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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 epidemic; indeed, any regulatory roadblock or withdrawal of an 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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Korea Q1 Roundup: Mixed Earnings, Gearing For Possible US Tariffs

 
• By Jung Won Shin

South Korean biopharma companies report a mostly solid first quarter, marked by US growth for original drugs, with several also making preparations for possible US pharma tariffs.

In Brief: Nicox Extends Cash Runway As Kowa Advances NCX 470 In Japan

 
• By Sushmita Panda

Eye drug is already in Phase III trials elsewhere, with results due in Q3. Nicox could earn up to a further €24.5m in milestones and royalties from Kowa alliance.

GSK’s Bet On Spero’s Oral cUTI Antibiotic Poised To Pay Off With New Phase III Data

 
• By Joseph Haas

Spero and partner GSK have Phase III non-inferiority data to support approval of tebipenem as the first oral antibiotic for complicated urinary tract infections.