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The Pink Sheet Daily
Number of Followers: 2

Full-text available via subscription

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ISSN (Print) 1554-4036
Published by Informa plc

[9 journals]

Pink Sheet Podcast: CAR-T Malignancy Reports, Background Music In DTC Ads,
New No. 2 At US FDA
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  Abstract: Pink Sheet reporter and editors discuss the FDA acknowledging reports of malignancies in patients who received CAR-T cell immunotherapies, the... Related Stories
  US FDA’s Patient-Focused Drug Development Program Meetings Evolve With Technology Focus
  US FDA’s Patient-Focused Drug Development Program Evolving To Focus Meetings On Technology Instead Of Disease
  Japan’s CEA Scheme: How It Works And Impact So Far
  PubDate: Fri, 01 Dec 2023 14:38:40 GMT
‘Vast Amount Of Valuable Input’ Leads Australia To Extend HTA
Review
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  Abstract: A second public consultation on the review of the HTA system will be held in January to February 2024 after... Related Stories
  French Regulator At Odds With EMA Over Safety Restrictions For Pseudoephedrine
  Premature Filings Add To EU Regulatory Resource Challenge
  EU Parliament Says Pharma IP & Trade Secrets Must Be Protected Under Health Data Space
  PubDate: Fri, 01 Dec 2023 12:33:18 GMT
French Regulator At Odds With EMA Over Safety Restrictions For
Pseudoephedrine
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  Abstract: The product information for all pseudoephedrine-containing medicines in the EU will need to be updated, the European Medicines Agency said... Related Stories
  ‘Vast Amount Of Valuable Input’ Leads Australia To Extend HTA Review
  Premature Filings Add To EU Regulatory Resource Challenge
  EU Parliament Says Pharma IP & Trade Secrets Must Be Protected Under Health Data Space
  PubDate: Fri, 01 Dec 2023 12:20:29 GMT
US FDA’s Patient-Focused Drug Development Program Meetings Evolve
With Technology Focus
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  Abstract: A recent externally-led PFDD meeting on kidney xenotransplantation, rather than a specific disease, allowed for more tailored patient comments on... Related Stories
  Pink Sheet Podcast: CAR-T Malignancy Reports, Background Music In DTC Ads, New No. 2 At US FDA
  US FDA’s Patient-Focused Drug Development Program Evolving To Focus Meetings On Technology Instead Of Disease
  Japan’s CEA Scheme: How It Works And Impact So Far
  PubDate: Fri, 01 Dec 2023 11:47:28 GMT
Premature Filings Add To EU Regulatory Resource Challenge
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  Abstract: The pharmaceutical legislation overhaul offers some solutions to the problem of immature applications. Related Stories
  ‘Vast Amount Of Valuable Input’ Leads Australia To Extend HTA Review
  French Regulator At Odds With EMA Over Safety Restrictions For Pseudoephedrine
  EU Parliament Says Pharma IP & Trade Secrets Must Be Protected Under Health Data Space
  PubDate: Fri, 01 Dec 2023 11:44:38 GMT
EU Parliament Says Pharma IP & Trade Secrets Must Be Protected
Under Health Data Space
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  Abstract: The European Parliament has adopted changes to the proposed European Health Data Space that would protect the intellectual property of... Related Stories
  ‘Vast Amount Of Valuable Input’ Leads Australia To Extend HTA Review
  French Regulator At Odds With EMA Over Safety Restrictions For Pseudoephedrine
  Premature Filings Add To EU Regulatory Resource Challenge
  PubDate: Fri, 01 Dec 2023 10:39:44 GMT
Japan’s CEA Scheme: How It Works And Impact So Far
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  Abstract: Japan has announced the latest evaluation results under its cost effectiveness assessment scheme. But how does it work and how... Related Stories
