Derrick

@dgingery

An Indiana Hoosiers fan, news junkie, health care journalist @PharmaPinkSheet, @IUBloomington alum, and soon a novelist. Opinions are my own.

Maryland

Joined October 2008

846Following

1KFollowers

Pinned

Derrick@dgingery · Jul 25

Listen as @PharmaPinkSheet's @SarahKarlin, @PinkSheetHobbs and I talk the new @US_FDA CDER director and Sarepta's issues. NO PAYWALL! insights.citeline.com//pink-sheet/po…

dgingery's tweet card. Pink Sheet reporter and editors discuss the potential impact George Tidmarsh could have as director of the US FDA Center for Drug Evaluation and Research and the issues threatening the future of...

317

Pinned

Derrick@dgingery · Jul 25

This is a big concern for the @US_FDA. @PharmaPinkSheet's @SarahKarlin reports on cancer drug reviewers leaving the agency ... US FDA Cancer Reviewers Heading For The Exits, Potentially Impacting Review Timelines insights.citeline.com//pink-sheet/ag…

dgingery's tweet card. US FDA's cancer drugs division is feeling the effect of drug reviewer departures, despite efforts to keep them at the agency.

Pinned

Derrick@dgingery · Jul 25

One of my stories for @PharmaPinkSheet. @US_FDA's CBER lost more than 100 people after the RIF, but another more than 100 from Jan. 1 to June 30: US FDA’s Biologics Center Departures Grew Before More Than 100 RIFs Exited insights.citeline.com//pink-sheet/ag…

dgingery's tweet card. The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-...

Pinned

Derrick@dgingery · Jul 25

Wow, even a year reprieve can cost billions in lost savings. Something to consider ... @PharmaPinkSheet: Merck’s Keytruda Gains Medicare Negotiation Reprieve With Expanded Orphan Exemption insights.citeline.com//pink-sheet/ma…

dgingery's tweet card. Bristol Myers Squibb’s Opdivo and Merck's Welireg also could benefit from the delay in Medicare price negotiation process eligibility.

Pinned

Derrick@dgingery · Jul 24

An interesting take on @US_FDA leadership from @RPMReportMike for @PharmaPinkSheet: US FDA Commissioner Makary Is Learning To Appreciate His Staff insights.citeline.com//pink-sheet/ag…

dgingery's tweet card. After three months on the job, FDA Commissioner Martin Makary is sounding much more effusive about the quality of the agency staff. Better late than never?

Pinned

Derrick@dgingery · Jul 24

I'm curious to see how this idea works ... @PharmaPinkSheet on an effort to control 340B discounts: 340B Transparency: CMS Proposes Claims Repository For Medicare Part D Drugs insights.citeline.com//pink-sheet/ma…

dgingery's tweet card. The plan was announced as the White House Office of Management and Budget discusses with stakeholders a widely anticipated guidance about the 340B rebate model, which is being advanced by manufactu...

Pinned

Derrick@dgingery · Jul 24

The Blenrep AC included a "Pazdur moment" ... a reminder that applicability to US patients remains important. The @PharmaPinkSheet story by @PinkSheetSutter: Blenrep Review Highlights US FDA Oncology Trial Site Selection, Comparator Issues insights.citeline.com//pink-sheet/pr…

dgingery's tweet card. The FDA will take a hard line on trial design and site selection to ensure applicability to the US, Oncology Center of Excellence Director Richard Pazdur said during a meeting on GSK's Blenrep.

101

Pinned

Derrick@dgingery · Jul 23

Is there a chance to enact a stand-alone PBM reform package? Maybe ... @PharmaPinkSheet @AISHealth: Advocates Want New Bipartisan PBM Reform Package To Stand Alone insights.citeline.com//pink-sheet/ma…

dgingery's tweet card. A new PBM reform package has familiar provisions, but stakeholders want it to move as a stand-alone bill, rather than as part of a larger legislative vehicle.

