• The Tariff Mitigation Toolkit

    For US-based pharmaceuticals companies attempting to minimize the effects of tariffs, one thing has become crystal clear: very little is crystal clear. read more
  • The Dog Days of Summer

    As I write this in the middle of August, during an oppressively humid heat wave, the term “the dog days of summer” comes to mind. If you have never heard that term, it refers to the hottest, most stifling period of summer. Quite apropos, as we are currently experiencing a heat wave. But where did the term come from? read more
  • A Critical Inflexion Point: The Indisputable Case for Next-Gen Pharmacovigilance

    Adverse event case processing is an enormous cost center and compliance issue for life sciences. As revenues stagnate for many pharma companies and profits come under new pressures, the expectation to improve its operational efficiency is substantial. But that cannot be at the expense of quality, or patient safety – the very purpose of pharmacovigilance. Organizations and their PV service providers have no choice but to take a smarter approach, underpinned by artificial intelligence and advanced automation. The cost and risk management benefits are clear, while the wider gains will include a more proactive PV operation, says Qinecsa’s John Cogan. read more
  • An ADME Guide for Successful siRNA Therapeutics: Insights from Approved Drugs

    Small interfering RNA (siRNA) therapeutics have emerged as a trans formative class of drugs, offering targeted gene silencing capabilities that hold promise for treating various diseases. Since the landmark approval of the first siRNA drug Patisiran in 2018, the therapeutic siRNA landscape has expanded significantly, with multiple drugs, including Givosiran, Lumasiran, Inclisiran, and Vutrisiran, now approved in both the US and EU markets. Understanding these drugs’ absorption, distribution, metabolism, and excretion (ADME) characteristics is critical for optimizing their development and clinical application of siRNA therapeutics. read more