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  Subjects -> PHARMACY AND PHARMACOLOGY (Total: 575 journals)
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The Pink Sheet
Number of Followers: 15  
 
  Full-text available via subscription Subscription journal
ISSN (Online) 1530-6240
Published by Informa plc Homepage  [9 journals]
  • Supreme Court Seems To Support Government’s Later Dismissal Of False
           Claims Act Case

    • Free pre-print version: Loading...

      Abstract: Justices cite changing circumstances, constitutional concerns in preventing government from seeking dismissal of a case in which it initially declined...     Related Stories
      CMS-Manufacturer Discussion Of Medicare Price Negotiation Program Scheduled For 13 December
      Direction of Travel Of EU HTA Regulation Is ‘Disappointing’ For Advanced Therapies
      EU Health Ministers Want Changes to COVID-19 Vaccine Contracts Amid Oversupply Concerns 
      PubDate: Tue, 06 Dec 2022 21:29:34 GMT
       
  • CMS-Manufacturer Discussion Of Medicare Price Negotiation Program
           Scheduled For 13 December

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      Abstract: Agency reaches out to manufacturers as it develops its approach to implementing the controversial new program.     Related Stories
      Supreme Court Seems To Support Government’s Later Dismissal Of False Claims Act Case
      Direction of Travel Of EU HTA Regulation Is ‘Disappointing’ For Advanced Therapies
      EU Health Ministers Want Changes to COVID-19 Vaccine Contracts Amid Oversupply Concerns 
      PubDate: Tue, 06 Dec 2022 19:04:47 GMT
       
  • EU Health Ministers Want Changes to COVID-19 Vaccine Contracts Amid
           Oversupply Concerns

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      Abstract: EU member states are calling for a formal approach to making vaccine procurement agreements more flexible, saying that any further...     Related Stories
      Supreme Court Seems To Support Government’s Later Dismissal Of False Claims Act Case
      CMS-Manufacturer Discussion Of Medicare Price Negotiation Program Scheduled For 13 December
      Direction of Travel Of EU HTA Regulation Is ‘Disappointing’ For Advanced Therapies 
      PubDate: Tue, 06 Dec 2022 12:05:25 GMT
       
  • Direction of Travel Of EU HTA Regulation Is ‘Disappointing’
           For Advanced Therapies

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      Abstract: Without further work, the EU-wide joint clinical assessments introduced by the EU regulation on health technology assessments will fail to...     Related Stories
      Supreme Court Seems To Support Government’s Later Dismissal Of False Claims Act Case
      CMS-Manufacturer Discussion Of Medicare Price Negotiation Program Scheduled For 13 December
      EU Health Ministers Want Changes to COVID-19 Vaccine Contracts Amid Oversupply Concerns 
      PubDate: Tue, 06 Dec 2022 12:01:39 GMT
       
  • US FDA Oncology, Device Centers Developing Public Diagnostic Standards

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      Abstract: Pilot program would get around the ‘one drug, one test’ policy, which has created intellectual property issues.     Related Stories
      AAM CEO Leonard Departs After Two Years, Creating Another Trade Group Searching For New Leader
      AAM CEO Leonard Departs After Two Years; Generics Now 2nd Trade Group Searching For New Leader
      AAM CEO Leonard Departs After Two Years, Second Industry Trade Group Searching For New Leader 
      PubDate: Mon, 05 Dec 2022 23:48:36 GMT
       
  • CSL’s Hemgenix Gene Therapy Does Not Need A REMS, FDA Tells National
           Hemophilia Foundation

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      Abstract: Peter Marks says labeling for CSL’s hemophilia B treatment adequately conveys its risks. He also denies NHF request that the...     Related Stories
      Supreme Court Seems To Support Government’s Later Dismissal Of False Claims Act Case
      CMS-Manufacturer Discussion Of Medicare Price Negotiation Program Scheduled For 13 December
      Direction of Travel Of EU HTA Regulation Is ‘Disappointing’ For Advanced Therapies 
      PubDate: Mon, 05 Dec 2022 21:13:42 GMT
       
