing political pressure.

But none of this is putting off the host of pharmaceutical and biotech firms seeking the answer to the obesity...

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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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Dr Reddy’s On Semaglutide Prospects, Capacity And There’s An IP Hearing To Watch

 
• By Anju Ghangurde

Dr Reddy’s CEO discusses the growth opportunity for semaglutide, including production capacity and ‘crazy’ demand indications, and a potential 20-plus product GLP-1 portfolio. All eyes are also on an upcoming hearing in India pertaining to Novo Nordisk’s semaglutide patent in the country.

GSK Gains Hengrui’s PDE3/4 Inhibitor, Options For 11 Early Assets In Potential $12bn Deal

 
• By Dexter Jie Yan

Deal Snapshot: The addition of Hengrui's HRS-9821, a China-originated fast-follower of Verona’s Ohtuvayre in chronic obstructive pulmonary disease, should enable GSK’s COPD therapy portfolio to stack up well against increasing competitors in the indication, including biologics and small molecules.

Quick Listen: Scrip’s Five Must-Know Things

 
• By Ian Haydock

In this week's episode: Sanofi’s Vicebio buy; Sarepta halts US Elevidys shipments; Novartis warning over Europe; US CRL for Genentech’s Columvi; and an interview with Novavax.