Derrick (@dgingery) profile picture

Derrick

@dgingery

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

 Maryland
derrickgingery.blogspot.com
Joined October 2008
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Maaisha Osman (@MaaishaO) profile picture
Maaisha Osman@MaaishaO17h
Senate Committee To Vote On US FDA Commissioner Nominee Before Dem Takeover insights.citeline.com/pink-s…
Senate Committee To Vote On US FDA Commissioner Nominee Before Dem Takeover

Senate Committee To Vote On US FDA Commissioner Nominee Before Dem Takeover

Outgoing Senate Health, Education, Labor and Pensions Committee Chair Bill Cassidy is planning a vote on Heidi Overton's nomination for FDA commissioner, while Acting Commissioner Kyle Diamantas'...

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For your GLP-1 radar ... @PharmaPinkSheet: GLP-1 Class Warning On Rare Eye Condition Driven By US FDA Meta-Analysis, Sentinel Study insights.citeline.com/pink-s…
GLP-1 Class Warning On Rare Eye Condition Driven By US FDA Meta-Analysis, Sentinel Study

GLP-1 Class Warning On Rare Eye Condition Driven By US FDA Meta-Analysis, Sentinel Study

FDA is requiring product labels for the diabetes and obesity products to add language in the warnings and precautions section about the potential increased risk of non-arteritic anterior ischemic...

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Interesting ... @PharmaPinkSheet: US FDA Probes Tumor Risk With Novartis’ Zolgensma And Itvisma After Gene Integration Reports insights.citeline.com/pink-s…
US FDA Probes Tumor Risk With Novartis’ Zolgensma And Itvisma After Gene Integration Reports

US FDA Probes Tumor Risk With Novartis’ Zolgensma And Itvisma After Gene Integration Reports

Agency says benefits still outweigh risks but is weighing regulatory action and reviewing whether labeling and long-term follow-up are adequate.

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For your gene therapy radar ... @PharmaPinkSheet: US FDA Defines Risk-Based Potency Approach To Cell and Gene Therapy insights.citeline.com/pink-s…
US FDA Defines Risk-Based Potency Approach To Cell and Gene Therapy

US FDA Defines Risk-Based Potency Approach To Cell and Gene Therapy

Final guidance asks CGT manufacturers to plan for potency from early product characterization through commercialization. Stakeholder webinar set for Dec. 10.

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The latest detail on FDA hiring and departures. One of my @PharmaPinkSheet stories with graphics! US FDA Biologics Center Joins Hiring Binge, Posts First Net Gain Since Pre-Trump Administration insights.citeline.com/pink-s…
US FDA Biologics Center Joins Hiring Binge, Posts First Net Gain Since Pre-Trump Administration

US FDA Biologics Center Joins Hiring Binge, Posts First Net Gain Since Pre-Trump Administration

The FDA drugs center also posted another positive hiring quarter as agency-wide employment continued to rise at the end of September.

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More from the Medicare price negotiation final rule from @PharmaPinkSheet's @MaaishaO: One-time treatments count as a year's worth ... CMS Retains ‘Value Of 12’ For One-Time Therapies In Medicare Price Negotiation Despite Pushback insights.citeline.com/pink-s…
CMS Retains ‘Value Of 12’ For One-Time Therapies In Medicare Price Negotiation Despite Pushback

CMS Retains ‘Value Of 12’ For One-Time Therapies In Medicare Price Negotiation Despite Pushback

CMS decided a one-dose gene therapy counts as just a year of treatment when its price is compared with monthly drugs, which industry said makes durable cures look far more expensive.

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You can ask for more @FDA ad/promo advisory comments after an initial round to add clarity, @PharmaPinkSheet @PinkSheetSutter reports ... Ad/Promo: Multiple US FDA Advisory Comment Requests OK, But Know Their Limits insights.citeline.com/pink-s…
Ad/Promo: Multiple US FDA Advisory Comment Requests OK, But Know Their Limits

Ad/Promo: Multiple US FDA Advisory Comment Requests OK, But Know Their Limits

Submitting promotional pieces to the Office of Prescription Drug Promotion for advisory comments, and then seeking further advice, is one of the best ways to avoid an enforcement letter, acting...

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Agree with this assessment
Alexander Gaffney (@AlecGaffney) profile pictureAlexander Gaffney
@AlecGaffneyNov 6
politico.com/news/2026/11/06… This is going to have reverberations throughout government.
Stephen Miller will replace Susie Wiles as White House chief of staff

Stephen Miller will replace Susie Wiles as White House chief of staff

politico.com
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Industry is looking forward to the new Congress already ... @PharmaPinkSheet: MFN Revisions, Codification Unlikely In Divided US Government, Pfizer’s Bourla Suggests insights.citeline.com/pink-s…
MFN Revisions, Codification Unlikely In Divided US Government, Pfizer’s Bourla Suggests

MFN Revisions, Codification Unlikely In Divided US Government, Pfizer’s Bourla Suggests

However, Bourla acknowledged Democrats likely will investigate aspects of the MFN deals when they take control in Congress.

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For your supply chain security and regulation radar ... @PharmaPinkSheet @MaaishaO: US FDA Creates Cross-Product Supply Chain Council In New Office Of National Health Security insights.citeline.com/pink-s…
US FDA Creates Cross-Product Supply Chain Council In New Office Of National Health Security

US FDA Creates Cross-Product Supply Chain Council In New Office Of National Health Security

An FDA official said the new council will coordinate supply chain work across product areas, but visibility will vary by product and proprietary information will limit transparency.

