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Suicide Warnings For Valeant’s Siliq Could Hinder Access To Psoriasis Treatment

 
• By Michael Cipriano

While an FDA advisory committee unanimously supported approval of the plaque psoriasis drug brodalumab, several recommended a black box warning on suicide risk that could limit sales of the drug.

Valeant Headquarters

The variety of strict safety recommendations from the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee could have the unintended consequence of limiting access to Valeant Pharmaceuticals International Inc.’s plaque psoriasis candidate Siliq (brodalumab), should it reach the market.

Although all 18 panelists recommended the treatment for approval, several said they would only support the FDA’s backing if the labeling for the drug includes a black box warning for the

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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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Finance Watch: Deerfield Closes $600m-Plus VC Fund; Gates Speeds Up Health Investments

 
• By Mandy Jackson

Private Company Edition: Deerfield’s third innovations fund will back therapeutics and other opportunities, the Gates Foundation – a sometimes funder of biotech firms – will spend $200bn over the next 20 years, and NewLimit raised a $130m series B round, among other financings.

Pipeline Watch: Six Approvals And Thirteen 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.

Pharma Left Hanging After US/UK Trade Pact

 
• By Kevin Grogan

An ‘historic economic prosperity deal’ does not include the sector.