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Drug Development

      FDA Announces Removal of Black Box Warnings on HRT Products

      Americas
      The U.S. Department of Health and Human Services (HHS) announced a major policy shift today aimed at re-establishing what it described as gold-standard scientific...

      Amgen Announces Phase 3 VESALIUS-CV Clinical Trial Results

      Clinical Trials
      Amgen announced new detailed findings from its Phase 3 VESALIUS-CV clinical trial, revealing that Repatha (evolocumab) achieved statistically significant and clinically meaningful reductions in...

      FDA Grants Approval for CAPLYTA for MDD Treatment in Adults

      Americas
      Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has granted approval for CAPLYTA (lumateperone) to be used as an adjunctive...

      Building the Right Team and Resource Model to Support Quality System and Validation Activities

      Drug Development
      Since life science quality and validation projects can vary widely in scope and complexity, each specific project needs to be evaluated in order to...

      Merck and Blackstone Enter R&D Funding Agreement for sac-TMT

      Clinical Trials
      Merck, recognized as MSD outside the U.S. and Canada, has announced a funding arrangement with Blackstone Life Sciences to support the development of sacituzumab...

      FDA Approves J&J’s DARZALEX FASPRO for HR-SMM in Adults

      Americas
      Johnson & Johnson said the U.S. Food and Drug Administration (FDA) has cleared DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for use as a single-agent treatment...

      FDA Approves UCB’s KYGEVVI for Thymidine Kinase 2 Deficiency

      Americas
      UCB, a leading global biopharmaceutical company, has announced that KYGEVVI has received FDA approval for the treatment of adults and pediatric patients diagnosed with...

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      The Future of Digital Health

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      The pharmaceutical industry is acutely aware that the future of health and care, particularly in the United States, are trending toward a digital revolution....

      Five Best Practices to Deliver Exceptional Multichannel Experiences

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      A one-size-fits-all customer journey no longer works. In the age of the consumer, the quality of the interaction is paramount. In this paper, we...

      The Impact and Use of Social Media in Pharmacovigilance

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      Social media presents new channels and methods for biopharmaceutical companies to move away from traditional pharmacovigilance (PV) systems and safety reporting methods towards more...

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