Pink Sheet, Citeline Regulatory

@PharmaPinkSheet

Pink Sheet delivers analysis & commentary focused on regulatory implications, including high value perspectives from insiders & thought leaders across the globe

Global

Joined December 2012

335Following

6KFollowers

Pinned

Pink Sheet, Citeline Regulatory@PharmaPinkSheet · Jul 26

Real-Time Release Of CRLs Is US FDA’s Goal, Agency Leaders Affirm — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/3z8hu vist.ly/3z8hv

PharmaPinkSheet's tweet card. The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal...

150

Pinned

Pink Sheet, Citeline Regulatory@PharmaPinkSheet · Jul 25

No Surprise Here: Foreign Drug Facilities Should Expect Surprise Inspections, US FDA Says — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/3z8ez vist.ly/3z8e2

PharmaPinkSheet's tweet card. The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced,...

142

Pinned

Pink Sheet, Citeline Regulatory@PharmaPinkSheet · Jul 25

Base Benefit-Risk Decisions On Data, Not Opinion And Passion, CDER’s Tidmarsh Says — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/3z8bt vist.ly/3z8bu

PharmaPinkSheet's tweet card. New US FDA drugs center director George Tidmarsh’s data-centric comments at a Reagan-Udall Foundation meeting on unapproved fluoride products could suggest patients’ and caregivers’ experiences will...

302

Pinned

Pink Sheet, Citeline Regulatory@PharmaPinkSheet · Jul 25

Pink Sheet Podcast: FDA’s New Top Drug Regulator, Sarepta’s Options After Elevidys Stand-Off — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/3z7sw vist.ly/3z7sx

PharmaPinkSheet'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...

250

Pinned

Pink Sheet, Citeline Regulatory@PharmaPinkSheet · Jul 25

EMA Says ‘No’ To Roche/Sarepta’s DMD Gene Therapy Elevidys — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/3z7kd vist.ly/3z7ke

PharmaPinkSheet's tweet card. The European Medicines Agency has recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy, despite the product...

236

Pinned

Pink Sheet, Citeline Regulatory@PharmaPinkSheet · Jul 25

EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/3z7c8 vist.ly/3z7c9

PharmaPinkSheet's tweet card. The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

150

Pinned

Pink Sheet, Citeline Regulatory@PharmaPinkSheet · Jul 25

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/3z6wr vist.ly/3z6ws

PharmaPinkSheet's tweet card. The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.

107

Pinned

Pink Sheet, Citeline Regulatory@PharmaPinkSheet · Jul 25

US FDA’s Biologics Center Departures Grew Before More Than 100 RIFs Exited — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/3z4ir vist.ly/3z4is

PharmaPinkSheet'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-...

174

Pinned

Pink Sheet, Citeline Regulatory@PharmaPinkSheet · Jul 25

Merck’s Keytruda Gains Medicare Negotiation Reprieve With Expanded Orphan Exemption — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/3z4gs vist.ly/3z4gt

192

Pinned

Pink Sheet, Citeline Regulatory@PharmaPinkSheet · Jul 24

US FDA Cancer Reviewers Heading For The Exits, Potentially Impacting Review Timelines — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/3z4e4 vist.ly/3z4e5

PharmaPinkSheet'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.

119

Pinned

Pink Sheet, Citeline Regulatory@PharmaPinkSheet · Jul 24

EU’s Life Sciences Strategy Faces Race Against Time, Says Clinical Trials Community — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/3z3jc vist.ly/3z3jd

PharmaPinkSheet's tweet card. EU’s Life Sciences Strategy Faces Race Against Time, Says Clinical Trials Community

142

Pinned

Pink Sheet, Citeline Regulatory@PharmaPinkSheet · Jul 24

Quotable: Top Experts On Policy Hot Topics — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/3z37u vist.ly/3z37v

PharmaPinkSheet's tweet card. The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

124

Pinned

Pink Sheet, Citeline Regulatory@PharmaPinkSheet · Jul 24

Australia Targets Clinical Trial Reform, AI Use & Drug Shortages In 12-Month Plan — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/3y2ta vist.ly/3y2tb

PharmaPinkSheet's tweet card. Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australi...

105

Pinned

Pink Sheet, Citeline Regulatory@PharmaPinkSheet · Jul 24

Leqembi Likely To Face 15% Price Cut In Japan — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/3yyby vist.ly/3yybz

PharmaPinkSheet's tweet card. Japan looks set to press ahead with a reimbursement price cut for Eisai's Alzheimer's drug Leqembi following a cost-effectiveness review, despite differences with the company over methodology.

156

Pinned

Pink Sheet, Citeline Regulatory@PharmaPinkSheet · Jul 24

340B Transparency: CMS Proposes Claims Repository For Medicare Part D Drugs — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/3yxzr vist.ly/3yxzs

PharmaPinkSheet'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...

168

Pinned

Pink Sheet, Citeline Regulatory@PharmaPinkSheet · Jul 23

US FDA Commissioner Makary Is Learning To Appreciate His Staff — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/3yxw9 vist.ly/3yxwa

PharmaPinkSheet'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?

134

Pinned

Pink Sheet, Citeline Regulatory@PharmaPinkSheet · Jul 23

Blenrep Review Highlights US FDA Oncology Trial Site Selection, Comparator Issues — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/3yxqz vist.ly/3yxq2

PharmaPinkSheet'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.

232

Pinned

Pink Sheet, Citeline Regulatory@PharmaPinkSheet · Jul 23

US Tariffs And The EU’s Critical Medicines Act: Lessons On Nearshoring And CMO Diversification — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/3yx9h vist.ly/3yx9i

PharmaPinkSheet's tweet card. Nearshoring production and diversifying contract manufacturing networks can help companies stave off cost increases that will be reflected in higher medicine prices.

124

Pinned

Pink Sheet, Citeline Regulatory@PharmaPinkSheet · Jul 23

EMA Poised To Decide On Fate Of Lilly’s Kisunla And PharmaMar’s Aplidin In EU — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/3ywcq vist.ly/3ywcr

PharmaPinkSheet's tweet card. Eli Lilly and PharmaMar were set to make their case before the European Medicines Agency this week as part of re-examination procedures for their respective drugs Kisunla and Aplidin.

711

Pinned

Pink Sheet, Citeline Regulatory@PharmaPinkSheet · Jul 23

Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/3ytpq vist.ly/3ytpr

PharmaPinkSheet'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...

168