Pinned

Derrick@dgingery · Jul 23

If the @US_FDA convened an adcomm to discuss Elevidys' safety issues, I think it would be pretty well attended. One of my and @ScripMandy's stories for the @PharmaPinkSheet: After Sarepta Reversed Course On Elevidys, Could An Adcomm Be Next? insights.citeline.com//pink-sheet/pr…

dgingery's tweet card. One option for the FDA going forward could be holding an advisory committee meeting on its safety concerns after Sarepta agreed to stop all shipments of its DMD gene therapy.

185

Pinned

Derrick@dgingery · Jul 23

Is @US_FDA changing its regulatory approach to regenerative medicine? The @PharmaPinkSheet has the story ... Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation insights.citeline.com//pink-sheet/pr…

dgingery's tweet card. Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about...

Pinned

Derrick@dgingery · Jul 22

An interesting comparison ... @PharmaPinkSheet: ‘Prescription Drugs Are Not Golf Balls’: FTC/DoJ Solicit Clashing Opinions On Patents insights.citeline.com//pink-sheet/le…

dgingery's tweet card. Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?

Pinned

Derrick@dgingery · Jul 22

Interesting look at yesterday's @US_FDA SSRI meeting from @PharmaPinkSheet's @PinkSheetSutter. Wonder when we'll start seeing changes sparked by this and other similar mtgs? US FDA Could Seek Stronger Warnings On SSRI Antidepressant Risks During Pregnancy insights.citeline.com//pink-sheet/dr…

dgingery's tweet card. Testimony during a July 21 ‘expert panel’ could help justify stronger warnings across the class about potential adverse effects on mother and baby. Panelists ranged from clinicians who said depress...

Pinned

Derrick Retweeted

Pink Sheet, Citeline Regulatory@PharmaPinkSheet · Jul 21

The US Food and Drug Administration’s Center for Drug Evaluation and Research has appointed a new director. | #PinkSheet || vist.ly/3ymep || Start your free trial today: vist.ly/3ymer vist.ly/3ymeq

204

Pinned

Derrick@dgingery · Jul 21

An interesting look at the drugs that could be impacted by the cuts in the big beautiful bill ... @PharmaPinkSheet: Biktarvy, Trikafta Affected As Medicaid Cuts Could Increase Patient Assistance Demands insights.citeline.com//pink-sheet/ma…

dgingery's tweet card. Patient access to mental health drugs also will be challenged by the policies in the new budget reconciliation legislation.

Pinned

Derrick@dgingery · Jul 21

What's the over-under on how long this stand-off lasts? @PharmaPinkSheet @ScripMandy: Sarepta Refuses To Stop Elevidys Shipments After Third Death Linked To Gene Therapy Vector insights.citeline.com//pink-sheet/ad…

dgingery's tweet card. Sarepta knew about the death in a Phase I trial of SRP-9004 for LGMD when it recently revealed a restructuring plan, but did not disclose the event. The now-discontinued gene therapy candidate uses...

312

Pinned

Derrick@dgingery · Jul 21

Rexulti didn't do well at its adcomm last week @PharmaPinkSheet ... Don’t Look Back: US FDA AdComm Offers No Flexibility For Rexulti’s Post Hoc Bid In PTSD insights.citeline.com//pink-sheet/pr…

dgingery's tweet card. The US FDA's Psychopharmacology Advisory Committee emphasized high standards over regulatory flexibility while turning down Otsuka's brexpiprazole plus serotonin for post-traumatic stress disorder...

Pinned

Derrick Retweeted

Pink Sheet, Citeline Regulatory@PharmaPinkSheet · Jul 18

Pink Sheet Podcast: CBER Director’s Political Spin On COVID-19 Vaccines And US FDA RIFs Finalized — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/3yedg vist.ly/3yedh

172

Derrick@dgingery · Jul 22

Turns out it only took 3 days... @ScripMandy

MMandy Jackson@ScripMandy · Jul 22

$SRPT Voluntarily pausing all shipments of DMD gene therapy Elevidys in the US because “ it became obvious that maintaining [a] productive working relationship required this temporary suspension while we address any questions that FDA may have …” investorrelations.sarepta.com/news-releases/…