Aducanumab: On the verge of making history in Alzheimer’s disease

When Biogen and Eisai terminated aducanumab’s Phase III program in early Alzheimer’s disease (AD) for futility in March 2019, a mere two months after Roche discontinued crenezumab, we wondered if it was the end of the line for anti-beta amyloid (Aβ) treatment in symptomatic AD. Shortly after the announcement, we removed all late-phase anti-Aβ drugs […]

The future of continuous manufacturing in pharma

Batch processing has been the standard manufacturing method used by the pharma industry for the last 50 years. But recent advances in manufacturing technology have resulted in a faster, more efficient process known as continuous manufacturing. How do the two processes compare? And what are regulators saying?   The Food and Drug Administration (FDA) describes […]

Trump targets drug prices – 5 implications for pharma

On July 24, 2020, President Trump signed several executive orders directing the secretary of Health and Human Services (HHS) to take steps to lower drug prices. The directive includes the following measures: 1. International pricing index The most aggressive policy directive tasks the HHS secretary with linking the price of Medicare prescription drugs to an […]

Patient enrollment continues to be a limiting factor for trial durations

To prepare for our recent webinar “Trends in Clinical Trial Planning,” we dug into proprietary data from The Centre for Medicines Research (CMR) International, a wholly owned subsidiary of Clarivate working with leading global pharmaceutical companies to provide insights into industry trends — to strengthen R&D planning and effectiveness.   The length of clinical trials […]

Understanding disruptions to the antibiotic supply resulting from COVID-19

The COVID-19 pandemic has highlighted vulnerabilities within the generic drug supply chain. To minimize the effects of antibiotic API supply disruptions, it is important to understand the underlying reasons for shortages to then identify the best-fit manufacturing partners.   The COVID-19 pandemic has disrupted the global drug supply, as manufacturing companies contend with government-mandated or […]

Retail Giants Reshaping Primary-Care Focus

Walgreens $1 billion in-store physician model may improve patient outcomes A series of partnerships and developments sweeping through the convenient care sector this past year is causing major drugstore retailers CVS-Aetna, Walgreens and Walmart – along with payers Blue Cross Blue Shield and Humana – to battle for control over patients’ healthcare decisions. These patients […]

Gaining insight with artificial intelligence

In part three of this blog series about best practices in toxicology, we continue the discussion from previous articles that outlined elements in the discovery stage that could impact safety, and considering a drug’s effects on toxicity of specific organs and specific patients via toxicogenomics, pharmacogenomics and pharmacoepigenomics. To help reach a deeper understanding of […]

Organ-specific toxicity and personalized approaches

In part two of this blog series about best practices in toxicology, we continue the discussion from the previous post, which described the aspects of drug discovery that could impact safety. Because safety can vary by person and organ, we also need to identify how we can determine a drug’s potential toxic effects on specific […]

Identifying risks in drug discovery

It is estimated that for every eight active substances entering Phase I clinical trials, only one product is approved and marketed.[1] The low success rate for clinical trials is largely driven by poor efficacy in humans and adverse events leading to the discontinuation of a drug development research program.[2] Findings related to the inherent properties […]

Which Exchanges Will UnitedHealth Enter in 2021?

On May 12, 2020, UnitedHealthcare announced that it filed to offer individual health plans in Maryland for 2021, and more announcements should be forthcoming UnitedHealth Group generated a buzz in its 2020 first quarter earnings call by revealing intentions to reenter health insurance exchanges in 2021. The insurer has a short history of offering plans […]