An Indiana Hoosiers fan, news junkie, health care journalist @PharmaPinkSheet, @IUBloomington alum, and soon a novelist. Opinions are my own.
Maryland
Joined October 2008
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Derrick retweeted
The US FDA seeks up to 10 drug-sponsor pairs with outside institutions for its new Expedited Investigational New Drug Pilot, which could include academic medical centers, contract research organizations, health care networks and regulatory advisors.
insights.citeline.com/pink-s…
Derrick retweeted
Alcon, Astellas Pharma, BeOne Medicines, BridgeBio, CSL, Kyowa Kirin, Sun Pharma, Teva Pharmaceuticals, and UCB signs MFN deals: whitehouse.gov/fact-sheets/2…
Derrick retweeted
Takeda’s Orzeyful (oveporexton) approved for narcolepsy type 1
For the first time, a medicine has been approved for narcolepsy type 1 as a complete disorder — targeting the biology behind it, not just its symptoms.
Narcolepsy type 1 affects ~1 in 2,000 Americans and causes debilitating symptoms that touch every part of daily life. Today's approval means patients now have a therapy that addresses the full constellation of those symptoms.
This treatment received both Breakthrough Therapy Designation and Priority Review — two FDA programs designed to bring transformative medicines to patients faster. fda.gov/news-events/press-an…
Derrick retweeted
HHS Considering US FDA Reorganization With Medical Products Chief Overseeing Centers insights.citeline.com/pink-s…
Derrick retweeted
Health Canada is offering sponsors a no-consequences clinical trial inspection before its E6(R3) deadline.
No rating. No report. No CAPA.
But proportionate doesn't mean minimal - and regulators already know the difference.
Derrick retweeted
US FDA Deputy CMO Mundkur, Acting CIO Mantha Resign, Adding To Post-Makary Leadership Exodus insights.citeline.com/pink-s…
Derrick retweeted
CMS has created a new Office of Health Technology and Products: public-inspection.federalreg…
Derrick retweeted
FDA offers new tables of examples of CDER (48) and CBER (9) approvals that included real world evidence (e.g. Medicare claims data) fda.gov/science-research/rea…
Derrick retweeted
CNPV Public Meeting Questions: US FDA Seeks Talking Points Before Confirming Speakers insights.citeline.com/pink-s…
Derrick retweeted
US FDA’s Tracy Beth Høeg Expected To Depart CDER insights.citeline.com/pink-s…
Derrick retweeted
“To our career staff, you hold the public trust, I respect your judgement and your dedication to the mission as we navigate this transition together,” FDA acting Commissioner Kyle Diamantas said in his email to staff today.
Derrick retweeted
FDA Commissioner Martin Makary testifying at Senate Approps next week: appropriations.senate.gov/he…
Derrick retweeted
NEW: The Pittsburgh Post-Gazette will continue publishing! It has been acquired by the nonprofit Venetoulis Institute, which runs the Baltimore Banner. My story here: nytimes.com/2026/04/14/busin…
Derrick retweeted
Today's the last day the FDA is accepting applications to be the next Director of its vaccine and biologics division, the Center for Biologics Evaluation and Research.
The post is currently held by Vinay Prasad, who is set to step down last this month:
usajobs.gov/job/862056100
Derrick retweeted
The One-Day FDA: US Commissioner Sees Drastic Time Savings In Filing, Inspections — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/4wza7 vist.ly/4wza8
Derrick retweeted
FDA issued a warning letter to $IBRX about "false and misleading" statements regarding Anktiva made by @DrPatrick on the Sean Spicer TV show.
fda.gov/inspections-complian…
h/t @AlecGaffney for spotting first.
Derrick retweeted
FDA is officially looking to hire a new Director of its Center for Biologics Evaluation and Research (CBER), and now you can see the full list of qualifications.
Would replace the outgoing director, Vinay Prasad, who is leaving at the end of April.
The agency is also looking for a second Deputy Director of CBER : (usajobs.gov/job/860827200)
We haven't yet seen FDA post about hiring a new Chief Scientific/Medical Officer, which is the other position held by Prasad.
Are you ready to shape the future of public health at the highest levels?
The FDA is seeking an exceptional executive leader to serve as the Center Director for CBER—a role at the forefront of regulating life-saving biological products, vaccines, and emerging therapies.
This is an opportunity to protect and advance public health on a national scale. You'll work on cutting-edge science, shape critical regulatory policy, and lead a team dedicated to ensuring the safety and effectiveness of biological products that save lives.
Apply by April 3, 2026. #FDAJobs
usajobs.gov/job/862056100?_g…
Derrick retweeted
The Interagency Autism Coordinating Committee meeting originally scheduled for March 19 has been postponed. We recognize the importance of the committee’s work and the strong interest from the autism community in this meeting. We are actively working to reschedule and will share additional information as it becomes available.
Derrick retweeted
US FDA COO Butler Retiring, Among First Of Makary’s Senior Team To Depart — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/4tr29 vist.ly/4tr2a
Derrick retweeted
‘This Can Be Weaponized’ – Sandoz Sounds Alarm Over Cheap Chinese Antibiotics — Click the image below to read more! || #InVivo | Start your free trial today: vist.ly/4tes5 vist.ly/4tes6