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The Pink Sheet Daily
Number of Followers: 4

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ISSN (Print) 1554-4036
Published by Informa plc

[9 journals]

Korean Bioclusters Offer Tax, Other Incentives To Attract Global Firms,
Talent
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  Abstract: South Korea has formulated new detailed policy measures to support the formation of major bioclusters, which will offer tax and... Related Stories
  CDC Panel Backs Pfizer’s Maternal RSV Vaccine But Leaves Room For AstraZeneca/Sanofi’s Beyfortus
  EU Could Soon Have Three XBB.1.5 COVID-19 Vaccines For Winter Season
  NASH Drug Development: Experts Argue The Case For Noninvasive Tests As Surrogate Endpoints For Approval
  PubDate: Fri, 22 Sep 2023 20:41:03 GMT
CDC Panel Backs Pfizer’s Maternal RSV Vaccine But Leaves Room For
AstraZeneca/Sanofi’s Beyfortus
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  Abstract: Abrysvo is recommended for use in pregnant people 32-36 weeks gestation if administered from September to January. For infants whose... Related Stories
  Korean Bioclusters Offer Tax, Other Incentives To Attract Global Firms, Talent
  EU Could Soon Have Three XBB.1.5 COVID-19 Vaccines For Winter Season
  NASH Drug Development: Experts Argue The Case For Noninvasive Tests As Surrogate Endpoints For Approval
  PubDate: Fri, 22 Sep 2023 19:27:58 GMT
EU Could Soon Have Three XBB.1.5 COVID-19 Vaccines For Winter Season
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  Abstract: The head of the European Medicines Agency says a group of international regulators got together to ensure “global alignment” on... Related Stories
  Korean Bioclusters Offer Tax, Other Incentives To Attract Global Firms, Talent
  CDC Panel Backs Pfizer’s Maternal RSV Vaccine But Leaves Room For AstraZeneca/Sanofi’s Beyfortus
  NASH Drug Development: Experts Argue The Case For Noninvasive Tests As Surrogate Endpoints For Approval
  PubDate: Fri, 22 Sep 2023 11:46:45 GMT
EU Orphan Drug Law Reform Will See Innovation Drop By 12%, Industry Warns
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  Abstract: The European Commission’s proposals to overhaul the EU pharma legislation, which will see some orphan drug incentives cut, would cause... Related Stories
  Intarcia’s Implantable GLP-1 Gets Unanimous No Vote But Lots Of New Trial Design Advice
  US FDA's Cavazzoni Criticizes Plant Shutdown That Triggered Serious Cisplatin Shortage
  Pilot Phase Of Operation Warp Speed For Rare Diseases Beginning Soon
  PubDate: Fri, 22 Sep 2023 09:34:40 GMT
Intarcia’s Implantable GLP-1 Gets Unanimous No Vote But Lots Of New
Trial Design Advice
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  Abstract: US FDA advisory panel feels there could be a place for Intarcia’s exenatide drug-device combo – if the company is... Related Stories
  EU Orphan Drug Law Reform Will See Innovation Drop By 12%, Industry Warns
  US FDA's Cavazzoni Criticizes Plant Shutdown That Triggered Serious Cisplatin Shortage
  Pilot Phase Of Operation Warp Speed For Rare Diseases Beginning Soon
  PubDate: Thu, 21 Sep 2023 23:50:14 GMT
NASH Drug Development: Experts Argue The Case For Noninvasive Tests As
Surrogate Endpoints For Approval
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  Abstract: However, FDA officials appear skeptical that imaging-based and circulating biomarkers are ready for prime time when it comes to supporting... Related Stories
  Korean Bioclusters Offer Tax, Other Incentives To Attract Global Firms, Talent
  CDC Panel Backs Pfizer’s Maternal RSV Vaccine But Leaves Room For AstraZeneca/Sanofi’s Beyfortus
  EU Could Soon Have Three XBB.1.5 COVID-19 Vaccines For Winter Season
  PubDate: Thu, 21 Sep 2023 23:25:32 GMT
US FDA's Cavazzoni Criticizes Plant Shutdown That Triggered
Serious Cisplatin Shortage
