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Tropical Disease Development Partnerships Want More Help From U.S. FDA

 
• By Derrick Gingery

The agency’s infrastructure is not attracting many of the Product Development Partnership sponsors, Aeras official says, but new draft guidance could help.

Product development partnerships want more information from U.S. FDA about how the agency will use the flexibility outlined in a draft guidance to consider new drugs for neglected tropical diseases.

FDA said in the draft guidance that it could consider INDs based solely on ex-U.S. trials and use...

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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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New Regenxbio DMD Data Support Gene Therapy Accelerated Approval

 
• By Joseph Haas

Regenxbio reported functional and biomarker data from an ongoing study of RGX-202, which it hopes to file for approval in Duchenne muscular dystrophy in 2026.

ASCO: Kite’s Dual-Targeting CAR-Ts Could Mitigate Toxicity, Resistance

 
• By Alaric DeArment

Gilead’s Kite division presented Phase I data for its next-generation CAR-T therapy KITE-363 in patients with B-cell lymphomas.

A MoonLake Buyout Would Boost Merck & Co’s Immunology Ambitions

 
• By Andrew McConaghie

As the patent protection clock ticks down on Merck’s flagship blockbuster Keytruda, the company is reported to be pursuing the inflammation and immunology biotech. Such a move would bulk up its sparse I&I pipeline.