  Pink Sheet Podcast: CAR-T Malignancy Reports, Background Music In DTC Ads, New No. 2 At US FDA
  US FDA’s Patient-Focused Drug Development Program Meetings Evolve With Technology Focus
  US FDA’s Patient-Focused Drug Development Program Evolving To Focus Meetings On Technology Instead Of Disease
  PubDate: Thu, 30 Nov 2023 16:46:35 GMT
US FDA’s Califf: Payers Should Ask How They Can Help Answer Clinical
Research Questions
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  Abstract: Instead of asking why confirmatory trials take so long, the FDA commissioner suggests insurance companies ask what they can do... Related Stories
  Pink Sheet Podcast: CAR-T Malignancy Reports, Background Music In DTC Ads, New No. 2 At US FDA
  US FDA’s Patient-Focused Drug Development Program Meetings Evolve With Technology Focus
  US FDA’s Patient-Focused Drug Development Program Evolving To Focus Meetings On Technology Instead Of Disease
  PubDate: Thu, 30 Nov 2023 16:37:21 GMT
EU Pharma Wants Regulators’ Help To Simplify Digital Endpoints
Landscape
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  Abstract: The European pharmaceutical industry federation, EFPIA, says its member companies are not looking for shortcuts to develop and validate digital... Related Stories
  ‘Vast Amount Of Valuable Input’ Leads Australia To Extend HTA Review
  French Regulator At Odds With EMA Over Safety Restrictions For Pseudoephedrine
  Premature Filings Add To EU Regulatory Resource Challenge
  PubDate: Thu, 30 Nov 2023 11:40:08 GMT
Partnerships Are Key To Sustainable mRNA Vaccine Production In LMICs
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  Abstract: Low- and middle-income countries need to have the know-how, capability and capacity to produce mRNA vaccines, from concept, design and... Related Stories
  ‘Vast Amount Of Valuable Input’ Leads Australia To Extend HTA Review
  French Regulator At Odds With EMA Over Safety Restrictions For Pseudoephedrine
  Premature Filings Add To EU Regulatory Resource Challenge
  PubDate: Thu, 30 Nov 2023 11:32:08 GMT
Early Advice Could Help Companies Maintain EU Conditional Marketing
Authorizations
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  Abstract: The number of conditional marketing authorization non-renewals could increase. Related Stories
  ‘Vast Amount Of Valuable Input’ Leads Australia To Extend HTA Review
  French Regulator At Odds With EMA Over Safety Restrictions For Pseudoephedrine
  Premature Filings Add To EU Regulatory Resource Challenge
  PubDate: Thu, 30 Nov 2023 11:31:42 GMT
MSD & Kyowa Question NICE’s Processes After English Funding Rejected
For Rare Disease Drugs
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  Abstract: MSD and Kyowa Kirin have separately criticized England’s HTA body, NICE, for assessing their respective rare disease medicines Welireg and... Related Stories
  ‘Vast Amount Of Valuable Input’ Leads Australia To Extend HTA Review
  French Regulator At Odds With EMA Over Safety Restrictions For Pseudoephedrine
  Premature Filings Add To EU Regulatory Resource Challenge
  PubDate: Thu, 30 Nov 2023 11:11:30 GMT
Drug Candidates For NASH & Epilepsy Disorder Secure EMA PRIME
Designations
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  Abstract: The developers of survodutide and elsunersen will be able to benefit from the early and enhanced support that the European... Related Stories
  ‘Vast Amount Of Valuable Input’ Leads Australia To Extend HTA Review
  French Regulator At Odds With EMA Over Safety Restrictions For Pseudoephedrine
  Premature Filings Add To EU Regulatory Resource Challenge
  PubDate: Thu, 30 Nov 2023 10:47:59 GMT
Pragmatic Oncology Trials: Survival Is Only Viable Endpoint For Now; FDA
Emphasizes Streamlining
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  Abstract: Overall survival is the only viable endpoint for pragmatic trials in oncology, the US FDA and a panel of stakeholders... Related Stories