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  Abstract: Director of the FDA’s center for drugs slams firm for failing to reach out before suspending operations in the wake... Related Stories
  EU Orphan Drug Law Reform Will See Innovation Drop By 12%, Industry Warns
  Intarcia’s Implantable GLP-1 Gets Unanimous No Vote But Lots Of New Trial Design Advice
  Pilot Phase Of Operation Warp Speed For Rare Diseases Beginning Soon
  PubDate: Thu, 21 Sep 2023 18:16:00 GMT
FDA Change In Bioequivalence Requirements Leads To Downgrade Of
Accord’s Generic Tacrolimus
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  Abstract: After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver... Related Stories
  Korean Bioclusters Offer Tax, Other Incentives To Attract Global Firms, Talent
  CDC Panel Backs Pfizer’s Maternal RSV Vaccine But Leaves Room For AstraZeneca/Sanofi’s Beyfortus
  EU Could Soon Have Three XBB.1.5 COVID-19 Vaccines For Winter Season
  PubDate: Thu, 21 Sep 2023 17:43:57 GMT
EU CHMP Opinions And MAA Updates
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  Abstract: This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the... Related Stories
  Additional Analyses Help Idorsia Secure English Funding For Chronic Insomnia Drug Quviviq
  Tackling AMR: OECD Says Greater Investment Needed In Later-Stage Drug R&D
  EMA Addresses Rapid Acting Therapies, Psychedelics In Updated Guidance On Depression Treatments
  PubDate: Thu, 21 Sep 2023 12:30:00 GMT
Dissent In Parliament As Commission Claims EU Pharma Revision Will Improve
Competitiveness and Access
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  Abstract: Proposals on regulatory data protection and transferable exclusivity vouchers to encourage antimicrobial R&D have received mixed reactions from the parliament’s... Related Stories
  Korean Bioclusters Offer Tax, Other Incentives To Attract Global Firms, Talent
  CDC Panel Backs Pfizer’s Maternal RSV Vaccine But Leaves Room For AstraZeneca/Sanofi’s Beyfortus
  EU Could Soon Have Three XBB.1.5 COVID-19 Vaccines For Winter Season
  PubDate: Thu, 21 Sep 2023 11:57:20 GMT
EU Group Facilitates Switching Multinational Trials To CTR
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  Abstract: Revisions to the updated EU guideline on transitioning multinational trials to the Clinical Trials Regulation are said to be “solution... Related Stories
  Korean Bioclusters Offer Tax, Other Incentives To Attract Global Firms, Talent
  CDC Panel Backs Pfizer’s Maternal RSV Vaccine But Leaves Room For AstraZeneca/Sanofi’s Beyfortus
  EU Could Soon Have Three XBB.1.5 COVID-19 Vaccines For Winter Season
  PubDate: Thu, 21 Sep 2023 11:48:00 GMT
As New Tech Emerges For Early Research, FDA Chief Scientist Says Diversity
Must Start In Preclinical Development
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  Abstract: In a Pink Sheet interview Chief Scientist Bumpus discusses need to move diversity conversation up further in the pipeline. Better... Related Stories
  EU Picks Up The Pace On Home Delivery Of Study Drugs
  Japan Takes New Steps To Build On Real-World Data Foundations
  Impasse At US FDA Could Mean Stealth Abandons Barth Syndrome Treatment
  PubDate: Wed, 20 Sep 2023 22:47:24 GMT
Pilot Phase Of Operation Warp Speed For Rare Diseases Beginning Soon
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  Abstract: US FDA’s biologics center intends to ask for volunteers to help demonstrate the concept, modeled on the COVID vaccine effort... Related Stories
  EU Orphan Drug Law Reform Will See Innovation Drop By 12%, Industry Warns
  Intarcia’s Implantable GLP-1 Gets Unanimous No Vote But Lots Of New Trial Design Advice
  US FDA's Cavazzoni Criticizes Plant Shutdown That Triggered Serious Cisplatin Shortage
  PubDate: Wed, 20 Sep 2023 21:13:54 GMT
Platform Technology Designation A Gene Therapy Opportunity, OTP Director
Verdun Says