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Still amazed at how much sway NAD, a self-regulatory forum, has in pharma advertising. @PharmaPinkSheet's @PinkSheetSutter's story on another brand pharma win: Telehealth Company’s Personalized ‘Tirzepatide+’ Claims Ruled Unsupported In Lilly Challenge insights.citeline.com/pink-s…
Telehealth Company’s Personalized ‘Tirzepatide+’ Claims Ruled Unsupported In Lilly Challenge

Telehealth Company’s Personalized ‘Tirzepatide+’ Claims Ruled Unsupported In Lilly Challenge

The National Advertising Division said Good Life Meds lacked competent and reliable scientific evidence supporting its health benefit claims about tirzepatide when compounded with certain cofactors...

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The finalized Medicare price negotiation rule came out last night. @PharmaPinkSheet's @MaaishaO with the first write-through ... CMS Finalizes Combo Drug Policy As Botox Ruling Clouds Negotiation Authority insights.citeline.com/pink-s…
CMS Finalizes Combo Drug Policy As Botox Ruling Clouds Negotiation Authority

CMS Finalizes Combo Drug Policy As Botox Ruling Clouds Negotiation Authority

CMS finalized its combination drug policy, saying it closes a loophole, soon after a court scrambled its product price negotiation selection policy.

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My @PharmaPinkSheet story on the @FDA losing its chief counsel and what that could foreshadow ... Another Midterm Wave Coming? US FDA Chief Counsel Announces Departure insights.citeline.com/pink-s…
Another Midterm Wave Coming? US FDA Chief Counsel Announces Departure

Another Midterm Wave Coming? US FDA Chief Counsel Announces Departure

Sean Keveney agreed to stay in the job until a successor is found and a transition is completed, but he could be one of several political appointees to leave the agency.

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More from @PharmaPinkSheet's @MaaishaO on the impact of the midterm elections on the @FDA: US FDA Acting Chief Of Staff Sees Stable User Fee Path Despite Democrats’ Capitol Hill Takeover insights.citeline.com/pink-s…
US FDA Acting Chief Of Staff Sees Stable User Fee Path Despite Democrats’ Capitol Hill Takeover

US FDA Acting Chief Of Staff Sees Stable User Fee Path Despite Democrats’ Capitol Hill Takeover

The FDA’s acting chief of staff said the user fee programs are on solid footing after the midterms and outside experts expect Democratic gains should ease passage by shrinking holdout leverage and...

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Botox and Medicare price negotiation in the same story. How is that possible? Read on in the @PharmaPinkSheet: Botox Court Defeat Prompts CMS To Seek Legal Clarity On Price Negotiation Authority insights.citeline.com/pink-s…
Botox Court Defeat Prompts CMS To Seek Legal Clarity On Price Negotiation Authority

Botox Court Defeat Prompts CMS To Seek Legal Clarity On Price Negotiation Authority

AbbVie’s victory in a lawsuit over the selection of Botox for Medicare price negotiation is the first by a major manufacturer and could lay the groundwork for whittling away the agency’s discretion...

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More PBM reform issues ... @PharmaPinkSheet: Closing Loopholes: US Labor Department PBM Fee Transparency Rule Aims To Prevent Gaming insights.citeline.com/pink-s…
Closing Loopholes: US Labor Department PBM Fee Transparency Rule Aims To Prevent Gaming

Closing Loopholes: US Labor Department PBM Fee Transparency Rule Aims To Prevent Gaming

Drug pricing experts are cautiously optimistic that the rule will engage large employers in countering questionable pharmacy benefit manager practices that disadvantage enrollees.

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Interesting ... @PharmaPinkSheet: Oncology PRO Assessment Timing May Need To Evolve, US FDA Says insights.citeline.com/pink-s…
Oncology PRO Assessment Timing May Need To Evolve, US FDA Says

Oncology PRO Assessment Timing May Need To Evolve, US FDA Says

Oncology Center of Excellence official suggests that patient-reported outcomes may need to be collected more frequently early in treatment and for a longer duration, which means the pacing recommen...

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The @PharmaPinkSheet's quick first take on the election impact on the @FDA ... Democratic Wins In Congress Will Fuel MFN, FDA Oversight, May Advance Bipartisan Legislation insights.citeline.com/pink-s…
Democratic Wins In Congress Will Fuel MFN, FDA Oversight, May Advance Bipartisan Legislation

Democratic Wins In Congress Will Fuel MFN, FDA Oversight, May Advance Bipartisan Legislation

Near-term legislative opportunities are limited, but with a Senate majority and projected control of the House, Democrats are poised to flex their oversight and investigation powers and delay or...

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I wonder which nominees will be selected ... @PharmaPinkSheet: ACIP Seeks New Members, Suggesting Resurgence In 2027 insights.citeline.com/pink-s…
ACIP Seeks New Members, Suggesting Resurgence In 2027

ACIP Seeks New Members, Suggesting Resurgence In 2027

Despite its legal issues, HHS still can appoint ACIP members and wants nominations by Dec. 31.

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A big question remains whether the framework initiative can fix the issues that have lingered for years ... @PharmaPinkSheet @RPMReportMike: From Flexibility To Framework: US FDA Still Searching For Right Rare Disease Message insights.citeline.com/pink-s…
From Flexibility To Framework: US FDA Still Searching For Right Rare Disease Message

From Flexibility To Framework: US FDA Still Searching For Right Rare Disease Message

The FDA’s Rare Disease Framework initiative is the latest effort to address rare disease advocates’ concerns about a misalignment between traditional safety and efficacy expectations and the realit...

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