  Pink Sheet Podcast: CAR-T Malignancy Reports, Background Music In DTC Ads, New No. 2 At US FDA
  US FDA’s Patient-Focused Drug Development Program Meetings Evolve With Technology Focus
  US FDA’s Patient-Focused Drug Development Program Evolving To Focus Meetings On Technology Instead Of Disease
  PubDate: Wed, 29 Nov 2023 18:58:18 GMT
New Korea Commission Needs Status To Function As Control Tower: Industry
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  Abstract: A policy report by a major South Korean pharma industry association puts forward suggestions on what it will take for... Related Stories
  Pink Sheet Podcast: CAR-T Malignancy Reports, Background Music In DTC Ads, New No. 2 At US FDA
  US FDA’s Patient-Focused Drug Development Program Meetings Evolve With Technology Focus
  US FDA’s Patient-Focused Drug Development Program Evolving To Focus Meetings On Technology Instead Of Disease
  PubDate: Wed, 29 Nov 2023 18:43:38 GMT
US FDA Chief Scientist Bumpus Will Become Principal Deputy Commissioner
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  Abstract: When Janet Woodcock retires early next year, Namandjé Bumpus will take over as No. 2 in command at the FDA... Related Stories
  Pink Sheet Podcast: CAR-T Malignancy Reports, Background Music In DTC Ads, New No. 2 At US FDA
  US FDA’s Patient-Focused Drug Development Program Meetings Evolve With Technology Focus
  US FDA’s Patient-Focused Drug Development Program Evolving To Focus Meetings On Technology Instead Of Disease
  PubDate: Wed, 29 Nov 2023 18:26:52 GMT
Gene Therapies Without Randomized Clinical Trials: Marks Outlines Rare
Disease Development Path
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  Abstract: A single-arm trial using a biomarker and animal model could be enough for an accelerated approval, especially in a pediatric... Related Stories
  Pink Sheet Podcast: CAR-T Malignancy Reports, Background Music In DTC Ads, New No. 2 At US FDA
  US FDA’s Patient-Focused Drug Development Program Meetings Evolve With Technology Focus
  US FDA’s Patient-Focused Drug Development Program Evolving To Focus Meetings On Technology Instead Of Disease
  PubDate: Wed, 29 Nov 2023 17:40:13 GMT
Copay Accumulators Get A Reprieve: Commercial Plans’ Use Will Not Be
Restricted By CMS – Yet
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  Abstract: US Health and Human Service Department questions recent federal court decision striking down the government’s policy of allowing plans to... Related Stories
  ‘Vast Amount Of Valuable Input’ Leads Australia To Extend HTA Review
  French Regulator At Odds With EMA Over Safety Restrictions For Pseudoephedrine
  Premature Filings Add To EU Regulatory Resource Challenge
  PubDate: Wed, 29 Nov 2023 16:35:21 GMT
Qualifying Digital Biomarkers ‘Much Easier Now’ Thanks To EMA
Efforts
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  Abstract: The European Medicines Agency has been on a steep learning curve with its qualification of a digitally-measured outcome for use... Related Stories
  ‘Vast Amount Of Valuable Input’ Leads Australia To Extend HTA Review
  French Regulator At Odds With EMA Over Safety Restrictions For Pseudoephedrine
  Premature Filings Add To EU Regulatory Resource Challenge
  PubDate: Wed, 29 Nov 2023 12:29:23 GMT
EMA Expands Early Engagement With Patients & Health Professionals
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  Abstract: On the back of a successful pilot of early consultations with patients, the European Medicines Agency is extending the initiative... Related Stories
  ‘Vast Amount Of Valuable Input’ Leads Australia To Extend HTA Review
  French Regulator At Odds With EMA Over Safety Restrictions For Pseudoephedrine
  Premature Filings Add To EU Regulatory Resource Challenge
  PubDate: Wed, 29 Nov 2023 11:43:42 GMT