  • AAM CEO Leonard Departs After Two Years, Creating Another Trade Group
           Searching For New Leader

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      Abstract: David Gaugh, AAM’s executive VP of sciences and regulatory affairs, was named the interim CEO, making him the fourth person...     Related Stories
      AAM CEO Leonard Departs After Two Years; Generics Now 2nd Trade Group Searching For New Leader
      US FDA Oncology, Device Centers Developing Public Diagnostic Standards
      AAM CEO Leonard Departs After Two Years, Second Industry Trade Group Searching For New Leader 
      PubDate: Mon, 05 Dec 2022 20:51:41 GMT
       
  • Japan Discuss Faster AI Processing For Healthcare Sector

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      Abstract: As Japan?s PMDA reopens discussions on the appropriate regulation of AI in healthcare, a process which has so far focused...     Related Stories
      AAM CEO Leonard Departs After Two Years, Creating Another Trade Group Searching For New Leader
      AAM CEO Leonard Departs After Two Years; Generics Now 2nd Trade Group Searching For New Leader
      US FDA Oncology, Device Centers Developing Public Diagnostic Standards 
      PubDate: Mon, 05 Dec 2022 18:49:20 GMT
       
  • Novel Vaccines Among Wide-Ranging EU Plans To Boost Health Threat
           Preparedness

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      Abstract: Two documents published by the European Commission outline proposals to prepare for future health emergencies such as pandemics and the...     Related Stories
      Supreme Court Seems To Support Government’s Later Dismissal Of False Claims Act Case
      CMS-Manufacturer Discussion Of Medicare Price Negotiation Program Scheduled For 13 December
      Direction of Travel Of EU HTA Regulation Is ‘Disappointing’ For Advanced Therapies 
      PubDate: Mon, 05 Dec 2022 11:37:00 GMT
       
  • Cough Medicines Containing Pholcodine To Be Withdrawn In EU

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      Abstract: The opioid, which has been used as a cough suppressant since the 1950s, should no longer be marketed, according to...     Related Stories
      Supreme Court Seems To Support Government’s Later Dismissal Of False Claims Act Case
      CMS-Manufacturer Discussion Of Medicare Price Negotiation Program Scheduled For 13 December
      Direction of Travel Of EU HTA Regulation Is ‘Disappointing’ For Advanced Therapies 
      PubDate: Mon, 05 Dec 2022 07:30:45 GMT
       
  • To Prevent Shortages, US FDA Wants Sponsor To Provide Notifications Of
           Demand Spike

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      Abstract: Demand-related shortages are a relatively new problem, but the FDA maintains their tools can prevent or end them.     Related Stories
      AAM CEO Leonard Departs After Two Years, Creating Another Trade Group Searching For New Leader
      AAM CEO Leonard Departs After Two Years; Generics Now 2nd Trade Group Searching For New Leader
      US FDA Oncology, Device Centers Developing Public Diagnostic Standards 
      PubDate: Fri, 02 Dec 2022 18:43:00 GMT
       
  • Eisai Plots A Meticulous Path To Medicare Coverage For Lecanemab

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      Abstract: Ivan Cheung, Eisai’s US CEO, explains the ‘question-by-question’ the company is taking to convince the Centers for Medicare and Medicaid...     Related Stories
      FDA’s Robyn Bent On The Evolution of Patient-Focused Drug Development
      Exit Interview: US FDA’s Sandra Kweder Reflects On A 30-Year Career As She Heads Into Retirement 
      PubDate: Fri, 02 Dec 2022 18:28:18 GMT
       
  • US FDA’s Non-Cancer Accelerated Approval Drugs Get Their Own Public
           Databases

    • Free pre-print version: Loading...

      Abstract: Accelerated Approval Program web page links to searchable databases for accelerated approvals of infectious disease products, vaccines, and other nonmalignant...     Related Stories
      AAM CEO Leonard Departs After Two Years, Creating Another Trade Group Searching For New Leader
      AAM CEO Leonard Departs After Two Years; Generics Now 2nd Trade Group Searching For New Leader
      US FDA Oncology, Device Centers Developing Public Diagnostic Standards 
      PubDate: Fri, 02 Dec 2022 17:27:00 GMT
       
  • Recent And Upcoming FDA Advisory Committee Meetings

    • Free pre-print version: Loading...

