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KemPharm: Converting FDA Complete Response Letters Into New Opportunities8/1/2022
KemPharm’s experience in reworking product NDAs following FDA Complete Response Letters has created a unique capability within the company, and helped it move to acquire a potentially valuable asset from distressed biopharma Orphazyme.
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A Network And Pivot Model For Success In Cancer Drug Development7/1/2022
When CEO Avanish Vellanki founded and incorporated Rain Therapeutics on his living room couch in the spring of 2017, there was no drug in development, no money, and a team of only four people.
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Transitioning To Orphan Drug Commercialization: A Q&A With Albireo Pharma's CEO Ron Cooper7/1/2022
Albireo Pharma CEO Ron Cooper discusses the company’s three approaches to commercializing orphan drugs globally, and how to go from topline data to regulatory filing in 70 days.
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Scouting Turbulence For Opportunity7/1/2022
With bad news in the headlines at home and globally, and a seesawing public market capable of wiping years of value from company books almost overnight, it can be difficult to remain focused on the bread-and-butter tasks that keep a company afloat.
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Leveling Up By Challenging Assumptions6/1/2022
An outspoken champion of gender equity and diversity in the workplace, Arcellx CEO Rami Elghandour aims to put the company’s controllable CAR-T therapies on the cover of Time magazine.
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From Summer Stroll To Summer Hustle6/1/2022
As news reporter covering the biopharmaceutical industry in the early aughts, the summer months could present a different kind of challenge.
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3 Approaches For Developing Better Drugs To Treat Brain Disorders6/1/2022
Three organizations pursuing three different strategies for new drug development have one thing in common: optimism about the future of treatments for intractable brain disorders.
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A New Golden Age Of Psychedelic Therapy? Proceed With Caution5/2/2022
Is it time to stop worrying and love the drugs? Psychedelic medicines promise a radical solution to endemic mental health conditions, but caution is needed to cross the finish line.
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A New Model For A New Era Of Psychedelic Therapy5/2/2022
MAPS Public Benefit Corporation hopes to kick off the next golden age of psychedelic therapy with the potential FDA approval of its MDMA candidate for PTSD.