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  Abstract: The new designation could streamline development of multiple products that use the same backbone, said Nicole Verdun, director of the... Related Stories
  EU Orphan Drug Law Reform Will See Innovation Drop By 12%, Industry Warns
  Intarcia’s Implantable GLP-1 Gets Unanimous No Vote But Lots Of New Trial Design Advice
  US FDA's Cavazzoni Criticizes Plant Shutdown That Triggered Serious Cisplatin Shortage
  PubDate: Wed, 20 Sep 2023 19:01:56 GMT
PBM Reforms: House Hearing Suggests Bipartisan Consensus On Legislative
Policies Has Limits
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  Abstract: There was lots of criticism of pharmacy benefit managers (and a fair amount of pharmaceutical manufacturers) at the oversight hearing... Related Stories
  EU Orphan Drug Law Reform Will See Innovation Drop By 12%, Industry Warns
  Intarcia’s Implantable GLP-1 Gets Unanimous No Vote But Lots Of New Trial Design Advice
  US FDA's Cavazzoni Criticizes Plant Shutdown That Triggered Serious Cisplatin Shortage
  PubDate: Wed, 20 Sep 2023 18:36:55 GMT
Additional Analyses Help Idorsia Secure English Funding For Chronic
Insomnia Drug Quviviq
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  Abstract: Quviviq is to become the first dual orexin receptor antagonist available on the National Health Service. Just over 20,000 people... Related Stories
  Korean Bioclusters Offer Tax, Other Incentives To Attract Global Firms, Talent
  CDC Panel Backs Pfizer’s Maternal RSV Vaccine But Leaves Room For AstraZeneca/Sanofi’s Beyfortus
  EU Could Soon Have Three XBB.1.5 COVID-19 Vaccines For Winter Season
  PubDate: Wed, 20 Sep 2023 11:31:11 GMT
Tackling AMR: OECD Says Greater Investment Needed In Later-Stage Drug
R&D
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  Abstract: Governments should increase financial resources for novel antimicrobial drug candidates in the later stages of development and tackle shortages of... Related Stories
  Korean Bioclusters Offer Tax, Other Incentives To Attract Global Firms, Talent
  CDC Panel Backs Pfizer’s Maternal RSV Vaccine But Leaves Room For AstraZeneca/Sanofi’s Beyfortus
  EU Could Soon Have Three XBB.1.5 COVID-19 Vaccines For Winter Season
  PubDate: Wed, 20 Sep 2023 11:29:48 GMT
EMA Addresses Rapid Acting Therapies, Psychedelics In Updated Guidance On
Depression Treatments
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  Abstract: The European Medicines Agency is consulting on major changes to its decade-old guidance on the development of medicinal products for... Related Stories
  Korean Bioclusters Offer Tax, Other Incentives To Attract Global Firms, Talent
  CDC Panel Backs Pfizer’s Maternal RSV Vaccine But Leaves Room For AstraZeneca/Sanofi’s Beyfortus
  EU Could Soon Have Three XBB.1.5 COVID-19 Vaccines For Winter Season
  PubDate: Wed, 20 Sep 2023 10:27:15 GMT
Delivery Device Continues To Be Intarcia’s Downfall Ahead Of FDA Panel
On Nonapproval of Implantable GLP-1
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  Abstract: CDER reviewers don’t buy that safety concerns with exenatide implant ITCA 650 are in line with the risks labeled for... Related Stories
  EU Orphan Drug Law Reform Will See Innovation Drop By 12%, Industry Warns
  Intarcia’s Implantable GLP-1 Gets Unanimous No Vote But Lots Of New Trial Design Advice
  US FDA's Cavazzoni Criticizes Plant Shutdown That Triggered Serious Cisplatin Shortage
  PubDate: Wed, 20 Sep 2023 00:01:47 GMT
UK MHRA Gets A Grip On Spiralling Clinical Trial Assessment Timelines
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  Abstract: The UK medicines regulator says the loss of experienced staff and the need to recruit and train new assessors resulted... Related Stories
  New Swiss Database To Cut Costs Of GMP/GDP Certification
  Lack of Adequate Study Plan Prompts EMA Review Of Cardiovascular Risk With Mysimba
  From Interchangeability To Invisibility: FDA Wipes Designation From Biosimilar Labels
  PubDate: Tue, 19 Sep 2023 12:25:35 GMT