      Abstract: Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.      Related Stories
      Supreme Court Seems To Support Government’s Later Dismissal Of False Claims Act Case
      CMS-Manufacturer Discussion Of Medicare Price Negotiation Program Scheduled For 13 December
      Direction of Travel Of EU HTA Regulation Is ‘Disappointing’ For Advanced Therapies 
      PubDate: Fri, 02 Dec 2022 17:24:00 GMT
       
  • Keeping Track: Rebyota, Rezlidhia Rev Up US FDA Approvals; New Sponsors
           Sought For Poziotinib, Brexafemme

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      Abstract: The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.     Related Stories
      Supreme Court Seems To Support Government’s Later Dismissal Of False Claims Act Case
      CMS-Manufacturer Discussion Of Medicare Price Negotiation Program Scheduled For 13 December
      Direction of Travel Of EU HTA Regulation Is ‘Disappointing’ For Advanced Therapies 
      PubDate: Fri, 02 Dec 2022 17:21:00 GMT
       
  • EU Countries Slam Transferable Exclusivity Voucher Proposal

    • Free pre-print version: Loading...

      Abstract: A group of EU member states has written to the European Commission saying that an exclusivity voucher scheme intended to...     Related Stories
      EMA To Address Problems With CTIS By Key January Deadline
      Pharma Could Face Fewer False Claims Act Suits If Supreme Court Concurs With Government
      Obesity Drug Coverage In ACA Plans May Expand With Shift In Treatment Classification Standard 
      PubDate: Fri, 02 Dec 2022 12:30:33 GMT
       
  • EMA To Address Problems With CTIS By Key January Deadline

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      Abstract: The EU’s single-portal Clinical Trial Information System will become mandatory from 31 January 2023 for sponsors seeking clinical trial approval...     Related Stories
      EU Countries Slam Transferable Exclusivity Voucher Proposal
      Pharma Could Face Fewer False Claims Act Suits If Supreme Court Concurs With Government
      Obesity Drug Coverage In ACA Plans May Expand With Shift In Treatment Classification Standard 
      PubDate: Fri, 02 Dec 2022 07:47:38 GMT
       
  • Pharma Firms Must Act On Biodiversity Footprinting To Avoid Business Risks

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      Abstract: Biodiversity footprinting may still be a new concept for pharmaceutical companies, but they need to put a clear supply chain...     Related Stories
      Accelerated Approval Is For Patients, Not Sponsors – US FDA’s Pazdur
      Lunsumio Provides First Test For Korea?s Breakthrough Therapy Program
      US FDA Says Confirmatory Trials Should Start Before Accelerated Approval But Is Not ‘Dogmatic’ 
      PubDate: Fri, 02 Dec 2022 07:07:24 GMT
       
  • Pharma Could Face Fewer False Claims Act Suits If Supreme Court Concurs
           With Government

    • Free pre-print version: Loading...

      Abstract: High court is to determine whether the government can dismiss an FCA complaint after initially declining to take it on...     Related Stories
      EU Countries Slam Transferable Exclusivity Voucher Proposal
      EMA To Address Problems With CTIS By Key January Deadline
      Obesity Drug Coverage In ACA Plans May Expand With Shift In Treatment Classification Standard 
      PubDate: Thu, 01 Dec 2022 23:25:00 GMT
       
  • Obesity Drug Coverage In ACA Plans May Expand With Shift In Treatment
           Classification Standard

    • Free pre-print version: Loading...

      Abstract: Current drug classification standard was originally designed for the Medicare Part D program, which does not cover obesity drugs.     Related Stories
      EU Countries Slam Transferable Exclusivity Voucher Proposal
      EMA To Address Problems With CTIS By Key January Deadline
      Pharma Could Face Fewer False Claims Act Suits If Supreme Court Concurs With Government 
      PubDate: Thu, 01 Dec 2022 23:24:00 GMT
       
 
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