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Latest From Research & Development

Major Depressive Disorder Patients Emphasize Long-Term Nature Of Disease In Feedback Meeting

Externally hosted patient focused drug development meeting in MDD brings timely messages to US FDA during period of active regulatory review of new applications. Patients stress need for fewer side effects to encourage long-term medication use, and also want fast-acting meds that can “jump start” lifestyle changes. 
Neurology Research & Development

A Call To Action On Antibiotic Development

Recent comments by US FDA’s top infectious disease review manager about the need for new ideas to incentive development of antibiotics should be a call to action for biopharma companies and patient advocates who do not normally consider infectious disease as part of the portfolio.
Research & Development Reimbursement

NASH Drug Development Guidance Encourages Sponsors To Adopt Innovative Trial Designs

Although guidance appears to be free of surprises, US FDA once again made a push for sponsors to adopt seamless trial designs.
Clinical Trials Liver & Hepatic

Global Blood Therapeutics Leaves ASH With Momentum Behind Voxelotor In Sickle Cell Disease

Company revealed that US FDA agreed to accelerated approval pathway for voxelotor in sickle cell disease, with focus on stroke prevention. Updated data from a key trial was also released at ASH.

Clinical Trials Regenerative Medicine

China Gene-Edited Babies' Creator: “I Am Willing To Take Criticism”

In his first public appearance since claiming creation of the world’s first gene-edited babies, Chinese researcher He Jiankui apologized but said he is willing to face criticism for the sake of the families involved.

China Regenerative Medicine

Expanded Access Data Can Support Approval Decisions, US FDA Says

Formal reg not needed, according to agency; officials agree that regulatory flexibility is best way to offer sponsors advice, saying data collected during compassionate use can be helpful in guiding regulatory decisions. 
Clinical Trials Review Pathway
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